[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,237,0,25,[9,49,76,95,129,153,180,203,223,243,269,291,314,337,365,393,412,431,458,484,509,534,554,577,599],{"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":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053742","the-effect-of-comorbid-alcoholsubstance-use-100053742",false,"NCT07692984","The Effect of Comorbid Alcohol\u002FSubstance Use","The Effect of Comorbid Alcohol\u002FSubstance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Having a diagnosis of Schizophrenia Spectrum Disorder and Other Psychotic Disorders or Bipolar Disorder according to DSM-5 diagnostic criteria,\n* Being actively followed up at the TRSM for at least 6 months.\n\nExclusion Criteria:\n\n* Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),\n* Individuals with severe cognitive impairment that prevents them from communicating adequately.","ALL","18 Years","65 Years",{"count":21,"type":22},297,"ESTIMATED","OBSERVATIONAL","Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions.\n\nAim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use.\n\nResearch Questions\n\nWhat are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD?\n\nHypotheses\n\nH1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use.\n\nH2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group.\n\nH3: Social inclusion is lower among patients with substance use compared with the control group.\n\nH4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone.\n\nH5: Substance use negatively affects patients' social participation, including involvement in activities and friendships.\n\nH6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.",[26,27,28,29,30,31,32],"Alcohol Abuse","Alcohol Use Disorder","Substance Use Disorders","Severe Mental Disorder","Schizophrenia","Bipolar Disorder","Ostracism",[34,28,29,35],"alcohol use disorder","ostracism","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2026-06-20",{"date":44,"type":22},"2026-12-30",{"name":46,"class":47},"Abant Izzet Baysal University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100615127","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-karxt-for-the-treatment-of-schizophrenia-in-adolescents-emergent-teen-100615127","NCT07288567","A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)","A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)","Inclusion Criteria:\n\n* Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).\n* PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).\n* Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.\n* Any neurological disorder, except for Tourette's Syndrome.\n* Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","13 Years","17 Years",{"count":59,"type":22},166,"INTERVENTIONAL",[62],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.",[30],"2026-06-29",{"date":67,"type":40},"2026-06-30",{"date":69,"type":40},"2026-01-29",{"date":71,"type":22},"2029-12-18",{"name":73,"class":74},"Bristol-Myers Squibb","INDUSTRY",44,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":83,"targetDuration":4,"studyType":60,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100583934","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-karxt-in-acutely-psychotic-japanese-adult-participants-with-schizophrenia-100583934","NCT06882785","A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia","A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia","Inclusion Criteria\n\n* Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).\n* Participants must have a PANSS total score between 80 and 120, inclusive.\n* Participants must have a CGI-S score of ≥ 4.\n\nExclusion Criteria\n\n* Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.\n* Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.\n* Participants must not have any history or presence of clinically significant medical conditions.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":84,"type":22},250,[62],"The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia",[30],{"date":67,"type":40},{"date":90,"type":40},"2025-06-10",{"date":92,"type":22},"2029-08-23",{"name":73,"class":74},56,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":60,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":48},"100451370","exercise-based-program-for-rehabilitation-of-veterans-with-severe-mental-illness-100451370","NCT05157620","Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness","ESHANTI","Inclusion Criteria:\n\n* Written informed consent;\n* age 18-70 years;\n* DSM-5 diagnosis of\n\n  * schizophrenia,\n  * schizoaffective disorder,\n  * bipolar 1 disorder,\n* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder including those with a co-morbid\n\n  * alcohol use disorder or substance use disorder;\n  * clinically stable;\n* clinical global impression-severity (CGI-S) scores mild to moderately ill\n\nExclusion Criteria:\n\n* Unable to provide written informed consent;\n* intellectual disability (i.e., severe enough to impact understanding of yoga-based exercises) based on chart or IQ\\\u003C80 on the Wechslet Abbreviated Scale of Intelligence-II (WASI-II);\n* disability or illness precluding yoga-based exercises or wellness lifestyle program, e.g.,\n\n  * current or recent angina (\\\u003C6 months),\n  * history of myocardial infarction in the past year (unless permission is obtained from the primary care physician),\n  * uncontrolled hypertension or hypotension;\n* neurological illness complicating diagnosis \u002F cognitive evaluation, e.g.,\n\n  * dementia,\n  * stroke or head injury;\n* physical