[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizoaffective-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizoaffective-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,49,81,109,144,169,190,218,251,272,297,329,354,375,400,433,453,480,503,527,548,569,594,623,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054230","phase-4-exercise-and-olanzapine-samidorphan-100054230",false,"NCT06740890","Exercise and Olanzapine-samidorphan","A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain","Inclusion Criteria:\n\n1. Age between 18-65, inclusive at Visit 1.\n2. DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I\u002FII\u002FNOS disorder at Visit 1.\n3. Body Mass Index (BMI) of 18.0-40.0 kg\u002Fm2, inclusive, at Visits 1 and 2.\n4. Willing to provide informed consent at Visit 1.\n5. Medically and psychiatrically stable for study participation at Visit 1.\n6. Responsive to an antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1.\n7. Can benefit from participation in this study and has a reason to participate, such as inadequate efficacy on current treatment, side effects on current treatment, desire to start olanzapine-samidorphan or try structured exercise program (assessed at Visit 1).\n8. Maintained a stable body weight (change \\\u003C 5%) for at least 3 months prior to Visit 1.\n9. Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only) (assessed at Visit 1 and Visit 2).\n\nExclusion Criteria:\n\n1. Positive drug screen for opioids, phencyclidine, amphetamine\u002F methamphetamine, or cocaine at Visit 1 or Visit 2.\n2. Diagnosis of moderate or severe substance use disorder, anorexia nervosa, bulimia, binge eating disorder or any other clinically significant eating disorder at Visit 1.\n3. EKG abnormality that is clinically significant including a QT interval \\> 450 msec for men and \\> 470 msec for women, as corrected by the Fridericia formula (QTcF) at Visit 1.\n4. Use of olanzapine+samidorphan for any reason in the last six months prior to Visit 1, any history of poor or inadequate response to treatment with olanzapine or no justifiable reason to expect improvement on olanzapine as assessed at Visit 1.\n5. Taken opioid agonists (e.g., codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and\u002For anticipates a need to take opioid medication during the study period (e.g., planned surgery), or has taken opioid antagonists including naltrexone (any formulations) or naloxone within 60 days prior to Visit 1.\n6. Pregnant or breast feeding women. Women of child-bearing potential must have a negative serum beta-hCG pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2.\n7. Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise subject safety on study medication or exercise, or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following (as assessed at Visit 1):\n\n   1. Clinically significant hypotension or hypertension not stabilized on medical therapy.\n   2. Unstable thyroid dysfunction in the past 6 months (e.g., hypothyroidism, hyperthyroidism, or thyroiditis that was untreated, or discovered and treatment was initiated within the 6 months prior to screening).\n   3. Personal or family history of neuroleptic malignant syndrome, has a history of clinically significant extrapyramidal symptoms when taking olanzapine, or has had clinically significant tardive dyskinesia.\n   4. Neurological conditions include the following:\n\n      * History of seizure disorder or a condition associated with seizures (except history of febrile seizures).\n      * History of brain tumor, subdural hematoma, stroke or any other clinically significant neurological condition within the 12 months prior to Visit 1.\n      * Head trauma with loss of consciousness within the 12 months prior to Visit 1.\n      * Active, acute or chronic CNS infection.\n   5. Cardiac condition that might confound study results, pose additional risk when administering the study drug or exercise regimen to the subject, or preclude successful completion of the study. Conditions include the following:\n\n      * Clinically significant cardiac arrhythmia, cardiomyopathy, a cardiac conduction defect, or a history of myocardial infarction or unstable angina within 6 months prior to Visit 1.\n8. Currently taking any contraindicated medications as per the approved labeling for Olz-Sam (see section 6.5 for details) at Visit 1 and Visit 2.\n9. Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to Visit 1 or current at Visit 2\n10. Inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss at Visit 1.\n11. Joined a weight management program or had significant changes in diet or exercise regimen within 6 weeks prior to Visit 1 or plans to join a weight management program during the study as assessed at Visit 1.\n12. History of diabetes (assessed at Visit 1).\n13. Laboratory abnormality that would compromise the well-being of the subject, or any of the following specific laboratory results at Visit 1:\n\n    1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\> 2 times the upper limit of the laboratory normal reference range\n    2. Absolute neutrophil count (ANC) \\\u003C1.5 x 10\\^3 μL\n    3. Platelet count \\\u003C 75 x 10\\^3 uL\n    4. Serum creatinine \\> 1.5 mg\u002FdL\n    5. Dyslipidemia, defined for this study as total fasting cholesterol \\> 280 mg\u002FdL or fasting triglycerides \\> 500 mg\u002FdL\n    6. Hemoglobin A1c (HbA1c) \\> 6.0%\n    7. Fasting plasma glucose \\> 126 mg\u002FdL (7.0 mmol\u002FL)\n14. Is not fit for the trial in the opinion of the investigator at Visit 1 and Visit 2.","ALL","18 Years","65 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I\u002FII\u002FNOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz\u002FSam) plus four weeks of aerobic exercise.",[28,29,30,31],"Schizophenia Disorder","Schizoaffective Disorder","Bipolar Disorder I or II","Bipolar Disorder NOS",[33,34,35],"Exercise","Antipsychotic induced weight gain","olanzapine-samidorphan","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2025-06-26",{"date":44,"type":22},"2027-04",{"name":46,"class":47},"New York State Psychiatric Institute","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100641562","optimizing-cbsst-with-executive-function-training-for-schizophrenia-r33-100641562","NCT07658391","Optimizing CBSST With Executive Function Training for Schizophrenia (R33)","Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia","ECBSST R33","Inclusion Criteria:\n\n1. Voluntary informed consent to participate;\n2. Age 60 years or older;\n3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;\n4. Be clinically stable as operationalized by (1) not having been admitted to a psychiatric hospital within the three months prior to assessment, (2) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (3) and ascertained to be clinically and medically stable by one the study investigators;\n5. Be willing and able to speak English;\n6. Be able to read and converse (with corrected vision or hearing if needed).