[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-depression":671},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,49,84,116,139,169,196,223,252,265,288,313,323,345,371,395,421,447,470,497,532,556,595,620,645],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053310",false,"NCT07226011","Accelerated High-Dose tDCS for Depression","Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study","Inclusion Criteria:\n\n* Ages 18-70.\n* Current MDD diagnosis (MINI v7).\n* Baseline PHQ-9 \\> 9.\n* Capacity to consent\n* Fluent English.\n\nExclusion Criteria:\n\n* Bipolar or psychotic disorder\n* Primary anxiety disorders without concomitant major depression as defined above\n* Current significant suicidal ideation or behaviors require a higher level of care.\n* Use of neuromodulation therapies (e.g., ECT, TMS, VNS) within the past 6 months.\n* History of seizures, implanted cranial\u002F cardiac metal, or neurosurgery.\n* Use of medications that significantly reduce seizure threshold\n* Frequent\u002Fsevere HA\n* Personal history of head trauma, concussion, or TBI\n* Catatonic or otherwise unable to perform the consent process\n* Current alcohol or substance-use disorder (moderate-severe).\n* Any non-uniformities in the skin under the electrode site, including eczema, severe rashes, hyperhidrosis, communicable skin disorders, sensitive skin (ex. eczema, severe rashes), blisters, open wounds, burns including sunburns, cuts or irritation (e.g. due to shaving), or other skin defects or lesions, as determined by clinical personnel\n* Pregnancy (urine test required for women of childbearing potential).","ALL","18 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","In this study, investigators are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp.\n\nThe study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. Investigators will check skin comfort, mood, and overall tolerability after each session.",[27,28],"Major Depression","Major Depression Disorders",[30,31,32,33,34,35],"Depression","Nervous System","tDCS","Interventional","Brain Stimulation","Transcranial Direct Stimulation","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2025-12-15",{"date":44,"type":21},"2026-10-01",{"name":46,"class":47},"Medical University of South Carolina","OTHER",1,{"id":50,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100054040","NCT07562191","Inhaled DMT for Major Depressive Disorder","Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder","DMT-MDD","Inclusion Criteria:\n\n* 18 years or older, capable of making decisions, and able to provide informed consent.\n* Major Depressive Disorder (MDD) according to DSM-5 criteria\n* Current depressive episode of moderate to severe intensity\n* Episode duration of at least two weeks\n* Baseline MADRS score ≥ 20\n* No treatment changes (including antidepressants) in the 4 weeks prior to the study\n* Abstain from psychedelics ≥14 days before dosing (D0)\n\nExclusion criteria:\n\n* Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions\n* Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma\n* Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma\n* Neurological risk (e.g., aneurysm, ↑ICP, epilepsy\u002Fseizures, severe disorders)\n* MAO deficiency or history of serotonin syndrome\n* Pregnant, breastfeeding, positive test, or no effective contraception\n* Secondary depression\n* Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport\n* Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis\u002Fbipolar disorder\n* Mania\u002Fhypomania\n* OCD, dissociative disorders, active PTSD, or decompensated eating disorders\n* Moderate-severe use disorder (past 6 months; except nicotine\u002Fcaffeine)\n* Lifetime ketamine, PCP, psychedelics, or MDMA use disorder\n* Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing\n* Psychedelic trial participation in past 12 months\n* Cognitive impairment affecting valid assessment",{"count":57,"type":21},140,[59],"PHASE2","This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD).\n\nThe study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT.\n\nParticipants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.",[62,63,27,64,65],"MDD","Major Depressive Disorder (MDD)","Suicidal Ideation","Suicide",[67,68,69,70,71,72,73,74],"DMT","major depressive disorder","N,N-dimethyltryptamine","psychedelic therapy","inhaled DMT","vaporized DMT","suicidality","non invasive","2026-07-09",{"date":39,"type":40},{"date":78,"type":21},"2026-08-01",{"date":80,"type":21},"2027-08-01",{"name":82,"class":47},"Universidade Federal do Rio Grande do Norte",5,{"id":85,"slug":4,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":48},"100644817","NCT07673913","Relationship of Peripheral Inflammatory and Neuroprotective Biomarkers With Response to Intermittent Theta Burst Stimulation in Treatment-Resistant Depression","Relationship Between Response to Transcranial Magnetic Stimulation and Peripheral Inflammatory and Neuroprotective Biomarkers in Patients With Treatment-Resistant Depression","TRD-BIOTMS","Inclusion Criteria:\n\nTreatment-Resistant Depression Group:\n\nAge between 18 and 55 years. Male or female participants. Diagnosis of Major Depressive Disorder according to DSM-5-TR criteria. Inadequate response to at least two antidepressant treatments administered at adequate doses and durations.\n\nEligible for transcranial magnetic stimulation (TMS) treatment. Able and willing to provide written informed consent. Able to complete neuropsychological assessments. Able to attend study visits and complete the treatment protocol.\n\nHealthy Control Group:\n\nAge between 18 and 55 years. Male or female participants. No current DSM-5-TR psychiatric disorder. Able and willing to provide written informed consent. Able to complete neuropsychological assessments.\n\nExclusion Criteria:\n\nSchizophrenia, bipolar disorder, organic mental disorders, or other major psychiatric disorders.\n\nHistory of epilepsy, brain tumor, severe head trauma, or significant neurological disease.\n\nAny contraindication to TMS. Presence of intracranial metal implants, cardiac pacemakers, cochlear implants, or other incompatible implanted devices.\n\nActive infection. Autoimmune disease or chronic inflammatory disease. Electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation within the previous 5 years.\n\nPrevious intravenous or intranasal ketamine treatment. Pregnancy or breastfeeding. Active alcohol or substance use disorder. Inability to comply with study procedures. Inability to tolerate the iTBS protocol. Withdrawal of informed consent at any stage of the study.",true,"55 Years",{"count":94,"type":21},100,[24],"Treatment-resistant depression (TRD) is a major clinical challenge affecting a substantial proportion of patients with major depressive disorder who do not adequately respond to conventional antidepressant treatments. Intermittent theta burst stimulation (iTBS), a non-invasive neuromodulation technique targeting the left dorsolateral prefrontal cortex, has emerged as an effective treatment option for these patients. However, the biological mechanisms underlying treatment response remain poorly understood.\n\nThis single-center, prospective, investigator-initiated clinical study aims to investigate the effects of iTBS on clinical symptoms, executive functions, and peripheral inflammatory and neuroprotective biomarkers in patients with treatment-resistant depression.\n\nFifty patients with treatment-resistant depression and fifty healthy control participants will be enrolled. Patients will receive active iTBS treatment for four weeks (20 sessions), while healthy controls will undergo baseline clinical, cognitive, and biological assessments without receiving any intervention.\n\nClinical outcomes will be evaluated using the 17-item Hamilton Depression Rating Scale (HAM-D-17), Patient Health Questionnaire-9 (PHQ-9), Clinical Global Impression (CGI), and Insomnia Severity Index (ISI). Executive functions will be assessed using the Wisconsin Card Sorting Test, Trail Making Test A and B, and verbal fluency tests.\n\nPeripheral blood samples will be collected before and after treatment to measure inflammatory, neuroplasticity, and neuroprotective biomarkers, including IL-1β, IL-6, IL-10, TNF-α, high-sensitivity C-reactive protein (hs-CRP), brain-derived neurotrophic factor (BDNF), apolipoprotein D (APOD), serum amyloid A1 (SAA1), and serum amyloid A2 (SAA2). Gene expression analyses will also be performed using quantitative polymerase chain reaction (qPCR).\n\nThe study aims to identify biological mechanisms associated with iTBS treatment response and to explore potential biomarkers that may predict clinical improvement in patients with treatment-resistant depression. The findings may contribute to the development of personalized neuromodulation strategies and biomarker-guided treatment approaches for depression.",[98,27],"Treatment-resistant Depression (TRD)",[100,101,102,103,104],"Treatment-Resistant Depression","Transcranial Magnetic Stimulation","Biomarkers","Personalized Psychiatry","Neuromodulation","NOT_YET_RECRUITING","2026-06-23",{"date":108,"type":40},"2026-06-29",{"date":110,"type":21},"2026-09-01",{"date":112,"type":21},"2027-09-01",{"name":114,"class":115},"Gulhane Training and Research Hospital","OTHER_GOV",{"id":117,"slug":4,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":91,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":83},"100643022","NCT07649993","Non-Coding RNAs Gene Expression in Psychiatric Disorders","Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders","PsiRNA26","Inclusion Criteria (patients):\n\n* Age between 18 and 55 years;\n* Male sex or female sex in the mid-luteal phase of the menstrual cycle;\n* Clinical presentation consistent with diagnostic criteria for:\n* Bipolar Disorder type I or II,\n* Panic Disorder,\n* Major Depressive Disorder,\n* Obsessive-Compulsive Disorder,\n* Schizophrenia;\n* First diagnosis and drug-naive status, or absence of psychopharmacological treatment for at least 6 months prior to enrollment.\n\nInclusion Criteria (Healthy Control):\n\n* Age between 18 and 55 years;\n* Male sex or female sex in the mid-luteal phase of the menstrual cycle;\n* No treatment with psychotropic medications;\n* Absence of clinical elements supporting a diagnosis of Bipolar Disorder, Panic Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder, Schizophrenia;\n* Absence of clinical or laboratory evidence of infectious or internal medicine diseases;\n* Absence of autoimmune diseases;\n* HAM-D score \\\u003C 8;\n* MRS score \\\u003C 11;\n* Y-BOCS score \\\u003C 7;\n* BPRS score = 18;\n* No significant stressful life events during the previous 6 months.