[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-and-disorders-with-psychotic-features\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-and-disorders-with-psychotic-features":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":5},"100588260","phase-2-effects-of-tirzepatide-on-alcohol-intake-in-patients-diagnosed-with-schizophrenia-and-alcohol-use-disorder-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":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33,34,35],"Alcohol Use Disorder","Alcohol Abuse\u002FDependence","Alcohol Dependence","Alcoholism","Schizophrenia Disorders","Schizophrenia and Disorders With Psychotic Features","Schizophrenia and Schizophrenia Spectrum Psychosis","Schizophrenia",[37,38,39,40,41,42,43,44,45,46,47],"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":51,"type":52},"2026-02-10","ACTUAL",{"date":54,"type":52},"2025-05-05",{"date":56,"type":22},"2028-12-31",{"name":58,"class":59},"Anders Fink-Jensen, MD, DMSci","OTHER",{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":71,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100583141","karolinska-schizophrenia-project-100583141","NCT06872463","Karolinska Schizophrenia Project","Brain Immunoactivation in Drug-Naive Patients with First Episode Schizophrenia","KaSP","Inclusion Criteria:\n\nFor FEP:\n\n* Diagnosis as assessed using DSM-IV of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder\n* First exposure to anti-psychotic medication less than 4 weeks prior to inclusion\n\nExclusion Criteria:\n\nFor FEP:\n\n\\- Other dominant psychiatric illness deemed to be related to current psychotic symptoms\n\nFor HC:\n\n* A history of diagnosis of a major psychiatric disorder, including substance use disorders.\n* Family history of psychotic disorders in first degree relatives.\n\nFor all:\n\n* Evidence based on medical history, clinical signs, MRI or laboratory tests of clinically significant somatic disorder, or previous disorder with brain engagement (e.g. tumour, neuroinflammatory disease, epilepsy) or significant brain trauma.\n* Exposure to an effective radiation dose of 25 mSv during the past year.\n* Pregnancy, lactating or breastfeeding (women).\n* Meets diagnostic criteria of substance use disorder (excluding nicotine dependence) as assessed using DSM-IV or as determined using repeated positive urine screens during the course of the study.\n* Metallic object in the eye, or ferro\u002Felectromagnetic implants. History of claustrophobic anxiety during MRI.\n* Symptoms of severe bacterial, fungal, or viral infection (including upper respiratory tract infection), with systemic effects as detected by e.g. fever, within 7 days prior to inclusion.\n* Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.\n* Blood donation (1 unit or more) within 90 days prior to Screening, plasma donation from 1 week prior to Screening, and platelet donation from 6 weeks prior to inclusion.\n* Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment. This may include very high symptom severity or signs of aggressiveness and hostility.",true,{"count":70,"type":22},200,"5 Years","OBSERVATIONAL","KaSP is a multimodal observational study with the goal of clarifying underlying mechanisms that cause psychotic disorders, such as schizophrenia. Participants with psychotic symptoms are recruited early after first contact with health care, within 4 weeks of starting anti-psychotic medication, and are compared to controls without psychiatric diagnoses on several measures.",[75],"Schizophrenia and Disorders with Psychotic Features",[77,78,35],"Psychosis","Psychotic disorders","2025-03-10",{"date":81,"type":52},"2025-03-12",{"date":83,"type":52},"2011-01-25",{"date":85,"type":22},"2032-12-31",{"name":87,"class":59},"Karolinska Institutet",1]