\n\nExclusion Criteria:\n\n1. Meets criteria for a cognitive disorder or for a neurological or other medical disorder affecting the ability to participate in Executive Function Training or CBSST;\n2. Meets diagnostic criteria for bipolar disorder, current major depressive episode, or substance abuse or dependence within the six months prior to the baseline assessment except for caffeine or nicotine;\n3. Received electroconvulsive therapy within six months of the baseline assessment.","60 Years",{"count":59,"type":22},106,[61],"NA","This randomized controlled clinical trial will test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). E-CBSST will be delivered to adults with late-life schizophrenia to determine if it increases Cognitive Behavioral Social Skills Training skills learning more than a supportive contact control condition and leads to improved functioning.",[64,29],"Schizophrenia",[64,66,67,68,69],"serious mental illness","randomized clinical trial","executive function training","Cognitive Behavioral Social Skills Training","NOT_YET_RECRUITING","2026-06-18",{"date":73,"type":40},"2026-06-23",{"date":75,"type":22},"2026-10-01",{"date":77,"type":22},"2029-06",{"name":79,"class":47},"University of California, San Diego",2,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100601024","phase-4-a-study-to-evaluate-the-effectiveness-of-valbenazine-in-adult-participants-with-tardive-dyskinesia-td-who-remain-symptomatic-while-receiving-or-after-stopping-a-vesicular-monoamine-transporter-2-vmat2-inhibitor-100601024","NCT07105111","A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","Key Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder\n* Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening\n\nKey Exclusion Criteria:\n\n* Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD\n* Diagnosis of moderate or severe substance use disorder in the last 6 months\n* History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment",{"count":89,"type":22},50,[25],"This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.",[64,29,93,94,95],"Bipolar Disorder","Major Depressive Disorder","Tardive Dyskinesia",[97],"Valbenazine","2026-06-15",{"date":100,"type":40},"2026-06-16",{"date":102,"type":40},"2025-08-29",{"date":104,"type":22},"2027-01",{"name":106,"class":107},"Neurocrine Biosciences","INDUSTRY",22,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":131,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100613164","phase-3-cognitive-strategies-in-early-psychosis-2-100613164","NCT07263022","Cognitive Strategies in Early Psychosis 2","COSTEP 2","Inclusion Criteria:\n\n* Between the ages of 18 and 35\n* Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment\n* Estimated IQ of 70 or above\n* Proficient at English as determined through interactions with the study team\n* No change in psychiatric medication within a week of enrollment or MRI study visits\n* No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI\u002FCo-Is\n\n  * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days.\n  * Participants are to have no changes to medications in the past 7 days before drug administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).\n\nExclusion Criteria:\n\nMedical Criteria:\n\n* Presence of the following medical concerns as determined by the study PI:\n\n  * Major neurological disorder\n  * History of a clinically significant head injury with or without prolonged unconsciousness\n  * Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating\n* History of any of the following as reported by the participant:\n\n  * Renal impairment, injury, or disease\n  * Hepatic impairment, injury, or disease\n  * Myocardial infarction or heart disease, or endorsement of history of or of cardiac symptoms at intake:\n\n    * Dyspnea\n    * Palpitations\n    * Orthopnea\n    * Pedal oedema\n    * Significant dizziness\n    * Syncope\n    * Claudication\n  * Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis\n* Presence of unmanaged hypertension (\\>140\u002F90) or elevated resting heart rate (\\>100 bpm)\n* Abnormal clinical laboratory values:\n\n  * uACR \\> 30 mg\u002Fg\n  * creatinine level \\>0.95 mg\u002FdL\n  * AST or ALT \\> 50 U\u002FL\n  * Bilirubin \\> 1.2 mg\u002FdL\n  * Total Protein \\\u003C 6 g\u002FdL\n* Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)\n* Allergies to study drugs\n* Is pregnant, planning to become pregnant, or is breastfeeding\n* Cannot pass the visual acuity test\n* Cannot pass the CMRR Subject Safety Screen due to MRI contraindications\n\nMental health criteria:\n\n* Meets criteria for a severe substance or alcohol use disorder within 3 months of enrollment\n* Lifetime history of a stimulant use disorder\n* Current manic episode as determined by the MINI\n* History of psychiatric hospitalization within 3 months of enrollment\n* Meets criteria for clinical risk of suicidal behavior, as defined by:\n\n  * Clinician judgment\n  * A suicide attempt within 3 months of enrollment\n  * Active suicidal ideation at screening or baseline, as indicated by the C-SSRS Screener\n  * Previous intent to act on suicidal ideation with a specific plan and\u002For preparatory acts within 3 months of enrollment, as indicated by the C-SSRS Screener\n* Symptom severity scores in the severe (6) or extremely severe (7) range on the BPRS for the following items: suicidality, disorientation, bizarre behavior, excitement, elevated mood\n* Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating\n\nOther criteria:\n\n* Unable or unwilling to provide informed consent\n* Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study\n* Current guardianship\n* Is under civil commitment or under a stay of civil commitment\n* Illiteracy\n* Has engaged in significant cognitive training, in the opinion of the PI, in the last year","35 Years",{"count":118,"type":22},24,[120],"PHASE3","The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are:\n\n* Does a single dose of modafinil change how people with psychosis play the brain games?\n* Does a single dose of d-serine change how people with psychosis play the brain games?\n* Does a single dose of modafinil change brain activity?\n* Does a single dose of d-serine change brain activity?\n\nParticipants will:\n\n* Complete an interview and self-report questionnaires.\n* Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.\n* Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart.\n* Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.\n* Play brain games on a computer that measure decision making, thinking, and problem solving skills",[123,124,29,125,126,127,128,129,130],"Psychosis","Schizophrenia Disorder","Major Depressive Disorder With Psychotic Features","Bipolar Disorder With Psychotic Features","Psychosis NOS","Schizophreniform Disorder","Psychotic Disorder","Cognition",[130,132,133,134],"Decision Making","fMRI","Psychosis spectrum disorders","2026-05-28",{"date":137,"type":40},"2026-05-29",{"date":139,"type":22},"2026-07-07",{"date":141,"type":22},"2030-04-30",{"name":143,"class":47},"University of Minnesota",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100407031","phase-4-clozapine-response-in-biotype-1-100407031","NCT04580134","CLOZAPINE Response in Biotype-1","Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)","Inclusion Criteria:\n\n* 18-60y\u002Fo; males and females; all races and ethnicities; able to provide written informed consent; able to read, speak, and understand English; medically stable; meeting DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features (we will use DSM-IV to be consistent with prior B-SNIP samples); PANSS total score of ≥70 and at least one item scored ≥5 or two items scored ≥4 on PANSS Positive Subscale; normal baseline values for absolute neutrophil count (ANC above 1500\u002Fmm3)\n\nExclusion Criteria:\n\n* premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest, age-corrected