\n\nExclusion Criteria (patients):\n\n* Current immunosuppressive, antibiotic, or hormone replacement therapy;\n* Relevant medical comorbidities, including autoimmune or internal medicine disorders;\n* Active infectious diseases or infections resolved less than 3 weeks before enrollment;\n* Relevant psychiatric comorbidities;\n* Current psychopharmacological treatment or discontinuation of psychopharmacological therapy less than 6 months before enrollment.",{"count":124,"type":21},384,"OBSERVATIONAL","This study aims to investigate whether specific non-coding RNAs, molecules involved in the regulation of gene expression, are altered in individuals with psychiatric disorders such as schizophrenia, bipolar disorder, major depressive disorder, panic disorder, and obsessive-compulsive disorder. Researchers will compare the expression levels of these molecules in patients who are drug-naïve or have been free from psychiatric treatment for at least six months with those observed in healthy volunteers.\n\nThe study will also evaluate whether the expression of these non-coding RNAs changes after approximately five months of standard psychiatric treatment. Blood samples collected during routine clinical care will be used to measure the expression levels of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR), a laboratory technique used to assess gene expression.\n\nThis is an observational study and does not assign specific treatments. All therapies will be prescribed according to standard clinical practice.\n\nThe main objective is to determine whether alterations in non-coding RNA expression may serve as biological markers of psychiatric disorders and whether these markers may help monitor treatment-related changes over time. The findings may contribute to a better understanding of the biological mechanisms underlying major psychiatric disorders and support the future development of more accurate diagnostic and therapeutic approaches.",[128,27,129,130,131],"Schizophrenia Disorders","Bipolar Affective Disorders","Obsessive Compulsive Disorder (OCD)","Anxiety Disorder (Panic Disorder or GAD)","2026-06-18",{"date":106,"type":40},{"date":110,"type":21},{"date":136,"type":21},"2028-09-01",{"name":138,"class":47},"Carmen Concerto",{"id":140,"slug":4,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":91,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":48},"100579447","NCT06824415","Sleep TMS for Depression","Optimizing Depression Treatment Through Sleep-state Brain Stimulation","Inclusion Criteria:\n\n* Adults ages 18-65 years\n* Current Major Depressive Disorder (MDD) diagnosis\n* Failed ≥1 antidepressant medication\n* Moderate-to-severe depression\n* Stable antidepressant medication dose for ≥ 6 weeks prior to enrollment\n* Healthy control participants are adults ages 18-65 years without current MDD symptoms, not taking antidepressant or antipsychotic medications, and without major psychiatric, neurological, substance use, medical conditions affecting brain function, or TMS\u002FMRI contraindications.\n\nExclusion Criteria:\n\n* Intellectual disability\n* Significant head injury\u002Fneurological disorder\n* Pregnancy or postpartum\n* TMS\u002FMRI contraindications\n* Active substance use\u002Fsuicidal ideation","65 Years",{"count":147,"type":21},55,[24],"The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.",[27,151],"Sleep",[153,154,155,156,157,158,159,160,161],"sleep","tms","eeg","iTBS","real-time","closed-loop","NREM","sleep spindle","slow oscillations",{"date":106,"type":40},{"date":164,"type":40},"2025-05-01",{"date":166,"type":21},"2028-05-30",{"name":168,"class":47},"Stanford University",{"id":170,"slug":4,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":91,"sex":16,"minAge":174,"maxAge":18,"enrollmentInfo":175,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":48},"100490713","NCT05669703","NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Aged 8 and older\n3. Probands must have at least one first-degree relative agree to participate\n4. Affected probands must have a lifetime history of a mood disorder\n5. Unaffected probands must have no lifetime history of a mood disorder\n6. In good general health as evidenced by medical history\n7. Agreement to adhere to Lifestyle Considerations throughout study duration\n8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy\n2. People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).","8 Years",{"count":176,"type":21},1260,"Background:\n\nMood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.\n\nObjective:\n\nTo better understand relationships among physical activity, sleep, and mental health.\n\nEligibility:\n\nPeople aged 8 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.\n\nDesign:\n\nParticipants will be in the study up to 2 years.\n\nFor up to 20 days in a row, at 4 times during the study, participants will:\n\nComplete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.\n\nWear an activity monitor, like a wristwatch, that records how much they move.\n\nWear a light sensor, as a necklace, to record the amount of light in their environment.\n\nSome participants will do additional tests. Twice during the study, for 3 days in a row, they will:\n\nWear monitors to record their temperature, heart rate, and sleep.\n\nProvide saliva samples.\n\nComplete cognitive tasks on their smartphone.\n\nParticipants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.\n\nSome participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.",[179,27,180],"Bipolar Disorder","Migraine",[182,183,184,151,185,186],"Mood Disorders","Actigraphy","CIRCADIAN RHYTHMS","Ecological Momentary Assessments","Natural History",{"date":188,"type":40},"2026-06-22",{"date":190,"type":40},"2023-11-03",{"date":192,"type":21},"2026-07-31",{"name":194,"class":195},"National Institute of Mental Health (NIMH)","NIH",{"id":197,"slug":4,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":48},"100360448","NCT03973268","Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression","The Mechanism of Action Underlying Ketamine's Antidepressant Effects: An Investigation of the AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression","* INCLUSION CRITERIA:\n\nPhases I-II\n\n1. 18 to 70 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\".\n4. Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P).\n5. Subjects must have an initial score on the MADRS greater than or equal to 22 and a YMRS score of \\\u003C12 within one week of study entry and upon entry into Phase II.\n6. Lack of response to two adequate antidepressant trials, with \\[at least\\] one in the current major depressive episode, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT \\[or TMS\\] would count as an adequate antidepressant trial.\n7. Current major depressive episode lasting at least four weeks\n8. Agree to be hospitalized\n\nOpen-Label Ketamine Treatment\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhases I-II\n\n1. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n2. Subjects with a history of substance abuse or dependence diagnosis (DSM-IV) or substance use disorder (DSM-5 equivalent) (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screening and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) at screening.\n3. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n4. Pregnant or nursing individuals or those who are physically able to become pregnant. Participants who are physically able to become pregnant or cause a pregnancy must use at least one form of effective birth control or remain completely abstinent from sexual intercourse during the entire period of study participation (or until the last clinical labs and ratings). Participants able to become pregnant must have negative urine pregnancy tests no more than 24 hours prior to receiving the study drugs and undergoing imaging procedures.\n5. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures.\n6. Presence of any medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n7. Clinically significant abnormal laboratory tests.\n8. (For imaging procedures) Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n9. Positive HIV test\n10. Weight \\> 119 kg\n11. Treatment with any concomitant psychiatric medication prior to entering Phase II. \\[Medications must be tapered during Phase I.\\]\n12. Treatment with any non-psychiatric medication\u002Fs.\n13. Any use of opioid medication in the past 3 months\n14. Treatment with a reversible monoamine oxidase inhibitor (MAOI) prior to entering Phase II. \\[Medications must be tapered during Phase I.\\]\n15. Treatment with fluoxetine or aripiprazole at the time of screening.\n16. Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study.)\n17. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clip).\n18. Participants who are uncomfortable in small closed spaces (have claustrophobia).\n19. Are unable to lie comfortably supine for up to 90 minutes and would feel uncomfortable in the MRI and MEG machines.\n20. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n21. Subjects who have a history of aggressive behavior towards others\n22. A current NIMH employee\u002Fstaff or their immediate family member\n\nOpen-Label Ketamine Treatment\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Participants with a positive urine for an illicit substance no more than 24 hours prior to ketamine treatment.\n3. Pregnant or nursing individuals or those who plan to become pregnant.",{"count":203,"type":21},70,[205],"PHASE1","Background:\n\nMost drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works.\n\nObjective:\n\nTo see if the antidepressant response of ketamine is linked to AMPA receptors.\n\nEligibility:\n\nAdults ages 18-70 with major depression disorder without psychotic features\n\nDesign:\n\nParticipants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam.\n\nParticipants will stay at the NIH Clinical Center for 5 weeks.\n\nPhase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests:\n\n* Blood draws\n* Psychological tests\n* MRI: Participants will lie in a machine that takes pictures of their brain.\n* MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity.\n* Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep.\n* Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity.\n\nFor phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.",[30,208,27],"Major Depressive Disorder",[210,211,212,213,214],"Biomarker","AMPA Antagonist","Magnetoencephalography","Neuropharmacology","Neurobiology","2026-06-13",{"date":217,"type":40},"2026-06-16",{"date":219,"type":40},"2020-01-21",{"date":221,"type":21},"2027-02-01",{"name":194,"class":195},{"id":224,"slug":4,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":83},"100610334","NCT07226232","Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression","A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans","PIVOT","Inclusion Criteria:\n\n* Veteran of the U.S. military who is English-speaking\n* Signed informed consent and HIPAA\n* Adults \\\u003C\u002F= 75 years of age\n* Meets DSM-5 criteria for current major depressive episode (MDE)\n* MADRS \\>\u002F= 20 at baseline\n* Failure to respond satisfactorily to \\>\u002F= 2 antidepressant treatments for \\>\u002F= 8 weeks, including \\>\u002F= 2 weeks at an adequate dose (\\>\u002F= 50% of the FDA-approved uppermost dose) for major depression. Augmentation with a medication for depression (e.g., neuroleptics, lithium, levothyroxine) is considered a separate course of treatment.\n* If applicable, concurrent \\& permitted antidepressants must be at stable doses for \\>\u002F= 4 weeks prior to baseline (see allowed \\& prohibited medication list)\n* Participants of child-bearing potential must have negative pregnancy test \\& agree to adhere to a medically acceptable method of birth control during the study\n* Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration\n\nExclusion Criteria:\n\n* Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders\n* First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder\n* Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)\n* Sedative-hypnotic, stimulant, inhalant and\u002For opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)\n* Severe alcohol and\u002For cannabis use disorder within the past 6 months (mild or moderate alcohol and\u002For cannabis use is allowed at the discretion of the LSI)\n* Lifetime hallucinogen persisting perception or hallucinogen use disorders\n* Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past 6 months\n* Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol\n* Taking prohibited medication within 2 weeks of baseline (see allowed and prohibited concomitant medication list)\n* History of severe traumatic brain injury (TBI)\n* Diagnosis of dementia or related progressive neurocognitive disorder\n* Suicidal ideation\u002Fbehavior Type 4 or Type 5 intensity on C-SSRS within past 6 months of baseline\n* Psychiatric inpatient treatment within past 3 months of baseline\n* Treatment with electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within 3 months of baseline\n* Implanted central nervous system device\n* Treatment with evidence-based psychotherapy (EBP) for MDD or PTSD within 2 weeks prior to baseline. If receiving EBP therapy, he\u002Fshe must complete treatment at least 2 weeks prior to baseline. Other forms of non-EBP psychotherapy for MDD or PTSD are allowed to continue during the study period.\n* Pregnancy or lactation, or anticipated pregnancy or breastfeeding during the active treatment phase\n* History of myocardial infarction, congestive heart failure, diabetic ketoacidosis, brain cancer, stroke and\u002For severe cardiac disease\n* Clinically significant cardiac, pulmonary, renal, liver and\u002For other medical disease that, in the opinion of the investigator, may contraindicate the use of psilocybin, interfere with the interpretation of study results and\u002For constitute a health risk for the participant if they take part in the study\n* Seizure disorder, except for seizures due to fever or withdrawal from a substance\n* Clinically significant hypertension (\\>160\u002F95 mmHg), hypotension (\\\u003C90\u002F60 mmHg) tachycardia (\\>100 bpm at rest), QTc prolongation (\\>450 msec men; \\>470 msec women) or clinically significant arrhythmia on ECG\n* Clinically significant abnormal laboratory results on chemistry panel, liver function tests, complete blood count, and\u002For thyroid stimulating hormone\n* Positive urine drug screen for illicit drugs of abuse (except for THC) at screening or baseline\n* Prior allergic, adverse reaction or adverse experience to a psilocybin formulation\n* Litigating for disability income for a mental disorder outside the VA compensation and pension process","75 Years",{"count":232,"type":21},240,[234],"PHASE3","The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.",[27],[238,239,240,241],"depression","psilocybin","veterans","post-traumatic stress disorder","2026-06-03",{"date":244,"type":40},"2026-06-05",{"date":246,"type":21},"2026-07-30",{"date":248,"type":21},"2031-06-30",{"name":250,"class":251},"VA Office of Research and Development","FED",{"id":253,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":60,"conditions":257,"keywords":258,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":264,"locationsCount":83},"100636169","Inclusion Criteria:\n\n* 18 years or older, capable of making decisions, and able to provide informed consent.\n* Major Depressive Disorder (MDD) according to DSM-5 criteria\n* Current depressive episode of moderate to severe intensity\n* Episode duration of at least two weeks\n* Baseline MADRS score ≥ 20\n* No treatment changes (including antidepressants) in the 4 weeks prior to the study\n* Abstain from psychedelics ≥14 days before dosing (D0) and during the 12-month follow-up\n\nExclusion criteria:\n\n* Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions\n* Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma\n* Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma\n* Neurological risk (e.g., aneurysm, ↑ICP, epilepsy\u002Fseizures, severe disorders)\n* MAO deficiency or history of serotonin syndrome\n* Pregnant, breastfeeding, positive test, or no effective contraception\n* Secondary depression\n* Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport\n* Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis\u002Fbipolar disorder\n* Mania\u002Fhypomania (YMRS ≥8)\n* OCD, dissociative disorders, active PTSD, or decompensated eating disorders\n* Moderate-severe use disorder (past 6 months; except nicotine\u002Fcaffeine)\n* Lifetime ketamine, PCP, psychedelics, or MDMA use disorder\n* Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing\n* Psychedelic trial participation in past 12 months\n* Cognitive impairment affecting valid assessment",{"count":57,"type":21},[59],[62,63,27,64,65],[67,68,69,70,71,72,73,74],"2026-05-22",{"date":261,"type":40},"2026-05-28",{"date":78,"type":21},{"date":80,"type":21},{"name":82,"class":47},{"id":266,"slug":4,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":91,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":286,"locationsCount":48},"100637968","NCT07593222","Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder","Inclusion Criteria:\n\n* Can safely receive TMS and study drugs\n* Stable medication regimen for one month prior to study participation, and for the duration of the study\n* Not currently receiving TMS, ECT, or ketamine\n* No active safety concerns related to suicidality\n\nExclusion Criteria:\n\n* History of seizures or epilepsy\n* History of intracranial pathology or lesions from any etiology\n* History of traumatic brain injury including prolonged loss of consciousness more than 15 min\n* Signs of increased intracranial pressure\n* Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.)\n* Major medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Severe migraines that may result in treatment intolerance.\n* Inability to tolerate MRI.\n* Pregnancy\n* Known allergic reaction to d-cycloserine or dextromenthorphan",{"count":94,"type":21},[205,59],"Many people with depression do not get better with standard treatments like medications or talk therapy. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation treatment that uses magnetic pulses to stimulate areas of the brain involved in depression. One form of TMS called intermittent theta burst stimulation (iTBS) is FDA-cleared for depression and takes only 3 minutes to deliver. However, about one-third of patients do not respond to iTBS, and another one-third do not reach full remission. Improving iTBS requires a better understanding of how it works in the brain.\n\niTBS is thought to work by strengthening connections between brain cells, a process called synaptic plasticity. This process depends on a type of brain receptor called the NMDA receptor. Most of what researchers know about how iTBS affects these connections comes from studies of healthy people. It is not known whether iTBS works the same way in the prefrontal cortex - the brain region targeted during depression treatment - or in people who actually have depression.\n\nThis study has two phases.\n\nIn Phase 1, both healthy volunteers and people with depression will complete 4 research visits to test how iTBS changes brain activity in the prefrontal cortex and whether medications that increase or decrease NMDA receptor activity change those effects. Each visit involves active or sham (inactive) iTBS combined with one of three study medications: a placebo (inactive pill), d-cycloserine (a medication that increases NMDA receptor activity), or dextromethorphan (a medication that decreases NMDA receptor activity). Brain activity is measured before and after each TMS session using electroencephalography (EEG), a painless test that records electrical signals from the scalp through a cap placed on the head. All participants also complete a brain MRI before beginning study visits for targeting purposes.\n\nIn Phase 2, participants with depression will be offered a standard clinical course of 30 daily iTBS sessions (Monday through Friday over 6 weeks). Each session is combined with one blinded study medication (placebo, d-cycloserine, or dextromethorphan) taken daily. Brain activity measurements and standard depression and anxiety questionnaires are collected weekly throughout this phase to track how the brain changes over the course of treatment and whether those changes relate to improvements in symptoms.\n\nTogether, the two phases of this study aim to identify the brain mechanism by which iTBS works in people with depression. This knowledge could lead to more effective TMS treatments for people who have not responded to medications or other therapies.",[27,274],"Healthy Participants",[276,238,277,278,279],"TMS","EEG","transcranial magnetic stimulation","pharmacologic augmentation","2026-05-13",{"date":282,"type":40},"2026-05-18",{"date":284,"type":21},"2026-07-01",{"date":248,"type":21},{"name":287,"class":47},"Mclean Hospital",{"id":289,"slug":4,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":83},"100622194","NCT07380451","Modular Intervention for Depression Study","Modular Optimization of Psychotherapy for Individuals With Depression Complicated by Personality Dysfunction and Complex Trauma: A Pilot Study in the Chilean Public Health System","MIND","Inclusion Criteria:\n\n* Current diagnosis of major depressive disorder, defined as:\n\n  * Positive diagnosis on the MINI diagnostic interview, and\n  * PHQ-9 score greater than 10\n* Evidence of personality dysfunction, defined as a score above the cutoff on the Level of Personality Functioning Scale-Brief Form (LPFS-BF 2.0).