problems that preclude training for yoga-based exercises \u002F wellness lifestyle program, e.g.,\n\n  * severely impaired vision;\n  * ongoing treatment that includes more than one hour per week of relaxation and mind-body based stress reduction strategies related to yoga","70 Years",{"count":104,"type":22},112,[106],"NA","This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.",[30,109,110],"Schizoaffective","Bipolar Disorder 1",[112,113,114,115,116,117,118,119],"schizophrenia","psychotic disorders","schizoaffective","bipolar disorder 1","exercise","yoga","community function","quality of life",{"date":121,"type":40},"2026-07-01",{"date":123,"type":40},"2022-10-24",{"date":125,"type":22},"2026-12-31",{"name":127,"class":128},"VA Office of Research and Development","FED",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":60,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100645322","phase-2-study-to-evaluate-the-safety-and-efficacy-of-ublituximab-in-participants-with-schizophrenia-100645322","NCT07680946","Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia","Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia","Inclusion Criteria:\n\n1. Primary diagnosis of schizophrenia.\n2. Treatment-resistant.\n3. Requires antipsychotic treatment and is currently receiving \"standard of care\".\n4. PANSS total score between 80 and 120, inclusive at screening and baseline.\n\nExclusion Criteria\n\n1. Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia.\n2. Ongoing clozapine treatment.\n3. Risk for suicidal behavior.\n4. Any severe or uncontrolled medical condition that could affect the participant's ability to participate.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply","60 Years",{"count":138,"type":22},60,[140],"PHASE2","The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by positive and negative syndrome scale (PANSS) total score in participants with schizophrenia.",[30],"NOT_YET_RECRUITING","2026-06-26",{"date":146,"type":40},"2026-07-02",{"date":148,"type":22},"2026-07-06",{"date":150,"type":22},"2029-03-01",{"name":152,"class":74},"TG Therapeutics, Inc.",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":60,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":48},"100645252","overnight-thalamic-tes-ti-to-modulate-sleep-spindles-in-individuals-with-schizophrenia-spectrum-disorders-and-matched-healthy-controls-100645252","NCT07680114","Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls","A Pilot Feasibility Study of Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls","ONSETS","Inclusion Criteria (all participants):\n\n* U.S. citizen or holding permanent resident status\n* English-speaking\n\nInclusion Criteria (Participants with SSD):\n\n* DSM-5 schizophrenia spectrum disorder (SSD) diagnosis, defined as schizophrenia, schizoaffective disorder, or schizophreniform disorder (confirmed by clinical interview and\u002For chart review)\n* Chronic illness, defined as diagnosis of SSD for at least 1 year\n* Clinically stable outpatient (no psychiatric hospitalization in past 6 months; no change in antipsychotic medication in the past 6 weeks)\n\nInclusion Criteria (Healthy Controls):\n\n* Medically healthy (based on self-report and study team review)\n* Matched to SSD participants on age (±5 years) and sex\n\nExclusion Criteria (all participants):\n\n* Current or past history of clinically significant neurological disorder or acquired neurological disease (e.g., stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified on the structural MRI)\n* Active suicidal ideation, plan, or intent (assessed via PHQ-9 item 9 and follow-up Columbia-Suicide Severity Rating Scale (C-SSRS) Screener; see Safety Response Procedure)\n* Inability to provide informed consent, including inadequate decisional capacity in the judgment of the study team and\u002For study psychiatrist\n* History of head trauma resulting in prolonged loss of consciousness; or a history of \\>3 grade I concussions\n* Current poorly controlled headaches, including intractable or frequent migraines\n* Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n* Possible pregnancy or plan to become pregnant in the next 6 months (self reported)\n* Any metal in the head\n* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)\n* Dental implants\n* Permanent retainers\n* Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions\n* Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions\n* Current use of medications known to substantially lower seizure threshold, specifically chlorpromazine, clozapine, bupropion, clomipramine, or maprotiline; or other medications at doses known to substantially lower seizure threshold in the judgment of the PI or Study Psychiatrist\n* Current use of medications known to directly and substantially enhance sleep spindle activity, including benzodiazepines; non-benzodiazepine \"Z-drug\" hypnotics (zolpidem, eszopiclone, zaleplon); barbiturates; and gabapentin or pregabalin, within 2 weeks of the overnight study visits. Other sedating medications used as sleep aids (e.g., trazodone, hydroxyzine, mirtazapine) are permitted provided the regimen is stable across the two overnight visits; dose and timing will be recorded as covariates\n* Current moderate-to-severe alcohol or other substance use disorder (DSM-5) other than nicotine or caffeine\n* Active scalp lesions, broken skin, or skin conditions at planned electrode sites that would preclude safe electrode application\n* Claustrophobia (a fear of small or closed places)\n* Back problems that would prevent lying flat for