standardized score); comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months; neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovascular disorder, AIDS) that may affect central nervous system function; concomitant medications known to affect EEG properties (i.e., lithium, anticonvulsants, benzodiazepines) or strong CYP 1A2 inhibitors (e.g., ciprofloxacin, enoxacin) or strong CYP 3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital, rifampin) which cannot be safely discontinued; vulnerable populations (e.g., pregnant, nursing, incarcerated); unwilling to use reliable means of contraception; history of neuroleptic malignant syndrome; prior treatment with clozapine, prior treatment with long-acting injectable antipsychotics that are 1-month formulations within the past 3 months and for 3-month formulations within the past 6 months; intolerable side effects to either clozapine or risperidone in lifetime, or a previously failed trial of either clozapine or risperidone at adequate doses in lifetime; history of drug reaction with eosinophilia and systemic symptoms syndrome (DRESS), also known as drug-induced hypersensitivity syndrome (DIHS); high risk for suicide defined as more than 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded; current homicidal ideation with plan and intent such that outpatient care is precluded.",{"count":152,"type":22},524,[25],"The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \\~50% each) in order to enroll n=320 (B1 and B2) into the RCT.",[64,29,156],"Bipolar 1 Disorder",[158],"Schizophrenia, Bipolar, Psychosis, Biomarker, Biotype, BSNIP, B-SNIP, IEA","2026-05-07",{"date":161,"type":40},"2026-05-11",{"date":163,"type":40},"2022-03-01",{"date":165,"type":22},"2027-04-30",{"name":167,"class":47},"University of Texas Southwestern Medical Center",5,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100455257","phase-4-clozapine-for-the-prevention-of-violence-in-schizophrenia-a-randomized-clinical-trial-100455257","NCT05208190","Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial","REVISIT-C","Inclusion Criteria:\n\n* Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5)\n* commission of a minor or serious act of violence as measured by the MCVI in the last six months\n* willing and able to provide informed consent\n* medically stable in judgment of physician providing study treatment\n* appropriate for treatment with either clozapine or TAU, i.e., that there is clinical equipoise between the two treatment options. Individuals who are currently medication free or on any antipsychotic, with the exception of clozapine or long-acting injectable medication with a dosing interval of more than 30 days will be eligible\n\nExclusion Criteria:\n\n* An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow\n* A history of intolerance\u002Fallergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)\n* A history of intellectual impairment\n* pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control\n* Individuals who score a 3, 4, or 5 within the previous month on the suicidal ideation section of the Columbia Suicide Severity Rating Scale (CSSRS), have any suicidal behavior (not including Not Suicidal Self Injury) within the previous 3 months, or are, in the opinion of the investigator, at too high of a risk for suicide to be safety treated in a randomized trial in which they may not be treated with clozapine\n* Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial",{"count":177,"type":22},280,[25],"Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings",[64,29],"2026-04-28",{"date":183,"type":40},"2026-05-04",{"date":185,"type":40},"2022-03-17",{"date":187,"type":22},"2028-12-31",{"name":46,"class":47},7,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":198,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":199,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":48},"100164096","database-registry-for-neural-network-biomarkers-in-psychosis-100164096","NCT01409109","Database Registry for Neural Network Biomarkers in Psychosis","Database Registry to Examine Brain Connections and Brain Function in Mental Disorders and Neural Network Biomarkers for Relational Memory and Psychosis in Schizophrenia","Imaging","Inclusion Criteria:\n\nVolunteers with Schizophrenia or other mental illness\n\n* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of Schizophrenia or Schizoaffective disorder\n* Competent to give informed consent\n* All races and ethnicities\n* Eyesight corrected to 20-40 or better\n* Able to read, speak, and understand English\n\nHealthy volunteers\n\n* No past or current severe mental illness\n* All races and ethnicities\n* Eyesight corrected to 20-40 or better\n* Able to read, speak, and understand English\n\nExclusion Criteria:\n\nVolunteers with schizophrenia or other mental illness\n\n* Diagnosis of an organic brain disease\n* Diagnosis of DSM-IV-TR alcohol or substance abuse within the last month or DSM-IV-TR alcohol or substance dependence within the last three months\n* Serious, unstable medical illness\n* History of serious head injury\n* Pregnant women\n\nHealthy volunteers\n\n* History of psychiatric illness\n* Current use of psychoactive drugs excluding nicotine and caffeine\n* Diagnosis of an organic brain disease\n* Serious, unstable medical illness\n* History of serious head injury\n* Pregnant women",true,{"count":200,"type":22},1000,"OBSERVATIONAL","Several observations have been made with magnetic resonance imaging (MRI) that characterize brain connections and brain function in individuals with schizophrenia and other mental disorders. For example, research investigating schizophrenia focuses on the dysfunction of connections within and between the medial temporal lobe and the prefrontal cortex as well as other pertinent brain regions. This database registry will allow for the collection of clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and functional magnetic resonance imaging (fMRI) data on individuals with and without mental disorders to better understand how connections in the brain and various brain regions function differently while volunteers perform various cognitive tasks. This is an observational study that is being conducted to collect data and place it in a registry for current and future investigational questions related to imaging in mental disorders.",[64,29],[64,205,206,207,208,209],"Schizoaffective","Neuroimaging","Magnetic Resonance Imaging (MRI)","Functional Magnetic Resonance Imaging (fMRI)","Spectroscopy","2026-04-20",{"date":212,"type":40},"2026-04-23",{"date":214,"type":4},"2010-03",{"date":216,"type":22},"2029-04",{"name":167,"class":47},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":250},"100585170","enhancing-veteran-clinical-collaboration-in-va-prrcs-100585170","NCT06898879","Enhancing Veteran-Clinical Collaboration in VA PRRCs","Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers","EVCC VPRRC","Inclusion Criteria:\n\n1. be a Veteran currently receiving PRRC, MHICM and\u002For BHIP services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)\n2. meet SAMHSA criteria of serious mental illness; i.e., \"having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities,\" based on chart review and clinician consultation if needed\n3. Be age 18 or above\n4. Be fluent and literate in English.