\n* History of moderate to severe early life adversity, defined as elevated scores on at least one scale of the Childhood Trauma Questionnaire (CTQ), and\u002For clinically significant alterations in self-organization.\n* Presence of at least one elevated domain of alteration of self-organization, including emotion regulation difficulties, interpersonal sensitivity, and\u002For interpersonal functioning problems, as assessed by standardized self-report measures (DERS, A-RSQ, OQ-45-IR).\n* Receiving care at a participating public community mental health center in Chile.\n* Ownership of a smartphone (Android or iOS) with internet access and an active data plan.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI.\n* Any severe psychiatric disorder other than major depressive disorder that is the primary clinical diagnosis, including:\n\n  * Schizophrenia or other psychotic disorders\n  * Bipolar I disorder\n* Severe substance use disorder, active within the past 6 months.\n* Diagnosis of post-traumatic stress disorder (PTSD) meeting full diagnostic criteria, as assessed by standardized instruments (ITEM and ITQ).\n* Meeting diagnostic criteria for:\n\n  * Antisocial personality disorder (two or more criteria), or\n  * Borderline personality disorder with more than three diagnostic criteria\n* Severe medical, cognitive, or psychosocial condition that would interfere with participation in weekly psychotherapy.\n* Concurrent participation in another active psychotherapy or initiation\u002Fchange of psychotropic medication during the study period, except for:\n\n  * Stable antidepressant treatment\n  * Medications prescribed for sleep\n  * Benzodiazepines used only on an as-needed (PRN) basis.\n* Inability to comply with study procedures or assessments.",{"count":296,"type":21},150,[24],"The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and\u002For complex trauma in adults aged 18 to 65 receiving care in the Chilean public mental health system.\n\nThe main questions it aims to answer are:\n\n* Does algorithm-based modular psychotherapy lead to greater clinically significant reduction and remission of depressive symptoms compared to usual psychotherapy?\n* Does algorithm-based modular psychotherapy lead to greater improvement in emotional regulation, interpersonal functioning, and self-related functioning, including changes observed in daily life?\n\nResearchers will compare algorithm-based modular psychotherapy to usual individual psychotherapy provided in public community mental health centers to see if the modular, personalized approach results in better clinical outcomes, stronger therapeutic alliance, and higher treatment satisfaction.\n\nParticipants will:\n\n* Be randomly assigned to receive either algorithm-based modular psychotherapy or usual individual psychotherapy\n* Attend weekly individual psychotherapy sessions\n* Complete structured diagnostic interviews and self-report questionnaires before, during, and after treatment\n* Provide brief daily reports on mood, emotions, and interpersonal experiences using a smartphone before and after treatment",[27],[301,302,303],"Complicated Depression","Early Life Adversity","Personality Dysfunction","2026-05-11",{"date":306,"type":40},"2026-05-12",{"date":308,"type":21},"2026-05-01",{"date":310,"type":21},"2028-02-28",{"name":312,"class":47},"Pontificia Universidad Catolica de Chile",{"id":314,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":25,"conditions":317,"keywords":318,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":321,"leadSponsor":322,"locationsCount":48},"100610317",{"count":20,"type":21},[24],[27,28],[30,31,32,33,34,35],{"date":306,"type":40},{"date":42,"type":40},{"date":78,"type":21},{"name":46,"class":47},{"id":324,"slug":4,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":48},"100636068","NCT07560878","Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression","SyncT","Inclusion Criteria:\n\n* Can safely receive TMS and study drugs\n* Stable medication regimen for one month prior to study participation, and for the duration of the study\n* Not currently receiving TMS, ECT, or ketamine\n* No active safety concerns related to suicidality\n* Moderate to severe Major Depressive Disorder as indicated by the Patient Health Questionnaire or Quick Inventory of Depressive Symptomatology\n\nExclusion Criteria:\n\n* History of seizures or epilepsy\n* History of intracranial pathology or lesions from any etiology\n* History of traumatic brain injury including prolonged loss of consciousness more than 15 min\n* Signs of increased intracranial pressure\n* Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.)\n* Major medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Severe migraines that may result in treatment intolerance.\n* Inability to tolerate MRI.\n* Pregnancy\n* Known allergic reaction to d-cycloserine, baclofen, memantine, or lorazepam",{"count":330,"type":21},80,[332],"EARLY_PHASE1","Many people with depression do not get better with standard treatments like medication. One promising alternative is transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic pulses to stimulate specific brain regions. A particular pattern of TMS called continuous theta-burst stimulation (cTBS) is thought to reduce overactive brain activity in depression, but the investigators do not yet fully understand how it works at the level of brain cells and connections.\n\nThis study aims to determine the biological mechanism by which cTBS changes brain activity in people with depression. Specifically, the investigators are testing two competing ideas: (1) that cTBS works by weakening the connections between brain cells through a process called long-term depression (LTD), which is driven by a chemical messenger system called glutamate; or (2) that cTBS works by increasing the brain's natural \"braking\" system, driven by a different chemical messenger called GABA.\n\nTo test these ideas, participants with depression will receive cTBS along with one of four FDA-approved medications, or placebo, that either boost or block these chemical messenger systems. The investigators will measure changes in brain activity using electroencephalography (EEG) recorded simultaneously with TMS. Specific patterns in the EEG signal, called TMS-evoked potentials (TEPs), act as a window into how different brain cell types are responding to stimulation.\n\nEach participant will complete four study visits, each testing a different drug-TMS combination in random order. One group of participants will test drugs targeting the glutamate system (d-cycloserine and memantine). A second group will test drugs targeting the GABA system (lorazepam and baclofen). All drugs are given as a single oral dose and are commonly used in clinical practice.\n\nUnderstanding exactly how cTBS works at a biological level could open the door to more effective, personalized TMS treatments.",[27],[276,277,336,30,337],"TMS-EEG","Pharmacologic Augmentation","2026-05-08",{"date":280,"type":40},{"date":341,"type":40},"2026-03-11",{"date":343,"type":21},"2030-12",{"name":287,"class":47},{"id":346,"slug":4,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":352,"maxAge":145,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":48},"100629813","NCT07479550","Study of Psilocybin Under Anesthesia Controlled by EEG","A Phase 2 Randomized Study Examining the Safety, Feasibility, and Effectiveness of Masking Psilocybin Therapy With General Anesthesia in Major Depressive Disorder","SPACE","INCLUSION CRITERIA:\n\nA participant will be eligible for inclusion when all of the following criteria are met:\n\n1. People 25 to 65 years of age at screening;\n2. Able to read, understand, and provide dated, informed consent, either in writing or electronically, prior to screening. Patients will be deemed likely to comply with study protocol and communicate with study staff about adverse events and other clinically important information;\n3. Fluent in English;\n4. Able to commit to attend all study visits and participate in all remote data collection procedures;\n5. Be stable in background psychotherapy for at least 4 weeks prior to enrollment outside of the study and able to access mental healthcare for the duration of the study;\n6. Body mass index between 17-35 kg\u002Fm2.\n7. Participant has a current diagnosis of MDD during a current Major Depressive Episode (MDE) (single or recurrent episode as defined by DSM-5-TR \\[if single episode, duration of ≥4 weeks\\] and verified after evaluation by a qualified member of the investigative team using the QuickSCID-5 (Quick Structured Clinical Interview for DSM-5 Disorders).\n8. Able to physically tolerate general anesthesia, as determined by American Society of Anesthesiologists (ASA) Physical Status Class I or II. ASA Class III participants whose functional impairment is directly related to a psychiatric diagnosis (depression) will be included.\n9. Agree that for one week preceding the psilocybin sessions and throughout the study, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study staff. Exceptions will be evaluated by the study staff and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n10. Agree not to consume any food or drink after midnight preceding dosing days.\n11. Agree not to consume alcoholic beverages for 48 hours prior to and 24 hours following the dosing sessions.\n12. Agree not to use cannabis in any form for the duration of the study.\n13. Non-smoker, or abstained at least 6 weeks.\n14. For people who can become pregnant: agree to use highly effective contraception from entry into the trial through the end of the study.\n\n    a. A person with a uterus is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterilized (i.e. has had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy).\n\n    b. A person with a uterus who is not of childbearing potential is considered to be postmenopausal after at least 12 months without menstruation.\n\n    c. Highly effective contraception (typical use failure rate of less than 1%) is defined i. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\n\u003C!