up to two hours\n* Regular night-shift work (second or third shift)\n* Sleep apnea or other sleep disorder (self-reported)\n\nExclusion Criteria (Healthy Controls):\n\n* Self-reported history of inpatient psychiatric hospitalization\n* Self-reported current or past diagnosis of schizophrenia or any other psychotic disorder\n* Self-reported first-degree relative with schizophrenia or any other psychotic disorder\n* Self-reported current or past diagnosis of bipolar disorder or major depressive disorder with psychotic features, or current treatment for any psychiatric disorder other than depression or anxiety (handled via the medication rule below)\n* Current use of any psychotropic medication, with the exception of a single SSRI or SNRI taken at a stable dose for at least 6 weeks for depression or anxiety. Current use of antipsychotics, tricyclic antidepressants, mirtazapine, trazodone, lithium or other mood stabilizers, benzodiazepines, non-benzodiazepine hypnotics, other anxiolytics, or stimulants will result in exclusion.",true,"50 Years",{"count":164,"type":22},20,[106],"This study to find out whether a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity during sleep-especially sleep spindles (brain rhythms in the \\~8-16 Hz range). The investigators are focusing on the thalamus, a deep brain region that helps coordinate brain activity during non-REM sleep. Sleep spindles are often reduced in schizophrenia, so this study is to see whether TES-TI can change spindle activity in individuals with schizophrenia spectrum disorders (SSD) and in healthy adults. To study this, a structural MRI scan will be used to customize where the stimulation electrodes are placed, and then TES-TI will be applied during one of two overnight sleep lab visits while brain activity is recorded with high-density EEG and standard sleep sensors. The other overnight is a baseline\u002Fcontrol night during which only sham stimulation is delivered. The goal is to determine whether TES-TI during sleep can increase spindle-frequency activity in this population.",[30],[169,170,171],"schizophrenia spectrum disorders","sleep spindles","transcranial electrical stimulation with temporal interference","2026-06-25",{"date":146,"type":40},{"date":175,"type":22},"2026-08",{"date":177,"type":22},"2027-12",{"name":179,"class":47},"University of Wisconsin, Madison",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":188,"targetDuration":4,"studyType":60,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100628926","phase-2-study-to-assess-the-safety-tolerability-and-treatment-response-of-gxv813-in-hospitalized-adults-with-schizophrenia-100628926","NCT07467993","Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia","A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)","STAR-1","Inclusion Criteria:\n\n1. Participant is aged 18 to 65 years, inclusive, at screening\n2. Participant is capable of providing informed consent\n3. Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)\n4. Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements\n5. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening\n\n   1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms\n   2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening\n6. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:\n\n   i. Item 1 (P1; delusions)\n\nii. Item 2 (P2; conceptual disorganization)\n\niii. Item 3 (P3; hallucinatory behavior)\n\niv. Item 6 (P6; suspiciousness\u002Fpersecution)\n\nExclusion Criteria:\n\n1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)\n2. History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia\n3. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded\n4. Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":189,"type":22},142,[140],"The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia",[30],[30,194],"GVX813",{"date":144,"type":40},{"date":197,"type":40},"2026-03-16",{"date":199,"type":22},"2027-07-29",{"name":201,"class":74},"Novartis Pharmaceuticals",12,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":210,"targetDuration":4,"studyType":60,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":48},"100585980","mobile-thinking-intervention-a-inital-test-100585980","NCT06909422","Mobile Thinking Intervention: A Inital Test","A Mobile Intervention to Enhance Your Mood: A Test of the Acceptability and Efficacy","Inclusion Criteria:\n\n* Diagnosis of schizophrenia or related psychotic disorder OR\n* Identified as being at clinical high risk for psychosis in symptom interviews\n\nExclusion Criteria:\n\n* Recent changes in mental health treatment in past month or two months if on depot",{"count":211,"type":22},100,[106],"This study will test the inital efficacy of a brief mobile intervention targeting biased thinking.",[30,215],"Clinical High Risk for Psychosis (CHR)",{"date":65,"type":40},{"date":218,"type":22},"2026-12",{"date":220,"type":22},"2028-12",{"name":222,"class":47},"University of Alabama at Birmingham",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":230,"targetDuration":4,"studyType":60,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100584811","phase-3-a-trial-of-the-efficacy-and-safety-of-sep-363856-in-acutely-psychotic-participants-with-schizophrenia-100584811","NCT06894212","A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","Key Inclusion Criteria:\n\n* Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.\n* Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).\n* Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening\n\n  1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.