[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487736":3},{"organization":4,"outcomesModule":7,"designInfo":92,"detailedDescription":95,"studyPopulation":96,"armGroups":97,"interventions":112,"overallOfficials":123,"centralContacts":127,"locations":137,"responsibleParty":155,"collaborators":158,"id":162,"slug":91,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":91,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":91,"studyType":174,"phases":91,"briefSummary":175,"conditions":176,"keywords":91,"overallStatus":140,"whyStopped":91,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Mclean Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":91},[9,13,16,20,23,26,29],{"measure":10,"description":11,"timeFrame":12},"Clinical Interview","For assessing psychological state","Baseline",{"measure":14,"description":15,"timeFrame":12},"Behavioral Performance on the Probabilistic Reward Task (PRT)","the PRT assesses individuals' ability to learn from rewards",{"measure":17,"description":18,"timeFrame":19},"MRI Data","For testing the neural correlates of approach-avoidance decision making behaviors","within 30 days of Screening Visit",{"measure":21,"description":22,"timeFrame":12},"Salivary Cortisol","For assessing stress level",{"measure":24,"description":25,"timeFrame":19},"PET Data","For assessing the Nociceptin\u002FOprhanin FQ receptor system activity",{"measure":27,"description":28,"timeFrame":12},"Arterial blood data","for PET modeling and assessing Nociceptin\u002FOrphanin FQ levels in bloodstream",{"measure":30,"description":31,"timeFrame":32},"Follow-up Clinical Interviews","To assess psychological state changes","Change from Baseline at 6 months and 12 months after the PET visit",[34,37,40,43,46,49,52,55,58,61,64,67,70,73,76,79,82,84,87],{"measure":35,"description":36,"timeFrame":32},"Beck Depression Inventory-II (BDI)","self-report measure of depressive symptoms",{"measure":38,"description":39,"timeFrame":12},"Childhood Trauma Questionnaire (CTQ)","self-report measure of childhood trauma",{"measure":41,"description":42,"timeFrame":32},"Medical Outcome Survey-Short form (SF-36)","self-report with subscales measuring physical functioning, physical role functioning, social functioning, etc.",{"measure":44,"description":45,"timeFrame":32},"Perceived Stress Scale (PSS)","self-report measure of stress levels",{"measure":47,"description":48,"timeFrame":12},"Positive and Negative Affect Schedule (PANAS)","self-report measure of positive and negative affect",{"measure":50,"description":51,"timeFrame":32},"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)","self-report measure of satisfaction and enjoyment across domains (e.g., work, leisure, social relations)",{"measure":53,"description":54,"timeFrame":32},"Snaith Hamilton Pleasure Scale (SHAPS)","self-report measure of pleasure",{"measure":56,"description":57,"timeFrame":12},"Thought and Feeling Questionnaire (TFQ)","self-report measure of perception of being stuck in difficult situations",{"measure":59,"description":60,"timeFrame":12},"Defeat Scale (DS)","self-report measure of perception of defeat",{"measure":62,"description":63,"timeFrame":32},"Questionnaire of Unpredictability in Childhood (QUIC)","self-report measure of unpredictability of parental environment growing up",{"measure":65,"description":66,"timeFrame":12},"Mood and Anxiety Symptom Questionnaire (MASQ)","self-report measure of mood symptom severity including 4 subscales related to depression and anxiety",{"measure":68,"description":69,"timeFrame":12},"State-Trait Anxiety Inventory (STAI)","Measures and differentiates between anxiety",{"measure":71,"description":72,"timeFrame":12},"PRT Post-task Questionnaire","self-report measure of participants' thoughts regarding the PRT task stimuli",{"measure":74,"description":75,"timeFrame":32},"Temporal Experience of Pleasure Scale (TEPS)","self-report measure of ability to want and enjoy rewards",{"measure":77,"description":78,"timeFrame":12},"Columbia-Suicide Severity Rating Scale (C-SSRS)","clinical measure of suicidality",{"measure":80,"description":81,"timeFrame":32},"Hamilton-Depression Rating Scale (HAMD-17)","clinical measure of depression severity",{"measure":83,"description":81,"timeFrame":32},"Quick Inventory of Depressive Symptomatology (QIDS)",{"measure":85,"description":86,"timeFrame":12},"Cognitive-Behavioral Avoidance Scale (CBAS)","self-report measure of trait avoidance",{"measure":88,"description":89,"timeFrame":90},"Stress and Adversity Inventory (STRAIN)","self-report measure of lifetime exposure to acute and chronic stress that may affect mental and physical health","Change from Baseline at 12 months after the PET visit",null,{"allocation":91,"interventionModel":91,"interventionModelDescription":91,"primaryPurpose":91,"observationalModel":93,"timePerspective":94,"maskingInfo":91},"CASE_CONTROL","PROSPECTIVE","The overarching goals of this research are to investigate: (1) the activity of the Nociceptin\u002FOrphanin FQ receptor system among individuals with current or remitted MDD; (2) neural foundations of approach\u002Favoidance behaviors in current or remitted MDDs; (3) stress-induced inflammation in individuals with remitted MDD; (4) neural markers that predict future disease course.