-- -->\n\n1. oral\n2. intravaginal\n3. Transdermal\n4. Double-barrier method ii. progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n1\\. oral 2. injectable 3. implantable iii. intrauterine device (IUD) iv. intrauterine hormone-releasing system (IUS) v. bilateral tubal occlusion vi. vasectomized partner vii. sexual abstinence\n\nd. Periodic abstinence (i.e., calendar, symptothermal, or postovulation methods, and tubal ligation\u002Focclusion) are not an acceptable form of contraception for this study.\n\ne. The PI will use his judgement and familiarity with the participant's preferred and usual lifestyle to understand if reporting of abstinence may be trusted to achieve 100% effectiveness.\n\n15\\. Negative urinary pregnancy test at screening and again immediately before dosing sessions.\n\nEXCLUSION CRITERIA:\n\nA potential participant will NOT be eligible for participation in this study if any of the following criteria are met:\n\n1. Has any ongoing legal or disability claim such as Worker's Compensation\n2. Is taking a medication belonging to any of the following classes:\n\n   a. TCAs, MAOIs, SSRIs, SNRIs. (Other antidepressants including mirtazapine, nefazodone, trazodone, vilazodone, vortioxetine, and bupropion are allowed.) b. Typical or atypical antipsychotics c. Anticonvulsants such as valproate, topiramate, oxcarbazepine, carbamazepine. (Gabapentinoids and lamotrigine are allowed.) d. Other agents that may be associated with serotonin syndrome: i. St. John's Wort ii. S-adenosyl-methionine (SAM-e) iii. 5-Hydroxytryptophan (5-HTP) iv. Lithium v. Dextromethorphan vi. Linezolid vii. Buspirone viii. Efavirenz ix. Lorcaserin e. Agents that may interact with psilocybin metabolism\u002Feffects: i. Modulators of uridine diphosphate (UDP) or glucuronosyltransferase (UGT) (e.g., COMT inhibitors, ethinyl estradiol, valproate, diclofenac, mefenamic acid, verapamil, ketoconazole, itraconazole, probenecid, phenobarbital, protease inhibitors) ii. L-Methylfolate (\\>\u002F= 7.5mg\u002Fday) iii. Alcohol or aldehyde dehydrogenase inhibitors\n3. Is taking benzodiazepine medication such that patient cannot tolerate withholding doses 8 hours before through 6 hours after planned study intervention\n4. Is taking agents that may interact with psilocybin metabolism effects such that the patient cannot tolerate withholding doses 8 hours before through 6 hours after planned study intervention.\n5. For individuals who can become pregnant:\n\n   a. Currently pregnant (confirmed or suspected) b. Currently breastfeeding c. Positive urinary pregnancy test at screening or immediately before dosing d. Unwilling or unable to use highly effective contraception (defined as methods with failure rate \\\u003C1% per year) from the time of consent through 30 days following the last dosing session e. Planning to become pregnant within 30 days following the psilocybin or placebo administration sessions\n6. Participation in a clinical trial within 30 days of entry into this trial, or during the trial, or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, that may interfere with psilocybin metabolism\u002Feffects.\n7. Currently receiving electroconvulsive therapy (ECT). Previous treatment with ECT is permitted; last treatment must be at least 30 days prior to entry into this trial.\n8. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms, mania, or bipolar affective disorder\n9. A positive urine toxicology screen including amphetamines, cocaine, MDMA, cannabis, opioids, ketamine, and benzodiazepines at screening visit and on the morning of the dosing session.\n10. Use of psychedelics in the previous 6 months prior to screening (psilocybin, LSD, DMT, 5-Meo-DMT, MDMA, Ibogaine).\n11. History of meeting DSM-5 criteria for Hallucinogen Use Disorder (Moderate or Severe) or Hallucinogen Persisting Perception Disorder (HPPD),or has ever had a negative reaction to or experience with a psychedelic (e.g., \"bad trip\").\n12. Current diagnosis of a Substance Use Disorder over the last 12 months (SUD; Abuse or Dependence, as defined by DSM-V) per QuickSCID-5. Participants who are at risk of alcohol or cannabis withdrawal will be excluded (e.g. those who endorse tolerance or who have experienced previous withdrawal). The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or cannabis substance use disorder rated \"mild\".\n13. Current diagnosis of a psychiatric disorder or mental health status that in the judgement of the study staff increases the risk of the intervention or would interfere with the patient's ability to engage in the intervention at any time within the six months prior to screening.\n14. History of suicide attempt requiring hospitalization or suicidal ideation with intent in the last 10 years.\n15. In the judgment of the study staff, the participant is at significant risk for suicidal behavior during the course of their participation in the study per Columbia Suicide Severity Rating Scale (C-SSRS), rated 'High Risk'.\n16. A neurological disorder including:\n\n    1. Dementia, delirium, amnestic, or any other cognitive disorder.\n    2. Lifetime history of surgical procedures involving the brain or meninges,\n    3. Encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation\n    4. Any other disease\u002Fprocedure\u002Faccident\u002Fintervention associated with significant injury to or malfunction of the central nervous system (CNS),\n    5. History of significant head trauma within the past two years.\n17. A cardiovascular disorder including:\n\n    a. Elevated blood pressure defined as systolic blood pressure (SBP) \\>140 or diastolic blood pressure (DBP) \\>90 averaged over two separate measurements taken during the screening period b. Tachycardia defined as heart rate (HR) \\>90 beats per minute averaged over two separate measurements taken during the screening period c. Bradycardia defined as heart rate (HR) \\\u003C50 beats per minute averaged over two separate measurements taken during the screening period d. Angina e. Clinically significant EKG abnormality (e.g., atrial fibrillation, QTcF \\>450 ms for males or \\>470 ms for females) f. Any other significant current or history of a cardiovascular condition that would preclude safe participation in the study based on the clinical judgment of the investigators.\n18. Clinically significant pulmonary\u002Frespiratory disorder including\n\n    a. History of difficult airway or difficult mask ventilation, or predictors of difficult airway such as Mallampati Score 3 or 4, limited mouth opening, thyromental distance \\\u003C6cm, restricted neck mobility, or significant retrognathia.\n\n    b. COPD requiring systemic steroid use. c. Obstructive Sleep Apnea, moderate or severe (Apnea-Hypopnea Index \\>=15), or requiring regular CPAP use\n19. Clinically significant liver disease, determined by Liver Function Tests (LFTs) within the past 6 months: Hepatic dysfunction as indicated by any of the following values:\n\n    1. AST \\> 3 x upper limit of normal\n    2. ALT \\> 3 x upper limit of. Normal\n    3. Total bilirubin \\> 3.0 mg\u002Fdl\n20. Known allergy or hypersensitivity to propofol or any of its components (unless they have a documented propofol exposure without complication), including:\n\n    1. Eggs or egg products\n    2. Soybeans, soy products, or soy lecithin\n    3. Peanuts or other legumes\n    4. History of anaphylaxis, angioedema, bronchospasm, or other serious allergic reaction to any of the above substances.\n21. Known allergy or hypersensitivity to psilocybin or its metabolites.\n22. History of severe lipid disorder or recent pancreatitis\n23. Is taking a GLP-1 agonist class drug like tirzepatide, or has taken a dose within the past 7 days prior to propofol dosing.\n24. Has symptomatic gastroesophageal reflux disease, or other delayed gastric emptying conditions.\n25. Clinically significant kidney disease determined by creatinine\u002Fglomerular filtration rate within the past 6 months. Renal insufficiency (creatinine clearance \\\u003C 40 ml\u002Fmin using Cockraft and Gault equation)\n26. Any endocrine disorder or any thyroid disorder treated (medically or surgically) within the past 6 months prior to screening:\n\n    1. Uncontrolled diabetes, type 1 or 2 (well-controlled diabetes is allowed).\n    2. Hyperthyroidism or hypothyroidism diagnosed within the past six months prior to screening (stable treatment with a thyroid hormone replacement therapy is allowed).\n27. Other medical condition(s) or diagnosis, physical exam finding, EKG or laboratory abnormality that precludes participation in study procedures due to safety concerns at the discretion of the study staff.\n\n    \\-","25 Years",{"count":354,"type":21},10,[59],"Major depressive disorder (MDD) affects millions of Americans and remains difficult to treat. Psilocybin, a psychedelic compound, has shown promise for reducing depression symptoms, but a key challenge in psychedelic research is that participants can usually tell whether they received the active drug - making it hard to conduct fully blinded studies.\n\nThis study (Studying Psilocybin with Anesthesia Controlled by EEG \\[SPACE\\]) tests a new approach: administering psilocybin while participants are under general anesthesia, so that the noticeable psychological effects of psilocybin are masked. This allows both participants and outcome assessors to remain unaware of whether psilocybin or placebo was given, improving the scientific rigor of the research.\n\nParticipants with MDD will be randomly assigned to receive either psilocybin or placebo across four dosing sessions conducted under general anesthesia. The study will assess whether this approach is safe and feasible, and will collect early data on whether it may reduce depression symptoms.",[27],[239,68,359,360,361,362,363],"anesthesia","propofol","psychedelic-assisted therapy","blinding","masking",{"date":365,"type":40},"2026-05-06",{"date":367,"type":21},"2026-07",{"date":369,"type":21},"2027-08",{"name":168,"class":47},{"id":372,"slug":4,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":384,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":48},"100218563","NCT02122562","Ketamine Alcohol (in Treatment-Resistant Depression)","Functional Neuroimaging of the Enhanced Antidepressant Efficacy of Ketamine in a Biologically-Enriched Subgroup","INCLUSION CRITERIA:\n\n1. 18 to 55 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the consent quiz.\n3. Diagnostic and Statistical Manual-4th Edition-Text Revision (DSM-IV-TR)) diagnosis of major depressive disorder (MDD), single-episode (296.30) or recurrent (296.20) without psychotic features based on clinical assessment and confirmed by a Structured Clinical Interview for the DSM-IV- Patient Version (SCID-P). Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.\n4. Past failure of greater than or equal to one standard antidepressant trial based on the Antidepressant Treatment History Form (ATHF).\n5. MADRS score greater than or equal to 20 at baseline and the day of ketamine infusion.\n\nEXCLUSION CRITERIA:\n\n1. Inadequate knowledge of family mental and substance use history, e.g. adoption.\n2. Current psychotic features or prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, MDD with psychotic features, or bipolar disorder, e.g. bipolar I disorder without psychotic features, bipolar II disorder and bipolar disorder not otherwise specified (NOS).\n3. Current\u002Factive DSM-IV-TR substance use disorder (except for caffeine or nicotine dependence).\n4. Pregnant or nursing women or women of childbearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy).\n5. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper\u002Fhypothyroidism or active cancer.\n6. Presence of any medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n7. Clinically significant abnormal laboratory tests.\n8. Subjects with one or more seizures without clear and resolved etiology and head injury with loss of consciousness for \\> 5 minutes or requiring hospitalization.\n9. Treatment with psychiatric medications, e.g. selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, benzodiazepines and antipsychotics, at least two weeks of study phase II.\n10. Treatment with fluoxetine within 5 weeks of study phase II.\n11. Treatment with device-based treatment for depression, e.g. electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) and vagal nerve stimulation (VNS), within 4 weeks of study phase II.\n12. Lifetime history of deep brain stimulation.\n13. Treatment with any disallowed concomitant medications.\n14. Positive HIV test\n15. Presence of ferromagnetic implants, e.g, heart pacemaker or aneurysm clip, or other contraindications to magnetic resonance imaging (MRI), e.g. claustrophobia or hearing loss.\n16. Clinically-significant anatomical brain abnormalities detected on routine brain MRI.\n17. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of greater than or equal to 4.\n18. A current NIMH employee\u002Fstaff or their immediate family member (N.B. former exclusion criteria likely to be no longer relevant at the University of Iowa Health Care).\n19. Currently engaged in an evidence-based structured psychotherapy for mood and\u002For anxiety disorders, e.g. cognitive-behavioral therapy (CBT) or interpersonal psychotherapy (IPT).\n\nAdditionally, the investigators may exclude or terminate any patient for clinical reasons.",{"count":378,"type":21},60,[59],"A single subanesthetic dose infusion of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has rapid and robust antidepressant effects in patients with treatment-refractory major depressive disorder (TRD). A family history of an alcohol use disorder (Family History Positive, FHP) is one of the strongest identified predictors of an improved antidepressant response to ketamine. Like ketamine, alcohol is a functional NMDA receptor antagonist. FHP is associated with differential response to ketamine, e.g. blunted psychotomimetic side effects. One of the primary mechanistic hypotheses for ketamine's antidepressant action is the acute intrasynaptic release of glutamate from major output neurons, e.g. cortical pyramidal cells. Preliminary clinical studies have demonstrated this acute glutamate \"surge\" in response to subanesthetic dose ketamine. Based on these findings, the investigators hypothesize that ketamine's enhanced antidepressant efficacy in FHP TRD subjects is, at least in part, attributable to increased glutamate release relative to TRD subjects without a family history of alcohol use disorder (Family History Negative, FHN). To test this hypothesis, the investigators have designed a now two-site, open-label study of 18-55-year-old medically and neurologically healthy, currently moderately-to-severely depressed TRD patients. In total, the investigators plan to recruit 25 FHP and 25 FHN TRD subjects. All subjects must not have a current substance use disorder (except nicotine or caffeine). The experimental portion consists of two phases. The preliminary first phase is a medication taper (if needed) and psychotropic medication-free period. The experimental second phase comprises one subanesthetic dose (0.5mg\u002Fkg x 40 minute) ketamine infusion. The ketamine infusion will occur during 7T-magnetic resonance imaging (MRI), both resting-state functional MRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) to detect glutamate in the ventromedial prefrontal cortex\u002Fventral anterior cingulate cortex (vmPFC\u002FvACC). The primary outcome measure is group mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from pre-ketamine infusion (baseline) to one-week post-infusion, where the investigators observed ketamine's greatest antidepressant effect in FHP TRD. Additional outcome measures are vmPFC\u002FvACC glutamate change in response to ketamine based on family history status. In summary, this study will provide key mechanistic information on ketamine's improved antidepressant efficacy in a biologically-enriched subgroup. This will contribute to the systematic development of more efficacious, personalized treatments for major depression in an effort to reduce its enormous public health burden.",[382,27,383],"Magnetic Resonance Imaging","Alcoholism",[385,27,386],"Ketamine","NMDA Antagonist","2026-04-27",{"date":308,"type":40},{"date":390,"type":4},"2014-04-23",{"date":392,"type":21},"2028-09",{"name":394,"class":47},"Mark Niciu",{"id":396,"slug":4,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":401,"maxAge":18,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":408,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":417,"leadSponsor":419,"locationsCount":48},"100631616","NCT07503002","Shortened LSD Intervention for Major Depressive Disorder","SLIM","Inclusion Criteria:\n\n* Have given written informed consent\n* Meet DSM-5 criteria for MDD\n* MADRS \\>= 28 at screening Can read, write, and speak English fluently\n* Be judged by study team clinicians to be at low risk for suicidality\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing, or not practicing an effective means of birth control\n* Cardiovascular conditions: hypertension with resting blood pressure systolic \\>139 or diastolic \\>89, angina, heart rate \\> 99, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc \\> 450), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease, cardiac valvulopathy\n* Epilepsy\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Currently taking antipsychotics, or MAO inhibitors\n* Patients taking antidepressant medications and unable to taper\n* Moderate or strong CYP2D6 inhibitor antidepressants must undergo a washout period of 4 weeks or five half-lives prior to treatment\n* Currently taking CYP2D6 inhibitor other than an antidepressant that will be tapered\n* Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag\n* Have a seizure disorder, multiple sclerosis, history of significant head trauma, CNS tumor, movement disorders or any neurodegenerative condition\n* Morbidly obese (\\>100 lbs. above ideal body weight, or BMI \\>=40, or BMI \\>=35 with high blood pressure or diabetes)\n* Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal\n* Body weight \\\u003C 45 kg\n* Significant acute adverse reaction (e.g., dystonia) to an antipsychotic\n* Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (including substance-induced), Bipolar I or II Disorder or Major\n* Depression with psychotic features\n* Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or Bipolar I Disorder.","21 Years",{"count":354,"type":21},[205],"The purpose of this study is to determine the safety and clinical effectiveness of a shortened lysergic acid diethylamide (LSD) experience. This will be achieved by administering the drug risperidone 45-minutes after the administration of LSD.",[406,407,27],"Major Depression Moderate","Major Depression Severe",[409,410,238,62,411,412],"LSD","lysergic acid diethylamide","major depression","major depressive","2026-03-30",{"date":415,"type":40},"2026-04-03",{"date":284,"type":21},{"date":418,"type":21},"2027-12-01",{"name":420,"class":47},"Johns Hopkins University",{"id":422,"slug":4,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":426,"enrollmentInfo":427,"targetDuration":429,"studyType":125,"phases":4,"briefSummary":430,"conditions":431,"keywords":436,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":48},"100399417","NCT04480918","University of Iowa Interventional Psychiatry Service Patient Registry","INCLUSION CRITERIA:\n\n1. 18-99 years of age\n2. English-speaker with a level of understanding sufficient to agree to clinical treatment with a treatment modality offered by the Interventional Psychiatry Service, all required research procedures, and sign an informed consent document\n3. Clinical diagnosis of a major depressive episode in the context of major depressive disorder or bipolar disorder or treatment-resistant OCD evaluated by a provider on the Interventional Psychiatry Service and felt to be an appropriate candidate for clinical treatment with a treatment modality offered by the Interventional Psychiatry Service.\n\nEXCLUSION CRITERIA:\n\n1. Age less than 18 years\n2. A primary neuropsychiatric diagnosis that is not either major depressive disorder or bipolar disorder\n3. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper\u002Fhypothyroidism or active cancer.