[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizo-affective-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizo-affective-disorder":525},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,76,102,126,149,173,193,219,246,275,299,322,352,379,400,422,454,479,499],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644601","seeg-guided-dbs-for-schizophrenia-100644601",false,"NCT07671261","SEEG-Guided DBS for Schizophrenia","Deep Brain Stimulation for Treatment-Refractory Schizophrenia: Individualized Target Selection and Efficacy","Inclusion Criteria:\n\n* Meets the International Classification of Diseases, 10th Revision (ICD-10) diagnostic criteria for schizophrenia.\n* Male or female, aged 18 to 55 years, with stable vital signs.\n* Currently presents with prominent psychotic symptoms, assessed as moderate or severe by the Positive and Negative Syndrome Scale (PANSS) or other equivalent scales.\n* Exhibits impaired social functioning, assessed as moderate or severe impairment by the Social and Occupational Functioning Assessment Scale (SOFAS) or other equivalent scales.\n* Has a history of sequential treatment with at least two antipsychotic medications of different chemical structures known for strong efficacy against positive symptoms. Treatment must have been at an adequate dose and for an adequate duration (continuous treatment at a therapeutic dose for more than 6 weeks per medication), with good treatment adherence.\n* Has been on a stable antipsychotic medication regimen for at least one month prior to enrollment.\n* Capable and willing to provide written informed consent.\n* Demonstrates good compliance and is able to cooperate with all follow-up procedures.\n\nExclusion Criteria:\n\n* Diagnosed with any psychiatric disorder other than schizophrenia.\n* Presence of a severe personality disorder.\n* History of severe neurological diseases, such as seizures or hemorrhagic stroke.\n* Presence of structural brain abnormalities.\n* Previous history of stereotactic neurosurgery.\n* Contraindications to general anesthesia or stereotactic neurosurgery.\n* Any current or anticipated condition-including medical, psychological, social, familial support, or geographical factors-that might compromise patient safety or interfere with successful participation in the study.","ALL","18 Years","55 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, randomized, interventional study designed to evaluate the efficacy and safety of SEEG-guided deep brain stimulation (DBS) for symptom improvement in patients with treatment-resistant schizophrenia. Using stereo-electroencephalography (SEEG) to record brain activity, we will identify specific abnormal electrophysiological targets and signal features associated with clinical symptoms, followed by a 12-month open-label stimulation period. The study is conducted in three stages: Stage 1 consists of SEEG brain mapping, screening of intervention targets, and optimization of stimulation parameters; Stage 2 consists of DBS implantation surgery and further optimization of stimulation parameters; Stage 3 is a randomized crossover treatment phase, followed by an open-label treatment period.",[27,28],"Schizophrenia Disorders","Schizo Affective Disorder",[30,31,32,33],"Schizophrenia","Stereoelectroencephalography","Neuroimaging","deep brain stimulation","RECRUITING","2026-06-22",{"date":37,"type":38},"2026-06-26","ACTUAL",{"date":40,"type":38},"2025-08-17",{"date":42,"type":21},"2028-12-31",{"name":44,"class":45},"Ruijin Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"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.","20 Years",{"count":56,"type":21},90,[58],"PHASE2","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.",[61,30,28],"Symptom, Cognitive",[63,64,65,66],"schizophrenia","sodium benzoate","cognition","treatment resistant schizophrenia","2026-06-14",{"date":69,"type":38},"2026-06-16",{"date":71,"type":38},"2021-11-18",{"date":73,"type":21},"2028-04-30",{"name":75,"class":45},"National Cheng-Kung University Hospital",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":46},"100552533","feasibility-and-acceptability-of-mobile-mental-health-app-for-sz-and-sza-100552533","NCT06474325","Feasibility and Acceptability of Mobile Mental Health App for SZ and SZA","Feasibility and Acceptability of Mobile Mental Health Application for the Improvement of Medication Adherence in Persons With Schizophrenia(SZ) and Schizoaffective Disorder(SZA)","Inclusion Criteria:\n\n1. Persons diagnosed with schizophrenia and schizoaffective disorder and are in remission for past two months.\n2. Age 18-60 years of any gender.\n3. Able to read and understand Malayalam\u002F English\n\nExclusion Criteria:\n\n1. Patients who have active psychotic or mood symptoms.