\n  2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.\n* Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:\n\n  1. Participant must have a PANSS total score ≥ 80\n\n     AND\n  2. Participant must have a CGI-S score ≥ 4.\n* Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.\n\nKey Exclusion Criteria:\n\n* Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.\n* Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.\n* Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.\n* Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study",{"count":231,"type":22},522,[62],"Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia",[30],{"date":67,"type":40},{"date":237,"type":40},"2025-02-28",{"date":239,"type":22},"2026-10-29",{"name":241,"class":74},"Otsuka Pharmaceutical Development & Commercialization, Inc.",73,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":60,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":48},"100465409","patientheque-in-patients-with-a-psychosis-100465409","NCT05340348","Patientheque in Patients With a Psychosis","Formation of a Patientheque in Patients With a Beginner Psychosis","LONGIPEP","Inclusion Criteria:\n\n* Major and or minor aged 15 to 30 assessed within the CEVUP (Consultation for the Assessment of Psychological Vulnerability) and cared for at the psychiatry center as part of a first psychotic episode (Diagnosis CIM 10: F20 -F29 first hospitalization). These patients are referred by care and medico-social partners (general practitioners, school doctors, school nurses, educators, addictologists, psychiatrists\n* \"At risk\" status for psychotic disorder (GRD, APS, BLIPS group) or psychosis threshold during the CAARMS test (psychometric scale for the assessment of psychotic symptoms)\n* Consent of the patient or his legal guardian\n\nExclusion Criteria:\n\n* History of psychosis for more than one year\n* \"Not at risk\" status for psychotic disorder on the CAARMS (psychometric scale for the assessment of psychotic symptomatology)\n* IQ\\\u003C70 (WAIS)\n* Neurological disorder or other health problem that may explain the disorders\n* Refusal to participate - History of psychosis for more than one year","15 Years","30 Years",{"count":84,"type":22},[106],"Establishment of a patient library for patients who have had a first psychotic episode and who have an \"at risk\" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.",[257,258,30],"Schizophrenia Prodromal","Schizophrenia, Childhood",[30,260],"Patient library","2026-06-24",{"date":144,"type":40},{"date":264,"type":40},"2022-07-25",{"date":266,"type":22},"2032-07-25",{"name":268,"class":47},"University Hospital, Brest",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":276,"targetDuration":278,"studyType":23,"phases":4,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":48},"100641024","a-20-year-follow-up-of-first-episode-psychosis-longitudinal-effects-of-early-treatment-strategies-and-relapse-100641024","NCT07616999","A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse","Navigating the Longitudinal Effects of Early Treatment Strategies and Relapse on Clinical, Cognitive, and Functional Outcomes: A 20-Year Follow-up of First Episode Psychosis","Participants were individuals who previously participated in a randomized controlled trial investigating medication continuation\u002Fdiscontinuation on relapse during first episode psychosis (ClinicalTrials.gov NCT00334035). The trial included specific inclusion and exclusion criteria, detailed as follows:\n\nInclusion Criteria:\n\n* A diagnosis of schizophrenia or non-affective psychosis (schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, or psychosis not otherwise specified) (DSM-IV)\n* Aged 18 to 65 years at the time of original enrolment\n* Had been treated with antipsychotic drugs for at least 12 months\n* No history of relapse or exacerbation or had to be asymptomatic (free of positive symptoms of psychosis) at study entry.\n\nExclusion Criteria:\n\n* A diagnosis of drug-induced psychosis\n* Current treatment with clozapine, with mood stabilizing medications (lithium, valproate or carbamazepine) or with depot medication\n* Had high risk of suicide or violence\n* Inability to provide informed consent at recruitment",{"count":277,"type":22},178,"20 Years","The study aims to address the following questions:\n\n1. Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes?\n2. What are the long-term cognitive functioning trajectories, what factors predict these trajectories, and how do they relate to outcomes?\n3. What might be the mechanisms behind medication discontinuation and poor long-term outcome, including the roles of multiple relapses and treatment resistance after first-episode psychosis?\n\nEligible patients will be invited to a one-time face-to-face interview. A trained research assistant will guide the participants through questions about their background, clinical symptoms, daily functioning, cognitive abilities, and psychological well-being.",[30],[30,282],"20-year follow up","2026-06-23",{"date":144,"type":40},{"date":286,"type":40},"2026-05-21",{"date":288,"type":22},"2028-12-31",{"name":290,"class":47},"The University of Hong Kong",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":298,"maxAge":57,"enrollmentInfo":299,"targetDuration":4,"studyType":60,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100625574","phase-3-a-study-to-evaluate-the-long-term-safety-and-tolerability-of-karxt-and-karx-ec-for-the-treatment-of-schizophrenia-and-autism-related-irritability-in-adolescents-respectively-100625574","NCT07424404","A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively","A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n\\- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.