[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-and-schizophrenia-spectrum-psychosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-and-schizophrenia-spectrum-psychosis":152},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,86,126],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100588260",false,"NCT06939088","Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder","Effect of Tirzepatide on Alcohol Intake and Reward Processing in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder","DUALPSYCHIATRY","Inclusion Criteria:\n\n* Informed Consent: The patient must provide both oral and written informed consent.\n* Diagnosis:\n\n  * Diagnosed with alcohol dependence according to the International Classification of Diseases, 10th Edition (ICD-10), and alcohol use disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n  * Diagnosed with schizophrenia spectrum disorder according to ICD-10 and DSM-5\n* AUDIT Score: Alcohol Use Disorder Identification Test (AUDIT) score greater than 15.\n* Body Mass Index (BMI): BMI of 23 kg\u002Fm² or higher.\n* Age Range: Between 18 and 70 years old (inclusive).\n* Heavy Alcohol Consumption: Defined as 4 or more heavy drinking days within a consecutive 21-day period during the 28 days preceding the baseline evaluation. The 21-day period will be selected based on the largest total alcohol consumption and the greatest number of heavy drinking days within the 28-day timeframe. This will be assessed using the Timeline Followback (TLFB) method. Heavy drinking days are defined as days with an alcohol intake of 4 or more units (48 g of alcohol) for women and 5 or more units (60 g of alcohol) for men.\n\nExclusion Criteria:\n\n* Intellectual Disability: individuals with a diagnosis of intellectual disability.\n* Acute Psychosis: Acute exacerbation of psychosis, as indicated by a score of 6 or 7 on the Clinical Global Impression-Severity (CGI-S) scale.\n* Coercive Measures: Current use of coercive measures, which includes individuals sentenced to treatment ('dom til behandling').\n* Suicidal Behaviour: Evidence of current severe suicidal behaviour, as assessed by the investigator during clinical evaluation.\n* History of Severe Alcohol Withdrawal: History of delirium tremens or alcohol withdrawal seizures.\n* Severe Withdrawal Symptoms: Clinical Institute Withdrawal Assessment of Alcohol Scale, revised (CIWA-Ar) score greater than 9 at baseline examination.\n* Severe Neurological Conditions: Presence of severe neurological diseases, including severe traumatic brain injury.\n* Diabetes: Type 1 or 2 diabetes\n* Pregnant or Potentially Pregnant Women: WOCBP who are pregnant, breastfeeding, intend to become pregnant within the next 6 months (including 16 weeks of treatment plus two months after discontinuation of semaglutide), or are not using a highly effective contraceptive method throughout the study period. Highly effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level greater than 3 U\u002FL at inclusion will also be excluded.\n* Liver Function: Impaired hepatic function, defined as liver transaminases greater than three times the upper limit of normal.\n* Renal Function: Impaired renal function, indicated by an estimated glomerular filtration rate (eGFR) below 50 mL\u002Fmin and\u002For plasma creatinine above 150 μmol\u002FL.\n* Pancreatic Function: History of acute or chronic pancreatitis or amylase levels more than twice the upper limit of normal.\n* Thyroid Conditions: Previous medullary thyroid carcinoma (MTC) or a family history of MTC and\u002For Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).\n* Cardiac Issues: Decompensated heart failure (NYHA class III or IV), unstable angina pectoris, or myocardial infarction within the past 12 months.\n* Uncontrolled Hypertension: Systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg.\n* Alcohol Use Disorder Medication: Use of medications for alcohol use disorder (e.g., disulfiram, naltrexone, acamprosate, nalmefene) within the 28 days prior to inclusion as recorded in the Timeline Followback (TLFB) schedule.\n* Investigational Drugs: Receipt of any investigational drug within the past three months.\n* Weight-Lowering Medications: Use of other weight-lowering pharmacotherapy in the past three months.\n* Allergic Reactions: Hypersensitivity to the active substance or any of the excipients.\n* Language Barriers: Inability to speak and\u002For understand Danish.\n* Other Conditions: Any other condition that, in the investigator\\'s opinion, may interfere with participation in the trial.