\n4. Involuntary commitment to psychiatry inpatient units\n5. If patients have one or more of the following MRI Exclusion criteria, they will not be able to participate in those aspects of this study:\n\n   1. The presence of an implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible\n   2. The presence of ferromagnetic objects in the body, i.e. bullets, shrapnel, and\u002For metal slivers\n   3. Clinically-significant claustrophobia\n   4. Clinically-significant hearing loss\n   5. Pregnant or nursing women or women of child bearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence, or partner with vasectomy)\n   6. The presence of any medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications","99 Years",{"count":428,"type":21},1000,"2 Months","The purpose of this study is to examine the effects of interventional\u002Fprocedural therapies for treatment-resistant depression (TRD) and Obsessive-Compulsive Disorder (OCD). These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion and intranasal esketamine insufflation. The investigators will obtain various indicators, or biomarkers, of a depressed individuals' state before, during, and\u002For after these treatments. Such biomarkers include neurobehavioral testing, neuroimaging, electroencephalography, cognitive testing, vocal recordings, epi\u002Fgenetic testing, and autonomic nervous system measures (i.e. \"fight-or-flight\" response). The results obtained from this study may provide novel antidepressant treatment response biomarkers, with the future goal of targeting a given treatment to an individual patient (\"personalized medicine\").",[432,433,27,208,179,434,435],"Treatment Resistant Depression","Major Depressive Episode","Bipolar Depression","Obsessive-Compulsive Disorder",[437,101,385,438],"Electroconvulsive Therapy","Esketamine","2026-02-27",{"date":441,"type":40},"2026-03-03",{"date":443,"type":40},"2020-11-02",{"date":445,"type":21},"2050-08",{"name":394,"class":47},{"id":448,"slug":4,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":91,"sex":16,"minAge":17,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":48},"100572362","NCT06732284","Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task","IN-DEP","Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* Ability to understand, write and read French Inclusion criteria for patients with major depression\n* Diagnosis of depression according to DSM-5 criteria\n* Suspicion of a sleep disorder requiring polysomnographic screening\n* Score for IHSS items 3 and 4\n\n  * Score ≥ 1 for group with sleep inertia\n  * Score = 0 for the group without sleep inertia Inclusion criteria for controls\n* No complaints of sleep inertia (score = 0 on IHSS items 3 and 4)\n* No excessive daytime sleepiness (Epworth Sleepiness Scale score ≤10),\n* No depressive symptoms (Hospital Anxiety Depression Scale score \\\u003C 8 on items 2, 4, 6, 8, 10, 12, 14).\n\nExclusion Criteria:\n\n* The patient is participating in an interventional study\n* The patient is under safeguard of justice or state guardianship\n* Unweaned from the following medications for at least 5 half-lives prior to inclusion: wake-promoting or psychostimulant drugs (modafinil, methylphenidate, mazindol, amphetamine, pitolisant, solriamfetol, sodium oxybate), neuroleptics, hypnotics, antidepressants, anxiolytics, antiepileptics, budipine, dopamine agonist and antagonist antiemetics (except domperidone), opiates, gabapentin, pregabalin, benzodiazepines, Z-hypnotics (zolpidem and zopiclone), monoamine oxidase inhibitors, catechol-O-methyltransferase or sedative antihistamines.\n* Patients with central nervous system diseases: Parkinson's disease, mild cognitive impairment and dementia, progressive supranuclear palsy, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, epilepsy, history of head trauma with loss of consciousness.\n* Patients with a malignant neoplastic disease requiring therapeutic treatment in the 12months prior to the screening visit\n* Other medical or psychiatric illnesses (with the exception of depression in he depression group) which, in the investigator's opinion, could interfere with the study.\n* History of suicide attempt (including failed attempt), or suicidal ideation in the past month\n* Chronic alcohol consumption or drug abuse in the previous 6 months\n* Sleep-wake circadian rhythm disorders and presence of sleep insufficiency according to ICSD-3 criteria\n* Pregnant, parturient or breast-feeding women.","54 Years",{"count":455,"type":21},110,"The study population comprises three groups of 30 analyzable participants: Patients with sleep inertia and Major Depressive Disorder, patients with Major Depressive Disorder but without sleep inertia, and controls without mood disorders or sleep inertia. Controls will be patients referred to the Sleep Disorders and Acupuncture Unit for polysomnography as part of the screening process for a sleep disorder. Only controls presenting an apnea-hypopnea index \\\u003C 15\u002Fh, a periodic leg movements index during sleep \\\u003C 15\u002Fh and a total sleep time ≥ 6 hours on the video-polysomnography will be analyzed.",[27,458],"Sleep Inertia",[460],"psychomotor vigilance task","2025-12-04",{"date":463,"type":40},"2025-12-11",{"date":465,"type":40},"2025-11-04",{"date":467,"type":21},"2027-03",{"name":469,"class":47},"Centre Hospitalier Universitaire de Nīmes",{"id":471,"slug":4,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":479,"conditions":480,"keywords":482,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100242446","NCT02434393","Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project","Characterizing Cognitive Decline in Late Life Depression: The Alzheimer's Disease Neuroimaging Initiative - Depression Project","ADNI-D","Inclusion Criteria:\n\n1\\. Individual participated in original Characterizing Cognitive Decline in Late Life Depression study or Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression Study.\n\nExclusion Exceptions:\n\n1. Antidepressant medication treatment is allowed only if the medication dose is stable for 4 weeks prior to the MRI scan.\n2. Psychotherapy interventions is allowed only if they have completed at least 4 weeks of individual or group psychotherapy intervention prior to the MRI scan.\n3. Participants taking cognitive enhancing medications will be able to enter the study.",{"count":478,"type":21},120,"The purpose of this research study is to characterize the mechanisms contributing to cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD).\n\nThis is a non-randomized, observational, non-treatment study that originally launched in 2015, enrolling 133 participants. From the originally enrolled participants, the continuation of the ADNI-D study will enroll 120 participants which will include following participants from the original (parent) protocol and enrollment of new participants for a period of 30 months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for comparison.\n\nDepression history, symptom severity and health information will be collected at the initial visit to determine eligibility. An magnetic resonance imaging (MRI) scan, as well as amyloid (florbetapir) and tau (flortaucipr) positron emission tomography (PET) imaging will be conducted at San Francisco VA. Collection of plasma and serum for biomarkers, clinical assessments and cognitive assessments will be conducted at two time points. Blood samples will also be collected for genetic analysis.",[27,481],"Late Life Depression (LLD)",[30,483,484,485,486],"Late Life Depression","LLD","amyloid imaging","biomarkers","2025-11-21",{"date":489,"type":40},"2025-11-25",{"date":491,"type":40},"2015-03-04",{"date":493,"type":21},"2027-05",{"name":495,"class":47},"University of Southern California",2,{"id":498,"slug":4,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":145,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":512,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":48},"100595389","NCT07031817","Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder","Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder in Patients With a Characterized Depressive Episode in Primary Care","BIPOVITE","Inclusion Criteria :\n\n* Cis man, cis woman, trans man, trans woman or non-binary,\n* Aged 18 to 65 years old,\n* Meets the DSM-5 criteria for the diagnosis of moderate to severe EDC and is eligible for antidepressant treatment.\n\nNon-Inclusion Criteria :\n\n* Patients under guardianship or trusteeship,\n* Patients with schizophrenia according to DSM-5 criteria,\n* Patients who have received psychotropic treatment in the 5 days prior to inclusion (or 21 days for fluoxetine or aripiprazole), with the exception of benzodiazepines and hydroxyzine at the doses and in compliance with the indications of the Marketing Authorisations,\n* Patients with an unstable physiological state or a serious and symptomatic medical condition in the opinion of the investigator,\n* Pregnant or breast-feeding patients,\n* Patients with a known autoimmune disease, in particular Crohn's disease or thyroiditis, or any other pathology which could, in the opinion of the investigator, modify the blood concentration of immune biomarkers,\n* Patients unable to give informed consent to participate in the study or who cannot be given informed information,\n* Patients not covered by a social security scheme,\n* Patients participating in another interventional study on the day of inclusion,\n* Patients under court protection,\n* Patients vaccinated less than 30 days ago,\n* Patients with difficulties reading, understanding or speaking French.\n\nExclusion Criteria :\n\n* Participants will have the right to withdraw their consent at any time for any reason whatsoever without any prejudice to them,\n* The investigator may prematurely exclude a subject from the study, in agreement with the sponsor, if the subject presents one or more exclusion criteria,\n* Diagnosis of schizophrenia during follow-up or any other diagnosis that would lead to a change in the initial EDC diagnosis,\n* Any condition or situation which, in the opinion of the investigator, would be incompatible with the continuation of the study or which would lead to a bias in the management of the data.",{"count":505,"type":21},623,[24],"The goal of this interventional clinical trial is to assess the diagnostic performance of a composite diagnostic medical devise based on blood-based in vitro diagnostic device and Mood Disorder Questionnaire (MDQ) in identifying bipolar disorder among adult patients presenting with a current major depressive episode in primary care. The study will compare the results of the medical device diagnostic test to those of standardized psychiatric clinical evaluation, to evaluate its sensitivity, specificity, and overall clinical utility.\n\nThe main research questions are :\n\n* Can the investigational medical device accurately distinguish bipolar disorder from unipolar depression ?\n* How does its diagnostic accuracy compare with validated psychiatric questionnaires commonly used in clinical practice ?\n\nParticipants will :\n\n* Provide a blood sample for biomarker analysis using the investigational diagnostic device.\n* Complete a few validated psychiatric assessment tools (e.g., MDQ, MINI).