\n\nExclusion Criteria\n\n* Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of \"Yes\" on Questions 4 or 5 on the suicidal ideation section of the \"Since Last Visit\" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.\n* Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.\n* Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","5 Years",{"count":300,"type":22},400,[62],"The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively",[30,304],"Autism-Related Irritability","2026-06-22",{"date":283,"type":40},{"date":308,"type":40},"2026-04-07",{"date":310,"type":22},"2030-03-08",{"name":312,"class":74},"Karuna Therapeutics, Inc., a Bristol Myers Squibb company",58,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":60,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100624505","phase-2-a-study-of-brenipatide-in-adult-participants-with-schizophrenia-100624505","NCT07410507","A Study of Brenipatide in Adult Participants With Schizophrenia","A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)","RENEW-Scz-1","Inclusion Criteria:\n\n* Meet the diagnostic criteria of schizophrenia\n* Are on a stable standard of care medication regimen for schizophrenia\n* If the duration of illness is \\>6 years, participant has experienced at least one relapse of schizophrenia in last 3 years\n* Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention store and use the provided study intervention as directed,\n  * maintain electronic or paper study diaries, as applicable, and\n  * complete the required questionnaires\n\nExclusion Criteria:\n\n* Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder\n* Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening\n* Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma\n* Are actively suicidal or deemed to be a significant risk for suicide\n* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study","55 Years",{"count":324,"type":22},450,[140],"The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia.\n\nThe trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.",[30],"2026-06-19",{"date":283,"type":40},{"date":331,"type":40},"2026-02-10",{"date":333,"type":22},"2027-11",{"name":335,"class":74},"Eli Lilly and Company",103,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":60,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"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.",{"count":346,"type":22},106,[106],"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.",[30,350],"Schizoaffective Disorder",[30,352,353,354,355],"serious mental illness","randomized clinical trial","executive function training","Cognitive Behavioral Social Skills Training","2026-06-18",{"date":283,"type":40},{"date":359,"type":22},"2026-10-01",{"date":361,"type":22},"2029-06",{"name":363,"class":47},"University of California, San Diego",2,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":322,"enrollmentInfo":372,"targetDuration":4,"studyType":60,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":48},"100641717","frontal-gamma-coherence-neurofeedback-for-patients-with-schizophrenia-100641717","NCT07659938","Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia","Preliminary Placebo-Controlled Double-Blind Randomized Clinical Trial of Mobile Platform to Improve Memory From Home or Office for Patients With Schizophrenia","Inclusion Criteria:\n\n1. Voluntary informed consent to participate and capacity to consent as measured by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC1) instrument;\n2. Age 18 to 55;\n3. Meet DSM-5 criteria for a current diagnosis of schizophrenia or schizoaffective disorder based on a SCID-5 interview and available medical record review;\n4. Clinically stable as operationalized by (a) not having been admitted to a psychiatric hospital within the three months prior to assessment, (b) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (c) ascertained to be clinically and medically stable by one of the study investigators\n\nExclusion Criteria:\n\n1. Electroconvulsive therapy within six months of the baseline assessment;\n2. Medical conditions that can impact cognition, including self-reported history of seizure disorder; multiple sclerosis; stroke or major vascular disease; HIV\u002FAIDS; brain cancer; prior head injury involving loss of consciousness;\n3. Current (but not past) major depression;\n4. Substance use disorder other than nicotine or caffeine in the past year;\n5. Inability to read or speak English (with corrected vision or hearing if needed);\n6. Unable to adequately see or manually manipulate a smartphone, tablet or other mobile device;\n7. Uncooperativeness with the laboratory assessment protocol leading to missing data;\n8. Color blindness that interferes with assessment;\n9. Testing in the past 6 months on the cognitive measures",{"count":373,"type":22},30,[106],"This preliminary, randomized, double-blind, placebo-controlled clinical trial will evaluate frontal gamma coherence neurofeedback in adults with schizophrenia. Thirty participants will be randomly assigned to receive either active neurofeedback or placebo neurofeedback using a study-provided mobile platform. Participants will complete baseline assessments in person at the University of California San Diego, receive training on home use of the neurofeedback platform, and complete twice-weekly 30-minute sessions