\n5. Agree to have a subset of VA mental health treatment appointments audiotaped\n\nExclusion Criteria:\n\n1. primary substance use or organic neurological disorder diagnosis determined by chart review\n2. are determined by clinician and\u002For study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation\n3. have a history and\u002For current risk of violence that clinicians and\u002For study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff).",{"count":227,"type":22},119,[61],"Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and\u002For have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.",[64,29,231,93,94],"Delusional Disorder",[66,233,234,235,236,237,238,239],"psychosis","collaborative decision-making","shared decision-making","veterans","recovery","personal recovery","empowerment","2026-04-14",{"date":242,"type":40},"2026-04-15",{"date":244,"type":22},"2026-07-01",{"date":246,"type":22},"2029-09-30",{"name":248,"class":249},"VA Office of Research and Development","FED",3,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":48},"100516324","accelerated-transcranial-magnetic-stimulation-for-people-with-schizophrenia-treated-with-clozapine-100516324","NCT06003036","Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine","Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment","Inclusion Criteria:\n\n1. A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder\n2. age 18-50 years\n3. at least 4 months of clozapine treatment\n4. history of at least 2 failed antipsychotic trials\n5. competency and willingness to sign informed consent\n6. A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg\u002Fday\n\nExclusion Criteria:\n\n1. Serious neurologic or medical condition\u002Ftreatment that impacts the brain\n2. a significant risk of suicidal or homicidal behavior\n3. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent\n4. pregnancy or postpartum (\\\u003C6 weeks after delivery or miscarriage)\n5. history of treatment with electroconvulsive therapy\n6. contraindications for magnetic resonance imaging (e.g., a pacemaker)\n7. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-verified moderate or severe substance use disorder, including alcohol use disorder\n8. seizure disorder or prior history of seizures on clozapine\n9. patients taking both bupropion and clozapine\n10. prior issues with intermittent theta burst stimulation\u002Ftranscranial magnetic stimulation administration\n\nConcomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case basis.","50 Years",{"count":21,"type":22},[61],"In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.",[64,29],"2026-04-06",{"date":265,"type":40},"2026-04-13",{"date":267,"type":40},"2023-12-01",{"date":269,"type":22},"2026-07",{"name":271,"class":47},"Deepak K. Sarpal, M.D.",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":48},"100379924","phase-2-synbiotic-compound-to-reduce-symptoms-of-schizophrenia-100379924","NCT04226898","Synbiotic Compound to Reduce Symptoms of Schizophrenia","A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation","Inclusion Criteria:\n\n* Age 18-65, inclusive.\n* Capacity for written informed consent.\n* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5).\n* Outpatient at the time of enrollment.\n* Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit.\n* Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.\n* Proficient in the English language.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM.\n* Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment.\n* A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder.\n* History of IV drug use.\n* DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility.\n* Participated in any investigational drug trial in the past 30 days.\n* Pregnant or planning to become pregnant during the study period.\n* Receipt of antibiotic medication within the 14 days prior to visit 2 (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics). Of note, patients on antibiotic may be re-screened once the minimum duration of time since antibiotics use has been met.\n* Current and regular use of a probiotic and or prebiotic supplement within the past 2 weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.\n* Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease",{"count":280,"type":22},68,[282],"PHASE2","The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.",[64,29],[64,29,286,287],"Synbiotics","Synbiotic","2026-04-01",{"date":290,"type":40},"2026-04-07",{"date":292,"type":40},"2022-02-21",{"date":294,"type":22},"2027-12",{"name":296,"class":47},"Sheppard Pratt Health System",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":312,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100471268","shared-decision-making-for-antipsychotic-medications-100471268","NCT05416658","Shared Decision Making for Antipsychotic Medications","Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis","Inclusion Criteria:\n\n* Ages 18 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified\u002Funspecified schizophrenia spectrum and other psychotic disorders (ICD-10-CM Diagnosis Code F20.x)\n* Current\u002Fpast experiences with antipsychotic medications (APM; e.g., currently taking any antipsychotic medication, stopped taking, or considering stopping).\n* Receive FEP treatment in one of OnTrackNY clinics\u002Fsites randomized to intervention or treatment as usual (TAU) - Willing to participate in research interviews after each APM visit during the study period (3 months)\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* No experience with APM\n* Not fluent (speaking, reading, writing) in English","30 Years",{"count":306,"type":22},120,[61],"This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.",[64,29,310,231,311],"Schizophreniform Disorders","Other Specified Schizophrenia Spectrum and Other Psychotic Disorder",[313,233,314,315,316,317,318,319,320],"Shared decision making","schizophrenia","antipsychotic","medication","intervention","decision aid","coordinated specialty care (CSC)","randomized controlled trial (RCT)","2026-03-24",{"date":323,"type":40},"2026-03-30",{"date":325,"type":22},"2027-01-01",{"date":327,"type":22},"2027-06-30",{"name":46,"class":47},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":48},"100630475","improving-health-literacy-in-patients-with-schizophrenia-spectrum-disorder-100630475","NCT07488156","Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder","The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder","Inclusion Criteria:\n\n* Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient behavioral health unit ages 18 and older with a new or previous diagnosis of schizophrenia spectrum disorder outside of substance use disorders\n* Patients must be proficient in English.\n* Patients must have a government issued social security number (required for reimbursement through the university).