\n\nFor the subgroup of participants undergoing brain scans:\n\n* MRI Contraindications: any contraindications for MRI (e.g., magnetic implants, pacemaker, claustrophobia).\n* Benzodiazepine Use: Intermittent use of benzodiazepines within 12 days prior to the scanning session is not allowed. However, regular use of a stable dose of benzodiazepines is permitted.","ALL","18 Years","70 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Glucagon-like peptide-1 receptor agonists (GLP-1RAs), approved for the treatment of type 2 diabetes and obesity, have shown promise as a novel treatment for alcohol use disorder (AUD). This study aims to investigate whether the Glucose-dependent Insulinotropic Polypeptide\u002FGLP-1RA tirzepatide will reduce alcohol consumption in patients with a dual diagnosis of AUD and schizophrenia, a population in dire need of improved treatment options. To further investigate the neurobiological underpinnings of a potential dampening effect on alcohol consumption, functional magnetic resonance imaging (fMRI) brain scans will be applied.\n\nThe key anticipated outcomes include:\n\n* decreased alcohol consumption and\n* reduced alcohol cue-induced brain activity in the GIP\u002FGLP-1-treated patient group compared with the placebo group. To the best of the investigators knowledge, this has never been examined before.",[27,28,29,30,31,32,33,34],"Alcohol Use Disorder","Alcohol Abuse\u002FDependence","Alcohol Dependence","Alcoholism","Schizophrenia Disorders","Schizophrenia and Disorders With Psychotic Features","Schizophrenia and Schizophrenia Spectrum Psychosis","Schizophrenia",[36,37,38,39,40,41,42,43,44,45,46],"GLP-1","Glucagon-like peptide 1","fMRI","GIP","Glucose-dependent Insulinotropic Polypeptide","Tirzepatide","Mounjaro(R)","schizophrenia","alcohol","alcohol use disorder","dual diagnosis","RECRUITING","2026-02-05",{"date":50,"type":51},"2026-02-10","ACTUAL",{"date":53,"type":51},"2025-05-05",{"date":55,"type":21},"2028-12-31",{"name":57,"class":58},"Anders Fink-Jensen, MD, DMSci","OTHER",2,{"id":61,"slug":4,"hasResults":10,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100610986","NCT07234708","Feeling Safe Study","Feeling Safe: Feasibility and Acceptability Study Evaluating a New Psychological Intervention for People With Psychosis and Positive Delusional Symptoms","Inclusion Criteria:\n\n* Men and women aged 18 years and older\n* Diagnosis of schizophrenia spectrum disorders and other psychotic disorders according to DSM-5\n* Score ≥ 4 on the delusions item of the Positive and Negative Syndrome Scale (PANSS)\n* Presence of ideas of persecution with a degree of conviction \\> 60% in the last 3 months\n\nExclusion Criteria:\n\n* Presence of intellectual disability\n* Meet DSM-5 criteria for other mental health disorders, except for substance-related and addictive disorders",{"count":67,"type":21},35,[69],"NA","The goal of this study is to assess the acceptability and satisfaction with the psychological intervention Sentirnos Seguros (Feeling Safe) in people with psychotic disorders and positive delusional symptoms.\n\nThe main questions it aims to answer are:\n\n* Study participants will report high levels of acceptability and satisfaction with the Sentirnos Seguros programme.\n* The Sentirnos Seguros intervention will be beneficial for participants at a clinical and functional level, with higher scores in the post-treatment phase compared to the pre-treatment phase.",[33],[73,34,74,75],"Feeling Safe","Acceptability","Feasibility","2025-11-18",{"date":78,"type":51},"2025-11-21",{"date":80,"type":51},"2025-07-01",{"date":82,"type":21},"2028-05-01",{"name":84,"class":58},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",1,{"id":87,"slug":4,"hasResults":10,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":16,"minAge":94,"maxAge":18,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":107,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":85},"100599548","NCT07085923","Norwegian Mental Illness Heart Health Study","Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness","NORMI-Heart","Inclusion Criteria:\n\n* Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)\n* Current use of antipsychotic medication (first- or second generation) or lithium\n* Body Mass Index \\> or = 27 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nPsychiatric condition:\n\n* Inability to provide informed consent\\*\n* Acute psychiatric crisis\\*\n* Significant cognitive