at home for 12 weeks. Participants will return for midpoint and end-of-treatment assessments to evaluate feasibility, tolerability, cognitive outcomes, and neurophysiological target engagement.",[30,109],[112,378,379,380,381,382,383,384],"working memory","gamma","EEG","neurofeedback","mobile","digital","neurotechnology","2026-06-17",{"date":305,"type":40},{"date":388,"type":22},"2027-04",{"date":390,"type":22},"2028-06",{"name":392,"class":74},"BioSignal Solutions LLC",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},"100622146","effectiveness-and-adverse-effect-switch-evaluation-of-xanomeline-and-trospium-chloride-karxt-100622146","NCT07379827","Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)","Effectiveness and Adverse-effect Switch Evaluation","Inclusion Criteria:\n\n* Participants (or caregiver\u002Flegal guardian) must have signed and dated an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.\n* Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.\n* Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:\n\n  * Be within \\\u003C16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR\n  * On a stable regimen (dose and frequency consistent with the drug label and\u002For at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and\u002For efficacy will be made independently by the treating clinician and\u002For the patient and is not dictated by the study. Participants can be enrolled during tapering\u002Fdiscontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.\n* Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.\n\nExclusion Criteria:\n\n* Prior use of KarXT that has been discontinued for any reason prior to Baseline.\n* Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.\n* Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.\n* In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are \\\u003C 16 weeks from initiation of KarXT.\n* Participants who are pregnant, planning to become pregnant, or breastfeeding.",{"count":401,"type":22},1500,"The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States",[30],[30],{"date":356,"type":40},{"date":407,"type":40},"2026-02-26",{"date":409,"type":22},"2028-06-20",{"name":73,"class":74},52,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},"100600715","evaluation-of-treatment-satisfaction-and-karxt-utilization-registry-resku-100600715","NCT07101094","Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)","Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)","Inclusion Criteria:\n\n* Aged ≥18 years at index date.\n* Have a confirmed diagnosis of schizophrenia before index date.\n* Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.\n* Provide a signed and dated Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.\n* Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).\n* English or Spanish speaking.\n\nExclusion Criteria:\n\n* Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.\n* Evidence of use of XT prior to time of eligibility screening.",{"count":420,"type":22},300,"The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X\u002FT) therapy",[30],[30],{"date":356,"type":40},{"date":426,"type":40},"2025-09-22",{"date":428,"type":22},"2029-05-14",{"name":73,"class":74},18,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":60,"phases":440,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":457},"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":439,"type":22},50,[441],"PHASE4","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.",[30,350,31,444,445],"Major Depressive Disorder","Tardive Dyskinesia",[447],"Valbenazine","2026-06-15",{"date":450,"type":40},"2026-06-16",{"date":452,"type":40},"2025-08-29",{"date":454,"type":22},"2027-01",{"name":456,"class":74},"Neurocrine Biosciences",22,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":278,"maxAge":322,"enrollmentInfo":465,"targetDuration":4,"studyType":60,"phases":467,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":48},"100542278","phase-2-neurotransmitters-in-treatment-resistant-schizophrenia-patients-with-add-on-sodium-benzoate-100542278","NCT06340789","Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate","Functional Connectivity and Associated Neuropeptides Variations in Treatment Resistant Schizophrenia Patients: Treatment Efficacy of add-on Sodium Benzoate","Inclusion Criteria:\n\n1. Fulfil the DSM5 criteria for schizophrenia or schizoaffective disorder\n2. Research criteria for treatment resistance: little or no symptomatic response to multiple (at least two) antipsychotic treatment of an adequate duration (at least 6 weeks) and adequate doses (equivalent to at least 600 milliequivalent (meq)\u002Fday of chlorpromazine)\n3. 6 month period without remission (i.e. ≥4 item-score for the positive symptoms on PANSS scale , especially delusional thoughts, conceptual disorganisation, excitements, grandiosity, hallucinatory behaviour, excitement, persecution, and hostility)\n4. The persistence of illness was defined as a score of ≥4 (moderately ill) on the severity of illness subscale of the Clinical Global Impression scale (CGI-S), and a lack of stable period of good social occupational function.