\n\nExclusion Criteria:\n\n* Patients at UMCNO that are ages 17 or younger\n* Patients with SSD and concomitant intellectual disability, as evidenced by prior documented history on chart review or patients suspected to have intellectual disability or impairment based on clinical interactions\n* Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications\n* Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization\n* Patients that are not proficient in English\n* Patients that do not have a government issued social security number",{"count":337,"type":22},34,[61],"The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder\n\nThis interventional study is aimed at:\n\n* assessing and improving the health literacy and\n* assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.",[124,29,123],[342,64,343,344],"Educational interventions","Schizophrenia spectrum disorders","Health literacy","2026-03-17",{"date":347,"type":40},"2026-03-23",{"date":349,"type":22},"2026-03-01",{"date":351,"type":22},"2028-01-01",{"name":353,"class":47},"Louisiana State University Health Sciences Center in New Orleans",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":80},"100524364","cerebellar-modulation-of-cognition-in-psychosis-100524364","NCT06107764","Cerebellar Modulation of Cognition in Psychosis","Inclusion Criteria:\n\n* Age between 18-55 years\n* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month\n* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:\n\n  * Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;\n  * History of fainting spells of unknown or undetermined etiology that might constitute seizures\n  * History of multiple seizures or diagnosis of epilepsy\n  * Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n  * Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n  * Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or transcutaneous electric nerve stimulation unit\n  * Ventriculo-peritoneal shunt\n  * Signs of increased intracranial pressure\n  * Intracranial lesion\n  * History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n  * Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.","55 Years",{"count":362,"type":22},95,[61],"The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).\n\nParticipants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.",[64,29,366,123],"Bipolar Disorder I","2026-03-16",{"date":345,"type":40},{"date":370,"type":40},"2024-07-31",{"date":372,"type":22},"2029-12",{"name":374,"class":47},"Mclean Hospital",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":198,"sex":17,"minAge":18,"maxAge":258,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":48},"100573376","decision-making-in-schizophrenia-a-combined-neuroimaging-and-experience-sampling-study-100573376","NCT06745479","Decision-Making in Schizophrenia: A Combined Neuroimaging and Experience Sampling Study","Promoting Adaptive Decision-Making in Schizophrenia Through Improved Evidence Integration: A Combined Neuroimaging and Experience Sampling Study","Inclusion Criteria\n\nThe following criteria apply to all subjects:\n\n1. Between ages of 18-50.\n2. Have capacity to provide informed consent\n3. Fluent communication in English\n4. Willingness and ability to follow study requirements, as evidenced by an ability to provide written or virtual informed consent and read, and complete, study procedures.\n5. Cognitive ability to understand tasks and estimated IQ greater than 70.\n\nThe following criteria apply to subjects with schizophrenia:\n\n1\\. Primary diagnosis of schizophrenia or schizoaffective disorder\n\nThe following additional criteria apply to subjects without schizophrenia:\n\n1\\. Inclusion based on subject matched to psychiatric group based on age, sex, race\u002Fethnicity, and education level.\n\nExclusion Criteria\n\nThe following criteria apply to all subjects:\n\n1. Self-disclosed or noticeable intoxication from alcohol or illicit drugs (e.g., arriving to participate in the study drunk\u002Fhigh)\n2. Self-disclosure of consistent current substance use other than nicotine, alcohol, or cannabis (e.g. cocaine, heroin).\n3. Many-year history of severely disordered substance use other than nicotine\u002Ftobacco (determined via interview)\n4. Significant physical health disorder, robust physical health conditions, neurological disease\u002Fdisorder (e.g., Parkinson's, history of strokes).\n5. History of traumatic brain injury, head injury resulting in loss of consciousness for an extended duration or with noted neurobehavioral consequences.\n6. Electroconvulsive therapy within one month of participation.\n7. History of seizures or epilepsy.\n8. Currently untreated or unstable psychiatric and medical conditions.\n9. Intellectual disability\n10. Contra indications for MR imaging (detailed below)\n\nThe following additional criteria apply to subjects without schizophrenia:\n\n1. Pervasive history of problematic substance use (other than nicotine, alcohol, and mild-moderate cannabis use) as defined by meeting DSM-5 criteria for a substance use disorder.\n2. Diagnosis of, or first-degree relative with, significant psychiatric disorder (e.g., bipolar disorder, psychotic disorder, or Cluster A personality disorder).",{"count":383,"type":22},74,[61],"The goal of this clinical trial is to learn if attention and ways of thinking impact decision-making and brain processes related to decision-making in people with schizophrenia or schizoaffective disorder relative to people without either condition. It will also learn how brain functioning during decision-making relates to real-world decisions made during daily life. The main questions it aims to answer are:\n\n* Does paying attention to specific information impact decision-making and brain processes?\n* Does thinking in a certain way according to specific 'thinking strategies' improve brain processes related to decision-making?\n* Does brain functioning during decision-making relate to real-world choices to engage in activities?\n\nResearchers will compare brain functioning and decision-making on computer tasks of gambling after participants have been trained to use a positive thinking strategy. They will compare what is different in the brain and behavior when participants use this strategy and when they do not. Participants will also answer brief surveys about activities and feelings for a week in their daily lives.\n\nParticipants will:\n\n* Complete several hours of clinical interviewing, cognitive tests, and surveys of about symptoms, experiences, and personality\n* Complete computer tasks about gambling decisions during MRI brain scanning and while having their visual attention measured using eye-tracking\n* Complete brief surveys about their activities and feelings 5 times a day for 1 week using a cell phone. Each survey only take several minutes.",[64,29,387],"Control Subjects",[389,390,123,64,391],"Cognitive Strategy","Emotion Regulation","functional MRI","2026-03-09",{"date":394,"type":40},"2026-03-11",{"date":396,"type":40},"2025-01-07",{"date":327,"type":22},{"name":399,"class":47},"Rutgers, The State University of New Jersey",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":410,"conditions":411,"keywords":415,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":432},"100572985","biomarkersbiotypes-course-of-early-psychosis-and-specialty-services-100572985","NCT06740383","Biomarkers\u002FBiotypes, Course of Early Psychosis and Specialty Services","BICEPS","Inclusion Criteria:\n\n* Males and females, all races and ethnicities\n* 18-40 y\u002Fo\n* Meet DSM-5 criteria for a psychotic disorder, i.e. schizophrenia, schizophreniform, schizoaffective disorder, or bipolar I disorder or major depression with psychotic features, delusional disorder or psychosis N.O.S.