\n\nThis will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach\u002Favoidance decision-making task, in addition to a resting positron emission tomography (PET) scan.","The subjects for this research will be 228 participants recruited from the community by the Center for Depression, Anxiety and Stress Research (Director: Dr. Diego Pizzagalli, Ph.D.). Demographically-matched participants will include: (1) 38 participants with current MDD; (2) 38 participants with past MDD; and (3) 38 healthy controls.",[98,104,108],{"label":99,"type":91,"description":100,"interventionNames":101},"MDD subjects","Subjects diagnosed with Major Depression Disorder",[102,103],"Device: Aversive stimuli","Drug: PET radiotracer",{"label":105,"type":91,"description":106,"interventionNames":107},"Remitted MDD subjects","Subjects with a history of major depressive disorder episode in the past",[102,103],{"label":109,"type":91,"description":110,"interventionNames":111},"Control subjects","Subjects with no history of known neurological and psychiatric illness.",[102,103],[113,118],{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":91},"DEVICE","Aversive stimuli","Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).",[109,99,105],{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":91},"DRUG","PET radiotracer","A Nociceptin\u002FOrphanin FQ (\"N\u002FOFQ\") peptide tracer (\\[11C\\] NOP-1A) will be used as the PET radiotracer. Approximately 10 mCi of this tracer will be delivered intravenously as a slow bolus over 60 seconds with beginning of the PET imaging acquisition. Approximately 60 ml of blood will be drawn from an artery throughout the dynamic PET acquisition in order to measure the blood N\u002FOFQ levels.",[109,99,105],[124],{"name":125,"affiliation":5,"role":126},"Diego Pizzagalli, PhD","PRINCIPAL_INVESTIGATOR",[128,133],{"name":129,"role":130,"phone":131,"phoneExt":91,"email":132},"Tracy Lam, BS","CONTACT","617-855-4437","mclrew41study@mgb.org",{"name":134,"role":130,"phone":135,"phoneExt":91,"email":136},"David Crowley, ALM","617-855-4432","djcrowley@mclean.harvard.edu",[138],{"facility":139,"status":140,"city":141,"state":142,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":151,"contacts":152},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":147,"coordinates":148},"Point",[149,150],-71.17867,42.39593,{"lat":150,"lon":149},[153],{"name":129,"role":130,"phone":131,"phoneExt":91,"email":154},"clam@mclean.harvard.edu",{"type":126,"investigatorFullName":156,"investigatorTitle":157,"investigatorAffiliation":5,"oldNameTitle":91,"oldOrganization":91},"Diego Pizzagalli","Director, Center for Depression, Anxiety and Stress Research",[159],{"name":160,"class":161},"National Institute of Mental Health (NIMH)","NIH","100487736",false,"NCT05630963","Beyond Monoamines: The Role of the Nociceptin\u002FOrphanin FQ Receptor in Major Depression","Inclusion Criteria for all participants:\n\n* All genders, races, and ethnic origins, aged between 18 and 45\n* Capable of providing written informed consent, and fluent in English\n* Right-handed\n* Absence of any psychotropic medications for at least 2 weeks\n* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)\n\nInclusion Criteria for \"Remitted MDD\" group:\n\n* Meets inclusion criteria for all subjects, plus:\n* History of MDD as defined by DSM-5\n* Absence of anxiety disorder for the past two months\n\nInclusion Criteria for \"Current MDD\" group:\n\n* Meets inclusion criteria for all subjects, plus:\n* Presence of MDD as defined by DSM-5\n* Absence of anxiety disorder for the past two months\n\nExclusion Criteria for all participants:\n\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment\n* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s\u002Fp tubal ligation, or partner with vasectomy)\n* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease\n* History of seizure disorder\n* History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups\n* History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance\u002Falcohol use disorder only if it ended as least 12 months ago\n* History of cocaine or stimulant use or dopaminergic drugs\n* History or current diagnosis of dementia, or a score of \\\u003C 26 on the Mini Mental State Examination at the screening visit;\n* Patients with mood congruent or mood incongruent psychotic features\n* Current use of other psychotropic drugs\n* Clinical or laboratory evidence of hypothyroidism\n* Patients with a lifetime history of electroconvulsive therapy (ECT)\n* Failure to meet standard MRI safety requirements\n* Abnormal ECG and lab results\n* History of seizure disorder\n* Contraindications for arterial line (e.g., abnormal result on Allen test, Raynaud's syndrome, history of anemia or bleeding disorder, history of fainting from blood draws).",true,"ALL","18 Years","45 Years",{"count":172,"type":173},228,"ESTIMATED","OBSERVATIONAL","This study looks at the role of the Nociceptin\u002FOrphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.",[177],"Major Depressive Disorder","2025-10-17",{"date":180,"type":181},"2025-10-21","ACTUAL",{"date":183,"type":181},"2021-12-29",{"date":185,"type":173},"2027-02-28",{"name":5,"class":6},1]