\n2. History of substance use (except nicotine)\n3. Having any serious physical illness. -","60 Years",{"count":85,"type":21},50,[24],"A new mental health application will be developed for persons with schizophrenia and schizoaffective disorder. The aim is to look at whether it is feasible to use a mobile health application for improving medication adherence in persons with schizophrenia and schizoaffective disorder and whether it is acceptable to that population.",[30,28],[30,28,90,91],"Adherence","Mobile app","NOT_YET_RECRUITING","2026-06-03",{"date":95,"type":38},"2026-06-05",{"date":97,"type":21},"2026-12-01",{"date":99,"type":21},"2028-05-31",{"name":101,"class":45},"University of Pittsburgh",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":109,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":46},"100371255","phase-4-bazedoxifene--treatment-for-women-with-schizophrenia-100371255","NCT04113993","Bazedoxifene -Treatment for Women With Schizophrenia","Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial","Inclusion Criteria:\n\n* Physically well.\n* A current DSM-V diagnosis of schizophrenia or related disorder.\n* 18- 65 years\n* Able to give informed consent.\n* PANSS total score between 40 and 90.\n* Documented normal PAP smear and pelvic examination in the preceding two years.\n* Stable psychotropic medication for previous 4 weeks\n* Normal breast screen (for women aged over 40 years)\n* IQ \\> 70 (as determined by the WAIS IV subtests)\n* English language proficiency (in order to provide informed consent and complete cognitive test battery)\n\nExclusion Criteria:\n\n* Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.\n* Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.\n* Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and\u002For nicotine dependence).\n* Women aged 40 or over who have not had a normal mammogram in the last 24 months\n* Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill (excluding IUD or Hormone Implants).\n* Pregnant (HCG will be measured at screening)\n* Breastfeeding\n* Planned changes to psychotropic medication or psychotherapy regimen.","FEMALE","65 Years",{"count":112,"type":21},160,[114],"PHASE4","To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.",[30,117,28],"Schizophreniform Disorders","2026-06-01",{"date":93,"type":38},{"date":121,"type":38},"2019-10-07",{"date":123,"type":21},"2026-12-31",{"name":125,"class":45},"The Alfred",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":46},"100639022","exploring-the-feasibility-of-transcranial-ultrasound-stimulation-in-the-treatment-of-schizophrenia-100639022","NCT07621549","Exploring the Feasibility of Transcranial Ultrasound Stimulation in the Treatment of Schizophrenia","Inclusion Criteria:\n\n1. Age: 18-65 years old.\n2. Gender: Both males and females are eligible.\n3. Diagnosed with schizophrenia according to DSM-V criteria (a PANSS total score of less than approximately 90).\n4. No changes in medication (same dosage and same drug) for at least one month.\n\nExclusion Criteria:\n\n1. History of head injury with loss of consciousness for more than 10 minutes or a history of brain surgery.\n2. Any history of epilepsy.\n3. Presence of a family history of epilepsy\n4. Heavy alcohol consumption or use of illicit drugs (substance dependence within the last 6 months or substance abuse within the last month).\n5. Any significant medical conditions that could affect normal brain function (including but not limited to stroke, CNS infections or tumors, or other major neurological diseases).\n6. Presence of a cardiac pacemaker, implanted medication pump, intracardiac lines, or acute\u002Funstable cardiac disease, as well as intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metallic objects in or near the head (excluding oral metal objects)\n7. Pregnant or breastfeeding women.\n8. Presence of suicidal or self-harming tendencies\n9. Current use of medications known to lower the seizure threshold or increase the risk of suicidal behavior\n10. Presence of severe and uncontrolled systemic diseases (e.g., heart failure, liver failure, renal failure, vitamin B12 deficiency, hypothyroidism), as determined by the investigator to be unsuitable for study participation\n11. Patients with uncontrolled diabetic retinopathy accompanied by active fundus hemorrhage\n12. Concurrent participation in other clinical studies or clinical trials\n13. Presence of contraindications to the medical devices used in this study (including pulsed ultrasound, EEG, and CT), such as unheindividuals with obvious head trauma, unhealed head surgery, or significant physical or psychiatric symptoms.\n14. Any other conditions deemed unsuitable for participation in the clinical trial as assessed by the physician.",{"count":133,"type":21},80,[24],"1. The purpose of this study is to evaluate the safety and feasibility of transcranial ultrasound stimulation (TUS) treatment in patients with schizophrenia. Subjects are individuals diagnosed with schizophrenia who will receive non-invasive, low-intensity pulsed ultrasound stimulation targeting the hippocampus and its surrounding regions. Evaluations will be conducted before and after the treatment sessions, including electrocardiograms (ECG), blood biochemistry tests, psychiatric symptom assessments, depression level assessments, and cognitive function assessments.