\n* Able to read, speak, and understand English\n* Able and willing to provide written informed consent, and willing to commit to the study protocol\n* Illness duration from psychosis onset less than or equal to 4 years\n* At baseline only: receiving both psychopharmacology and psychotherapy\n\nExclusion Criteria:\n\n* Estimated premorbid intellectual ability \\\u003C70 (WRAT-4, Word Reading subtest, age-corrected standardized score)\n* Neurological or medical disorder that may affect brain function (seizure disorder, traumatic brain injury with a loss of consciousness greater than or equal to 30 min, history of stroke, AIDS, etc.)\n* Psychoses secondary to substance use i.e., Comorbid DSM-5 diagnosis of alcohol or substance use disorders that may explain the diagnosis of psychotic disorders (individuals with cannabis use disorders unrelated to psychosis onset will be allowed. Participants encouraged to abstain from substances for 24 hours prior to lab visits)\n\nMRI-Specific Exclusion Criteria:\n\n* Pregnant women\n* Presence of ferromagnetic objects in body\n* Weight or body size exceeding scanner capacity (\\>300 lbs)\n* Claustrophobia","40 Years",{"count":409,"type":22},320,"The Biomarkers\u002FBiotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.",[412,64,231,156,29,413,414],"Schizophrenia Spectrum and Other Psychotic Disorders","Psychosis Not Otherwise Specified","Early Psychosis",[314,416,417,418,419,233,420,421,422,423],"bipolar disorder","schizoaffective disorder","schizophreniform","major depression","delusional disorder","Biotypes","Biomarkers","coordinated specialty care","2026-03-06",{"date":426,"type":40},"2026-03-10",{"date":428,"type":40},"2023-01-01",{"date":327,"type":22},{"name":431,"class":47},"Beth Israel Deaconess Medical Center",6,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":48},"100479763","prebiotic-treatment-in-people-with-schizophrenia-100479763","NCT05527210","Prebiotic Treatment in People With Schizophrenia","FOCIS","Inclusion Criteria:\n\n1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder;\n2. Age 18-60 years;\n3. Considered clinically stable by the treating psychiatrist;\n4. Currently treated with an antipsychotic, with no dose changes in last 14 days;\n5. Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;\n6. BMI ≤ 40\n\nExclusion Criteria:\n\n1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol\n2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes\n3. Intellectual disability\n4. Acute antibiotic use\n5. Immune therapy within the last three months\n6. Prebiotic or probiotic treatment within the last three months\n7. Inability to understand English\n8. Inability to cooperate with study procedures\n9. Pregnant or lactation secondary to pregnancy\n10. Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.",{"count":441,"type":22},60,[61],"The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.",[64,29],"2026-03-05",{"date":392,"type":40},{"date":448,"type":40},"2023-01-25",{"date":450,"type":22},"2026-12-31",{"name":452,"class":47},"University of Maryland, Baltimore",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":468,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":48},"100623328","acceptability-feasibility-and-preliminary-outcomes-of-the-kiso-mind-app-for-outpatients-with-schizophrenia-spectrum-disorders-100623328","NCT07395206","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial","KISO","Inclusion Criteria:\n\n* ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder\n* Age: 18 - 65 years\n* Sufficient German Language Proficiency\n* Ability to Use a Smartphone\n\nExclusion Criteria:\n\n* Intensive Psychotherapy Protocols (more than one psychotherapy session a month)\n* CGI-Score \\\u003C 3; \\> 6\n* No smartphone\n* Neurological Disorders or Brain Damage\n* Acute Suicidality\n* Acute Heavy Substance Abuse or Addiction\n* Current Electroconvulsive Therapy",{"count":441,"type":22},[61],"The Kiso pilot study is a randomized controlled trial to test the acceptability and feasibility of a novel digital intervention, namely the Kiso Mind smartphone app. A parallel-group design is utilized. Participants either receive access to the Kiso Mind intervention and treatment-as-usual (TAU) in the experimental condition or receive treatment as usual (TAU) in the control condition. The intervention is designed for participants diagnosed with either schizophrenia (F20.0) or schizoaffective disorder (F25.0) according to the ICD-10.\n\nTo examine acceptability, feasibility, and preliminary effectiveness, both self-report and rater-based assessments are administered at baseline (T0) and at the end of the 12-week intervention period (post-intervention T1). Lastly, a qualitative interview will be conducted with participants from the experimental condition. The primary outcome of the present study is the acceptability and feasibility of the Kiso Mind app. The secondary outcome consists of general psychopathology, and positive-, negative-, depressive symptoms, as well as social functioning and self-efficacy ratings.",[123,465,466,467,64,29],"Psychotic Disorders","Primary Psychotic Disorders","Schizophrenia Spectrum Disorders",[123,465,466,64,29,467,469,470],"Digital Intervention","E-Health","2026-02-28",{"date":473,"type":40},"2026-03-03",{"date":475,"type":40},"2026-01-30",{"date":477,"type":22},"2026-06-30",{"name":479,"class":47},"Charite University, Berlin, Germany",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":198,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":487,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":500,"locationsCount":48},"100627386","lrfn5-and-olfm4-in-schizoaffective-disorder-100627386","NCT07447960","LRFN5 and OLFM4 in Schizoaffective Disorder","LRFN5 and OLFM4 Levels in Schizoaffective Disorder: A Cross-Sectional Case-Control Study","1. For Schizoaffective Disorder (SAD) Group:\n\n   \\*Inclusion Criteria:\n   * Diagnosis of SAD according to DSM-5-TR\n   * Acute manic episode\n   * Medication-free for at least one month prior to admission\n   * Age ≥ 18 years and \\\u003C65 years\n   * Provided informed consent\n\n   For Schizoaffective Disorder (SAD) Group:\n\n   \\*Exclusion Criteria:\n\n   • Hypertension\n\n   • Diabetes mellitus\n\n   • Chronic kidney disease\n\n   • Rheumatoid arthritis\n\n   • Systemic lupus erythematosus\n\n   • Cardiac illness\n\n   • Severe neurological disorders\n\n   • Immunological or systemic illness\n\n   • Primary psychiatric disorders other than SAD\n   * Alcohol\u002Fdrug\u002Fsubstance use\n2. For Healthy Control Group:\n\n   \\*Inclusion Criteria:\n\n   • No psychiatric diagnosis\n\n   • No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years and \\\u003C 65 years\n   * Provided informed consent\n\nFor Healthy Control Group:\n\n\\*Exclusion Criteria:\n\n* Hypertension\n* Diabetes mellitus\n* Chronic kidney disease\n* Rheumatoid arthritis\n* Systemic lupus erythematosus\n* Cardiac illness\n* Severe neurological disorders\n* Immunological or systemic illness\n* Having psychiatric disorders\n* Alcohol\u002Fdrug\u002Fsubstance use",{"count":306,"type":22},"Schizoaffective disorder (SAD) is a chronic psychiatric condition characterized by psychotic and mood symptoms. Emerging evidence suggests that Leucine-Rich Repeat and Fibronectin Type-III Domain-Containing Protein 5 (LRFN5) and olfactomedin-4 (OLFM4) may play roles in synaptic organization, neurodevelopment, and neuroinflammation. However, no prior study has investigated these biomarkers in SAD. This cross-sectional case-control study aims to compare peripheral serum levels of LRFN5 and OLFM4 in subjects diagnosed with SAD in remission and healthy control subjects. The study also assessed associations between