\n\nExclusion Criteria:\n\n1. Current or previous diagnosis of concurrent DSM-5 disorder due to active medical problems, known neurological disease, or a contraindication to MRI scanning\n2. Current diagnosis of substance-related disorder\n3. Any acute or chronic medical condition\n4. History of head trauma or neurological diseases.",{"count":466,"type":22},90,[140],"Although antipsychotic is effective for schizophrenia, however, still certain proportion of patients were not responsive to treatment. Treatment resistant schizophrenia (TRS) is accompanied by function decline and heavy burden. In recent decades, the biological mechanism of schizophrenia extended from dopamine theory to the role of glutamate system. This shift could be an alternative pathway to developing the treatment of TRS. Sodium benzoate (SB) could be an option as a glutamatergic agent for the patients with TRS. However, most evidence of SB is for treating patients with schizophrenia and other mental disorders but the evidence for treating patients with TRS is scarce. To predict the treatment response of SB will be an urgent topic in the future. Little is known about the precise medicine for treating patients with TRS. The present project will extend our pilot randomized clinical trial on SB for TRS. A total of 90 patients with TRS will be enrolled from three centers and will be assigned to 8 weeks of treatment with SB or placebo (2:1). A comprehensive battery of potential markers will be employed, including 1H- magnetic resonance spectroscopy (MRS), brain functional connectivity, genotyping, immune biomarkers, cognitive function, and clinical characteristics. The efficacy of SB on TRS will be confirmed in this project. Predictors for treatment response will be identified. Artificial intelligence algorithms will be used for probing the feasibility of precision medicine.",[470,30,471],"Symptom, Cognitive","Schizo Affective Disorder",[112,473,474,475],"sodium benzoate","cognition","treatment resistant schizophrenia","2026-06-14",{"date":450,"type":40},{"date":479,"type":40},"2021-11-18",{"date":481,"type":22},"2028-04-30",{"name":483,"class":47},"National Cheng-Kung University Hospital",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":493,"studyType":23,"phases":4,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":507,"locationsCount":48},"100641351","exploring-the-genetics-of-schizophrenia-in-manitoba-100641351","NCT07656870","Exploring the Genetics of Schizophrenia in Manitoba","Uncovering Schizophrenia Genetics Through Whole Genome Sequencing Across Manitoba","GENES-MB","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Reside in Manitoba,\n* Involved in the EPPIS, STEP, PACT, ACT\u002FFACTT clinics,\n* Clinical diagnosis of schizophrenia using standard DSM-5 criteria,\n* Previously consented and enrolled in the MPR.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria beyond meeting the inclusion criteria or not providing informed consent.",{"count":401,"type":22},"1 Year","Schizophrenia is a serious mental illness that affects about 1 in 100 Canadians, shortens life expectancy, and places a large burden on individuals, families, and the healthcare system. Genetics are known to play a major role, but current research explains only part of the inherited risk because most studies have looked at only a small portion of the genome and have mainly focused on people outside Canada. This project will create the first large-scale Manitoba-based schizophrenia whole-genome sequencing database by studying 1,500 Manitobans with and without schizophrenia using both short-read and advanced long-read genome sequencing technologies. Researchers will combine genetic data with lifelong provincial health records to better understand rare genetic variants linked to schizophrenia and how genetic differences influence medication response, side effects, hospitalizations, and treatment outcomes. The study aims to fill important gaps in schizophrenia research in Canada, improve understanding of the disorder's biology, and support the development of more personalized and effective treatments for people living with schizophrenia.",[30,496],"Healthy (Controls)",[112,498,499,500,501],"genetics","saliva","genome","sequencing","2026-06-12",{"date":356,"type":40},{"date":175,"type":22},{"date":506,"type":22},"2031-04",{"name":508,"class":47},"University of Manitoba",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":322,"enrollmentInfo":516,"targetDuration":4,"studyType":60,"phases":518,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},"100597653","phase-1-a-study-to-evaluate-the-safety-tolerability-and-pk-of-an-injectable-form-of-karxt-100597653","NCT07061288","A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT","An Open-label, Phase 1, Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long-Acting Injectable KarXT Formulation in Participants With Schizophrenia","Inclusion Criteria\n\n* Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2).\n* Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline.\n* Participants must have a body mass index (BMI) between 18 and 40 kg\u002Fm².\n* Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements.\n\nExclusion Criteria\n\n* Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia.\n* Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder.\n* Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results.\n* Participants must not be at risk for suicidal behavior.\n* Female participants must not be pregnant or breastfeeding.