\n* Share sociodemographic and clinical data relevant to psychiatric evaluation.",[509,510,511,27],"Bipolar Disorder (BD)","Major Depressive Episode (MDE)","Primary Care",[513,514,515,516,517,518,519,520,521,522],"bipolar disorder","major depressive episode","primary care","composite medical device","blood biomarkers","mood depression questionnaire","diagnosis","composite diagnostic tool","in vitro diagnostic test","blood biomarker-based algorithm","2025-10-02",{"date":525,"type":40},"2025-10-07",{"date":527,"type":40},"2025-09-30",{"date":529,"type":21},"2028-07-01",{"name":531,"class":47},"University Hospital, Montpellier",{"id":533,"slug":4,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":48},"100597768","NCT07062783","Effect of Aerobic Exercise on Biomarkers in Depression","The Effect of Respiratory and Aerobic Exercises on Neuroprotective and Inflammation Biomarkers in Patients Diagnosed With Major Depression","Inclusion Criteria:\n\n* Individuals who volunteer to participate in the study,\n* Between the ages of 18 and 40,\n* Have been diagnosed with clinical depression by a psychiatrist according to DSM-5 criteria\n\nExclusion Criteria:\n\n* Individuals with chronic conditions accompanying depression,\n* Those with walking difficulties\n* Those with respiratory system disorders","40 Years",{"count":540,"type":21},40,[24],"This study aims to investigate changes in the levels of biomarkers (IGF-1, FGF2, and EGF) involved in neuron development in patients diagnosed with major depression through the effects of breathing exercises and aerobic exercise, as well as to examine the levels of biomarkers (TNF-α, IL-6, and IL-1) and oxidative stress (TAS, TOS, MDA, and F2-isoprostane) that are thought to play a role in the pathophysiology of depression.",[27],[30,545,546,547],"Aerobic exercise","Oxidative stress","Growth factors","2025-09-04",{"date":550,"type":40},"2025-09-05",{"date":552,"type":40},"2024-08-01",{"date":527,"type":21},{"name":555,"class":47},"Kutahya Health Sciences University",{"id":557,"slug":4,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":16,"minAge":563,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":567,"conditions":568,"keywords":572,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":496},"100574730","NCT06763081","Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation","Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)","PGx-SImBA","Inclusion criteria: Participants will be eligible for participation if all of the following are true.\n\n* Resident of Manitoba\n* Age, 6 - 24 years\n* Diagnosis of major depressive disorder (MDD), anxiety disorder, or obsessive-compulsive disorder (OCD)\n* Current or past history of selective serotonin reuptake inhibitor (SSRI), e.g., Citalopram \\[Celexa\\], Escitalopram \\[Cipralex\\], Fluoxetine \\[Prozac\\], Fluvoxamine \\[Luvox\\], Sertraline \\[Zoloft\\], Paroxetine \\[Paxil\u002FPlaxil CR\\]) therapy\n* \\[Cases Only\\] Have experienced behavioural side effects after taking an SSRI that resolved after reducing the dose or discontinuation of the drug\n* \\[Controls Only\\] Did not experience any side effects after taking an SSRI for eight (8) continuous weeks\n\nExclusion criteria: Participants will be excluded from participation if any of the following are true.\n\n* Inability of parent\u002Flegal guardian\u002Fmature minors to give informed consent\n* Inability of the child (6 - 13 years) to give informed assent\n* Unwillingness of the child to provide a saliva sample for genetic analysis\n* Current, past, or suspected diagnosis of attention deficit hyperactivity disorder (combined or hyperactive type), oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, pervasive developmental disorder\n* History of liver or bone marrow (hematopoietic cell) transplant.","6 Years","24 Years",{"count":566,"type":21},160,"The purpose of this study is to identify and validate a panel of genetic markers associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioural activation in children and youth with major depressive disorder (MDD), anxiety disorders, or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.",[569,208,570,571,130,27],"Behavioral Activation","Anxiety Disorders","Antidepressant Drug Adverse Reaction",[573,30,574,575,576,577,578,182,579,580,581,582,583,584,585],"SSRI","OCD","Anxiety","Antidepressants","Children","Adolescents","Drug-induced Adverse Events","Youth","Mental Illness","Mental disorders","Drug-Related Side Effects and Adverse Reactions","Selective Serotonin Reuptake Inhibitor","Disinhibition","2025-09-01",{"date":588,"type":40},"2025-09-08",{"date":590,"type":40},"2025-03-01",{"date":592,"type":21},"2030-12-31",{"name":594,"class":47},"University of Manitoba",{"id":596,"slug":4,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":11,"sex":601,"minAge":17,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":496},"100446757","NCT05097586","RCT of At-Home tDCS for Depression in Pregnancy","Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy","Inclusion criteria:\n\n1. Adult, ≥18 years of age\n2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization\n3. In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)\n4. Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use\n5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment\n\nExclusion criteria:\n\n1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS\n2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)\n3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview\n4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview\n5. Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia\u002Feclampsia in current pregnancy or neurologic illness or seizure history\n6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI\u002FCo-I assessment)\n7. Metal implants in cranium or any electrical implants\n8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS\n9. Visibly non-intact skin\u002Frash on scalp areas at stimulation electrode sites\n10. Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English","FEMALE",{"count":603,"type":21},156,[24],"This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum",[27,607,608],"Pregnancy","Postpartum Depression",[607,30,610],"Transcranial direct current stimulation","2025-05-21",{"date":613,"type":40},"2025-05-28",{"date":615,"type":40},"2021-11-08",{"date":617,"type":21},"2027-06",{"name":619,"class":47},"Women's College Hospital",{"id":621,"slug":4,"hasResults":11,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":11,"sex":16,"minAge":627,"maxAge":401,"enrollmentInfo":628,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":496},"100207670","NCT01980147","Skills for Wellness","Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth","SWELL","Inclusion Criteria:\n\n* FORBOW (Families Overcoming Risks and Building Opportunities for Well-Being) participant between 9-21 years old\n* Meet criteria for one or more antecedents (psychotic like experience, basic symptoms, anxiety or affective lability)\n\nExclusion Criteria:\n\n* Diagnosis of severe mental illness (schizophrenia, other psychotic disorder, bipolar disorder, severe major depressive disorder)\n* More than 3 sessions of structured psychological therapy in the past 12 months\n* Insufficient understanding of the English language to benefit from the intervention","9 Years",{"count":629,"type":21},360,[24],"Severe mental illness such as schizophrenia and mood disorders typically develops at a young age and can cause life-long disability. Currently available treatments cannot cure severe mental illness. This makes it important to find ways to prevent severe mental illness in young people before it has a chance to develop. This research study will pilot a new preventive intervention for young people who are at high risk of developing severe mental illness. The investigators will target early preceding factors (the 'antecedents') to severe mental illness which includes anxiety, unusual hearing and visual experiences, the loss of previously acquired abilities, and sudden and unpredictable changes in mood. These antecedents strongly predict an increased risk of developing severe mental illness. They are often impairing and distressing to the individual but can be improved with self-management skills and parent training, and they are present in the individual years before the onset of severe mental illness which makes them an ideal target for early intervention. The goal is to intervene early enough in the young person's life that severe mental illness can be prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators want to test the acceptability and short-term efficacy of this new preventive intervention.",[633,179,27],"Schizophrenia",[635],"Severe Mental Illness","2025-05-13",{"date":638,"type":40},"2025-05-14",{"date":640,"type":40},"2014-03-22",{"date":642,"type":21},"2028-06-30",{"name":644,"class":47},"Nova Scotia Health Authority",{"id":646,"slug":4,"hasResults":11,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":22,"phases":654,"briefSummary":655,"conditions":656,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":496},"100576153","NCT06781593","Combining Light Therapy and CPAP in Depression","Effects of Light Therapy on Compliance With Continuous Positive Airway Pressure in a Population of Depressed Patients Newly Fitted With Devices for Obstructive Sleep Apnea","LUCIOPRESS","Inclusion Criteria:\n\n* Adults consulting at the MICHEL JOUVET unit, CH Le Vinatier, Bron\n* Adults with a diagnosis of major depressive episode (DSM-V) and with a MADRS score ≥ 15\n* Adults with a diagnosis of OSAS on ventilatory polygraphy or polysomnography (AASM 2017 criteria) requiring CPAP.\n\nExclusion Criteria:\n\n* Refusal to participate.\n* Pregnant and breast-feeding women\n* Under guardianship or curatorship.\n* Unstable psychiatric or physical pathology (e.g., hypomania, high suicidal risk) considered incompatible with the study by the investigators.\n* Other psychiatric, neurologic or somatic conditions\n* Contraindication to light therapy: retinopathy, retinitis pigmentosa, diabetic retinopathy, macular degeneration, glaucoma, recent eye surgery (less than 3 months).\n\npatient wishing to choose a provider other than the protocol provider.\n\n* Patient wishing to choose a device other than SEFAM's S-BOX or a mask other than the nasal mask at the time of introduction.\n* Nasal obstruction.\n* Refusal to use actimetry, refusal to use light therapy, refusal to use CPAP.",{"count":653,"type":21},130,[24],"In a double-blind, parallel-group controlled trial, we aim to measure the effect of two weeks of light therapy combined with the CPAP on compliance CPAP in patients with major depressive disorder.",[27,657,658,659,660,661],"Sleep Architecture","Obstructive Sleep Apnea","Compliance","Continuous Positive Airway Pressure (CPAP)","Light Therapy","2025-04-24",{"date":664,"type":40},"2025-04-29",{"date":666,"type":40},"2025-01-17",{"date":668,"type":21},"2027-10-30",{"name":670,"class":47},"Hôpital le Vinatier",""]