these biomarkers and clinical symptom severity, global functioning, and systemic inflammation measured by the Aggregate Index of Systemic Inflammation (AISI). The study aimed to investigate convergent synaptic and immunoinflammatory dysregulation in SAD.",[29],[29,491,492,422,493],"LRFN5","OLFM4","Neuroinflammation","2026-02-26",{"date":496,"type":40},"2026-03-04",{"date":498,"type":22},"2026-03-02",{"date":137,"type":22},{"name":501,"class":502},"Elazığ Mental Health and Diseases Hospital","OTHER_GOV",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":168},"100521612","enhanced-coordinated-specialty-care-for-early-psychosis-100521612","NCT06071858","Enhanced Coordinated Specialty Care for Early Psychosis","Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis","Inclusion Criteria:\n\n* People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:\n* McLean Hospital OnTrack (OnTrack Clinic)\n* Massachusetts General Hospital (FEPP Clinic)\n* Boston Medical Center (WRAP Clinic)\n* Cambridge Health Alliance (RISE Clinic)\n* UMass Memorial Health Care (STEP Clinic)\n* ServiceNet (PREP West)\n\nExclusion Criteria:\n\n* None",{"count":511,"type":22},350,[61],"The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:\n\n• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?\n\nParticipants will either:\n\n* Receive care as usual (CSC) or\n* Receive care as usual (CSC) plus five additional care elements (CSC 2.0):\n\n  1. Individual peer support\n  2. Digital outreach\n  3. Care coordination\n  4. Multi-family group therapy\n  5. Cognitive remediation\n\nResearchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.",[123,64,29,515,93],"Psychosis Nos\u002FOther",[517,518],"first episode psychosis","early psychosis","2026-02-25",{"date":521,"type":40},"2026-02-27",{"date":523,"type":40},"2024-02-01",{"date":525,"type":22},"2028-10",{"name":374,"class":47},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":538,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":48},"100582640","context-aware-mobile-intervention-for-social-recovery-in-serious-mental-illness-r33-100582640","NCT06865937","Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)","Inclusion Criteria:\n\n* Voluntary informed consent to participate and capacity to consent; Age 18 to 65;\n* Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;\n* Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;\n* Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).\n\nExclusion Criteria:\n\n* Prior cognitive-behavioral therapy in the past 2 years;\n* Greater than moderate disorganization on the PANSS (P2- Disorganization item \\>5);\n* Alcohol or substance dependence in past 3 months based on the diagnostic interview;\n* Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);\n* Unable to adequately see or manually manipulate a phone;\n* Resident of an integrated housing facility that also provides treatment services.",{"count":534,"type":22},125,[61],"This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.",[28,29],[314,66,539,67],"social engagement","2026-02-20",{"date":542,"type":40},"2026-02-23",{"date":544,"type":40},"2025-07-01",{"date":546,"type":22},"2028-09-30",{"name":79,"class":47},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":198,"sex":17,"minAge":407,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":48},"100559321","phase-4-anticholinergic-deprescription-in-schizophrenia-100559321","NCT06562608","Anticholinergic Deprescription in Schizophrenia","Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum","Inclusion Criteria:\n\n1. Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).\n2. Prescription of benztropine or trihexyphenidyl for at least 6 months\n3. Age 40-70 years.\n4. ACBS score \\>= 3.\n5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).\n6. Competency and willingness to sign informed consent.\n\nInclusion criteria for the healthy control group:\n\n1. Age 40-70 years.\n2. Competency and willingness to sign informed consent.\n\nExclusion Criteria:\n\n1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,\n2. Serious neurologic or medical condition\u002Ftreatment that impacts the brain and Neurodegenerative conditions such as Parkinson's, dementia, etc.; autoimmune conditions such as Multiple Sclerosis (MS) and lupus; as well as traumatic brain injury (TBI).\n3. Significant risk of suicidal or homicidal behavior.\n4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.\n5. Contraindications for MR imaging (e.g., a pacemaker).\n6. Current SCID-verified substance use disorder will be excluded to avoid the confounding impact of significant substance use comorbidity. Participants with a history of substance use disorder that is in early or full remission will be eligible, to enhance generalizability.\n7. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.\n\nExclusion criteria for Healthy Control (HC) subjects:\n\n1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.\n2. Score greater than 1 on the ACB scale.\n3. MR imaging contraindications.\n4. Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.\n5. HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.\n6. Individuals currently taking anticholinergic medications for reasons other than SSD.","70 Years",{"count":557,"type":22},105,[25],"In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognition in individuals who with schizophrenia. Individuals identified by clinical services who have unneeded prescriptions benztropine or trihexyphenidyl will be eligible for deprescription and study entry. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will will be randomized to either staying on their anticholinergic drugs or undergoing deprescription per routine clinical care, and will undergo follow-up evaluations across 6 months. The investigators predict that reducing and deprescribing these drug, if clinically determined to be unnecessary will will enhance functioning, neurocognition",[64,29],"2026-02-05",{"date":563,"type":40},"2026-02-09",{"date":565,"type":40},"2025-02-01",{"date":567,"type":22},"2029-06-30",{"name":271,"class":47},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":80},"100567776","magnetic-seizure-therapy-for-schizophrenia---trial-100567776","NCT06672588","Magnetic Seizure Therapy for Schizophrenia - Trial","MAST","Inclusion Criteria:\n\n1. are inpatients or outpatients;\n2. demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);\n3. have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);\n4. are 18 years of age or older;\n5. have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;\n6. have a BPRS score at baseline of at least moderate severity (\\>4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;\n7. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;\n8. are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;\n9. are able to adhere to the intervention schedule;\n10. meet the MST safety criteria;\n11. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.\n\nExclusion Criteria:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;\n2. have a concomitant major unstable medical illness;\n3. are pregnant or intend to get pregnant during the study;\n4. have probable dementia based on study investigator assessment;\n5. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;\n6. present with a serious medical condition,\n7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n8. require a benzodiazepine with a dose \\> lorazepam 2 mg\u002Fday or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;\n9. are unable to communicate in English fluently enough to complete the neuropsychological tests;\n10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).",{"count":577,"type":22},80,[61],"This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).",[581,64,29],"Treatment Resistant Schizophrenia",[64,29,581,583,584,585],"Electroconvulsive Therapy","Magnetic Seizure Therapy","Convulsive Therapy",{"date":587,"type":40},"2026-02-03",{"date":589,"type":40},"2025-04-22",{"date":591,"type":22},"2028-11",{"name":593,"class":47},"Centre for Addiction and Mental Health",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":601,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":608,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":48},"100561131","enhancing-rehabilitation-for-veterans-with-serious-mental-illness-100561131","NCT06586164","Enhancing Rehabilitation for Veterans With Serious Mental Illness","Enhancing Rehabilitation for Veterans With Serious Mental Illness Via Biomarker-Informed Cognitive Training","Inclusion Criteria:\n\n* Veterans with SMI (e.g., schizophrenia, schizoaffective disorder, bipolar disorder, PTSD) being treated at PRRCs or co-located rehabilitative services.\n* Age 18 and 83 years.\n* Fluency in spoken and written English.\n* Ability to detect 1000 Hz tones binaurally at a 40-dB sound pressure level.\n* Ability to see with an acuity of 20\u002F40 with both eyes tested together (corrected if applicable) by a standard printed Snellen eye chart reading card.\n\nExclusion Criteria:\n\n* Estimated premorbid IQ below 70, as estimated via the WRAT-4 Reading subtest.\n* Active substance use other than cannabis within the last 30 days as determined by CPRS review, self- report, or positive urine drug screen (obtained as part of the screening process).\n* History of significant medical or neurological illness.\n* Inability to comprehend or provide informed consent.","83 Years",{"count":577,"type":22},[61],"This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.",[64,123,606,607,29,93],"Serious Mental Illness","PTSD",[314,233,609,610,611,607,612,613,614,615],"cognition","EEG","Serious mental illness","Schizoaffective disorder","Bipolar disorder","clinical symptoms","function","2026-01-28",{"date":475,"type":40},{"date":619,"type":40},"2025-02-25",{"date":621,"type":22},"2028-10-31",{"name":248,"class":249},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":630,"maxAge":57,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":649,"locationsCount":168},"100538082","integrative-neuro-social-cognitive-strategy-programme-for-instilling-recovery-inspire-a-community-based-cognitive-remediation-trial-100538082","NCT06286202","Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial","Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial","Inclusion Criteria:\n\n* A diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).\n* Completed at least ten years of formal education with English as the main instructional language. Participants need to be able to converse in English and understand English instructions, as the cognitive remediation program will be conducted in English.\n\nExclusion Criteria:\n\n* Known neurological diseases and epilepsy, which affects gains from cognitive remediation.\n* Unable to speak and understand English.\n* Hospitalized within the past one month.\n* Global Assessment of Functioning score of 30 or below, as participants who are too low functioning are unable to benefit from a strategy learning approach.","21 Years",{"count":632,"type":22},160,[61],"Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied.\n\nTherefore, the aims of the study are:\n\n* To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings.\n* To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability.\n\nParticipants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers.\n\nThis research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later.",[64,29],[637,638,639,640,641,314,642],"cognitive remediation","Neuropsychological and Educational Approach to Remediation","Multicontext Treatment Approach","metamotivation","psychiatric rehabilitation","community mental health","2026-01-25",{"date":645,"type":40},"2026-01-27",{"date":647,"type":40},"2024-08-06",{"date":294,"type":22},{"name":650,"class":47},"Singapore Institute of Technology",{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":664,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":4},"100621743","impact-of-medication-education-on-adherence-and-side-effects-100621743","NCT07374588","Impact of Medication Education on Adherence and Side Effects","The Effect of Medication Education on Treatment Adherence and Side Effects in Psychiatric Inpatients: An Intervention Study","MED-ADHERE","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Hospitalized in a psychiatric inpatient clinic\n* Diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, or major depressive disorder with psychotic features\n* Receiving psychotropic medication treatment\n* Clinically stable and able to participate in educational sessions\n* Able to communicate verbally and understand the content of the education\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Presence of severe cognitive impairment or intellectual disability\n* Acute medical or neurological conditions that may interfere with participation\n* Severe agitation or acute psychotic symptoms preventing participation\n* Hearing or communication impairments that limit participation in educational sessions\n* Participation in another psychosocial intervention study during the study period",{"count":660,"type":22},64,[61],"Severe mental disorders such as schizophrenia, bipolar disorder, and psychotic depression often require long-term or lifelong medication treatment. However, many psychiatric patients have difficulty adhering to their prescribed medication regimens due to factors such as lack of information, fear of side effects, and negative experiences with psychotropic medications. Poor treatment adherence is associated with symptom relapse, prolonged hospitalization, increased rehospitalization rates, reduced quality of life, and higher health care costs.\n\nMedication education is a key psychosocial intervention aimed at improving patients' understanding of their illness, treatment process, and potential medication side effects. Providing structured medication education may enhance treatment adherence and help patients recognize and manage side effects more effectively.\n\nThis intervention study aims to evaluate the effect of a structured medication education program on treatment adherence and medication-related side effects among psychotic inpatients hospitalized in a psychiatric clinic, including patients diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, and major depressive disorder with psychotic features. The findings of this study are expected to contribute to the development of effective psychosocial interventions to improve medication adherence and treatment outcomes in psychiatric inpatient settings.",[64,29,126,125],[665,666,667,668,669],"Medication Education","Psychiatric Inpatients","Psychoeducation","Treatment Adherence","Medication Side Effects","2026-01-24",{"date":672,"type":40},"2026-01-29",{"date":674,"type":22},"2026-01-02",{"date":676,"type":22},"2026-06-02",{"name":678,"class":47},"Cumhuriyet University"]