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":517,"type":22},116,[519],"PHASE1","A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia",[30],[523,524,525],"KarXT","Long-acting injectable (LAI)","Cobenfy","2026-06-11",{"date":502,"type":40},{"date":529,"type":40},"2025-09-03",{"date":531,"type":22},"2027-10-15",{"name":73,"class":74},8,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":60,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":552,"locationsCount":48},"100442069","efficiency-assessment-of-breform-a-multicentric-stepped-wedge-randomized-control-trial-100442069","NCT05036590","Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.","Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.","BREFORM","Inclusion Criteria:\n\n* people over 18yo\n* first-degree relatives (parents, siblings, children) or spouse of the patient\n* primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)\n* consenting to participate to the study\n\nExclusion Criteria:\n\n* mental disorder on Axis I\n* having already benefited from a family intervention such as psychoeducation\n* caring for several people with severe psychiatric disorders\n* receiving income for the caring activities\n* being legally responsible of the patient\n* having difficulty understanding fluent French\n* illiterate",{"count":543,"type":22},206,[106],"In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.\n\nCurrently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.",[30],"2026-06-10",{"date":502,"type":40},{"date":550,"type":40},"2022-04-05",{"date":125,"type":22},{"name":553,"class":47},"Hôpital le Vinatier",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":60,"phases":565,"briefSummary":566,"conditions":567,"keywords":568,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":48},"100380712","french-source-monitoring-task-100380712","NCT04237155","French Source-monitoring Task","Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols","SOUMO","Inclusion Criteria:\n\n* Men and Women aged between 18 and 45\n* Having given their written informed consent\n* Native French speakers\n* Normal or corrected-to-normal vision\n* Education level greater than or equal to 8 (in years)\n* For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of first-degree relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM).\n* For the schizophrenia patients group, meeting the DSM5 criteria for schizophrenia.\n\nExclusion Criteria:\n\n* Do not consent to be included in the study\n* History of hearing impairments\n* People who cannot read\n* Presence of neurological or somatic diseases\n* Being under tutorship or curatorship","45 Years",{"count":564,"type":22},120,[106],"Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.\n\nThe aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.",[30],[569],"Sorce-monitoring","2026-06-09",{"date":526,"type":40},{"date":573,"type":40},"2020-02-07",{"date":575,"type":22},"2027-02-01",{"name":553,"class":47},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":322,"enrollmentInfo":585,"targetDuration":4,"studyType":60,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":533},"100638107","phase-1-a-study-of-the-feasibility-safety-and-tolerability-of-aticaprant-as-adjunctive-treatment-in-participants-with-schizophrenia-100638107","NCT07615426","A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia","A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 1b Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia","KAPPTIVATE1001","Inclusion criteria:\n\n* Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview \\[MINI\\] for psychotic disorders\n* The participant must be on a stable dose of only one atypical antipyschotic medication\n* Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening\n* At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit\n* If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase\n\nExclusion criteria:\n\n* Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on the MINI for psychotic disorders): intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified (NOS), substance-induced psychotic disorder, bipolar disorder, major depressive disorder (recurrent or current episode)\n* Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment)\n* Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire\n* Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES)\n* Has current homicidal ideation\u002Fintent, per the investigator's clinical judgment",{"count":586,"type":22},64,[519],"The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study\u002Fassessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.",[30],"2026-06-04",{"date":592,"type":40},"2026-06-05",{"date":594,"type":40},"2026-03-02",{"date":596,"type":22},"2027-06-21",{"name":598,"class":74},"Janssen Research & Development, LLC",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":606,"targetDuration":4,"studyType":60,"phases":608,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":164},"100610456","phase-3-efficacy-of-nbi-1117568-in-preventing-relapse-in-adults-with-schizophrenia-100610456","NCT07227818","Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia","A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.\n* Participant had the initial diagnosis of schizophrenia ≥1 year before screening.\n* Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.\n\nKey Exclusion Criteria:\n\n* Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \\[including dementing illness, myasthenia gravis\\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1.\n* Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.\n* Participant has a history of clozapine treatment for treatment-resistant psychosis.\n* Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening.\n* Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":607,"type":22},560,[62],"The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.",[30],[30,612],"NBI-1117568",{"date":592,"type":40},{"date":615,"type":40},"2025-12-16",{"date":617,"type":22},"2029-07",{"name":456,"class":74}]