impairment\\* \\*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment\n\nMedication initiated during the intervention period:\n\n* GLP-1 receptor agonists\n* Antihypertensive medication\n* Antidiabetic medication\n* Lipid-lowering medication\n\nAlcohol consumption:\n\n-More than 14 units per week (men) or more than 7 units per week (women)\n\nSomatic conditions:\n\n* Type 1 diabetes\n* Established cardiovascular disease\n* Body Mass Index (BMI) \\\u003C27 kg\u002Fm²\n* Pregnancy\n* Inability to perform physical exercise\n\nSomatic risk findings at baseline:\n\n* HbA1c \\>57 mmol\u002Fmol (7.4%)\n* LDL cholesterol \\>5.0 mmol\u002FL\n* Blood pressure \\>180\u002F100 mmHg\n* Active malignant disease",true,"25 Years",{"count":96,"type":21},70,[69],"Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.\n\nThe goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.\n\nThe main questions it aims to answer are:\n\n* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?\n* Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?\n* Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?\n\nResearchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.\n\nDuring the six month program, participants in the lifestyle group will:\n\n* Meet with a clinical dietitian once a month for dietary counselling\n* Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan\n\nAround 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.",[100,101,102,33,103,104,105,106],"Cardio Vascular Disease","Metabolic Syndrome (MetS)","Severe Mental Disorder","Bipolar Disease Type I","Overweight and\u002For Obesity","CVD Risk Factors","Severe Mental Illness",[106,108,109,110,111,112,34,113,114,115,116],"Cardiovascular Disease","Lifestyle Intervention","Healthy Diet","Exercise","CVD-risk","Antipsychotic Medication","Bipolar Disorder","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":119,"type":51},"2025-10-02",{"date":121,"type":51},"2025-09-16",{"date":123,"type":21},"2028-06-30",{"name":125,"class":58},"Madeleine Elisabeth Angelsen",{"id":127,"slug":4,"hasResults":10,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":10,"sex":16,"minAge":132,"maxAge":18,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":85},"100607706","NCT07192042","Investigation of Using Non-Wearable Devices to Assess Sleep- Disordered Breathing in Hospitalized Patients With Schizophrenia","IUNWD","Inclusion Criteria:\n\n* Age: Participants must be between 20 and 70 years old.\n* Diagnostic Criteria: Schizophrenia spectrum disorders, including schizophrenia, schizoaffective disorder, and schizophreniform disorder, diagnosed according to DSM-5 criteria and confirmed with the MINI 7.0 (Chinese version).\n* Clinical Stability and Informed Consent: At the time of admission, participants should be in a relatively stable condition, able to understand the study procedures, and capable of providing written informed consent. If patients are unable to fully comprehend due to illness severity or cognitive limitations, consent may be obtained from a legal guardian or family member, with subsequent confirmation of consent by the patient once their condition improves.\n\nExclusion Criteria:\n\n* Treatment-related: Patients who are currently receiving continuous positive airway pressure (CPAP) therapy for OSA.\n* Other Major Central Nervous System Disorders: Presence of other serious conditions that may significantly affect central nervous system function, aside from schizophrenia, such as major depressive disorder or bipolar disorder.\n* Severe Medical Illnesses: Including, but not limited to, malignant tumors, end-stage cardiopulmonary disease, neuromuscular disorders severely affecting motor or respiratory function, uncontrolled epileptic seizures, or other serious medical conditions that prevent patients from sleeping in the supine position.\n* Clinical Judgment: Patients deemed unsuitable for participation due to clinical conditions (e.g., agitation, non-cooperation, or other safety concerns).","20 Years",{"count":134,"type":21},80,"OBSERVATIONAL","This research project aims to evaluate the prevalence of comorbid OSA and its impact on disease progression among hospitalized schizophrenia patients using non-wearable devices.",[33],[34,139,140,141,142],"Sleep- Disordered Breathing","Obstructive Sleep Apnea","Non-Wearable Devices","Hospitalized Patients","2025-09-17",{"date":145,"type":51},"2025-09-25",{"date":147,"type":51},"2025-09-09",{"date":149,"type":21},"2026-04-30",{"name":151,"class":58},"Taipei Medical University Shuang Ho Hospital",""]