\n2. The primary objective is to assess the safety of this intervention in patients with schizophrenia. The secondary objective is to explore whether the current stimulation parameters may lead to improvements in the assessed symptoms. Ultimately, this study aims to support the future application of low-intensity pulsed ultrasound as a potential intervention to alleviate symptoms of schizophrenia and improve patients' quality of daily life.",[28],[138,139,140],"scizophrenia","TUS","LIPUS","2026-05-27",{"date":143,"type":38},"2026-06-02",{"date":145,"type":38},"2025-06-01",{"date":42,"type":21},{"name":148,"class":45},"Far Eastern Memorial Hospital",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":46},"100640777","phase-4-clinical-trial-of-an-il-23-inhibitor-for-immune-activation-in-clinical-trial-of-an-il-23-inhibitor-for-immune-activation-in-people-with-schizophrenia-100640777","NCT07615075","Clinical Trial of an IL-23 Inhibitor for Immune Activation in Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia","Randomized Double-Blind Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia","Inclusion Criteria: Screening\n\n* Age range of 18-64\n* Schizophrenia Group: Meet meet DSM 5 criteria for schizophrenia or schizoaffective disorder\n* Healthy Control Group: Does NOT meet DSM 5 criteria for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder.\n\nExclusion Criteria: Screening\n\n* Known current active infection, or taking an immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV\u002FAIDs associated drugs), or the scheduled use of anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin \\> 81 mg on a daily basis will be excluded.\n* Score of less than 10\u002F12 on the ESC\n\nInclusion Criteria: Clinical Trial\n\n* Age range of 18-64\n* Meet meet DSM 5 criteria for schizophrenia or schizoaffective disorder\n* Personal and Social Performance (PSP) Scale score of ≤70.\n* Treated with the same antipsychotic for at least 30 days and having received a constant therapeutic dose for at least 15 days prior to study entry\n* One test in the past of elevated AGA IgG antibodies (AGA IgG \\> 15)\n\nExclusion Criteria: Clinical Trial\n\n* Current infection, including HIV, and Hepatitis C (blood draw) or tuberculosis (TB\\*); or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol.\n* Currently taking immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV\u002FAIDs associated drugs); or the scheduled use of anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin \\> 81 mg on a daily basis will be excluded. The use of PRN anti-inflammatory agents will be allowed\n* Score of less than 10\u002F12 on the ESC",true,"64 Years",{"count":159,"type":21},40,[114],"This 16 week clinical trial investigates a precision-medicine approach to schizophrenia by targeting a biologically distinct subgroup,-approximately one-third of patients-characterized by the presence of anti-gliadin antibodies (AGA IgG+) which is associated with elevated inflammation in the IL-23\u002FIL-17 immune axis (Th17 pathway). This specific biotype is associated with pronounced negative symptoms, cognitive deficits, and reduced white matter integrity. Building on evidence that this pathway can be modulated to improve clinical outcomes, we are conducting a randomized, double-blind clinical trial of mirikizumab, an FDA-approved monoclonal antibody targeting IL-23, in addition to current antipsychotics, in schizophrenia patients who are positive for AGA IgG.\n\nThe primary objective is to determine whether mirikizumab - a repurposed FDA approved monoclonal antibody treatment inhibiting IL-23-- will be superior to placebo in treating experiential (e.g., anhedonia and asociality) negative symptoms and cognitive impairments. Secondary aims will be to assess changes in T-cell subtypes and relative abundance by gene expression, peripheral cytokines, and neuroimaging markers (in a smaller subset). By focusing on this patient subgroup, who are identified by their immune status, the research aims to provide a targeted, revolutionary treatment for symptoms that have traditionally remained resistant to standard antipsychotic therapies.\n\nThis protocol includes a screening phase, with a separate consent form which is intended to identify those with AGA IgG antibodies. This screening portion will also serve to compare other aspects of immune functioning and the TH17 pathway between patient groups and controls in order to further characterize and show that Th17 (and similar immune cell lines) are different between AGA IgG positive, AGA IgG negative and healthy controls of either status.",[30,28,163],"Healthy","2026-05-22",{"date":166,"type":38},"2026-05-29",{"date":168,"type":21},"2026-09-01",{"date":170,"type":21},"2030-09-01",{"name":172,"class":45},"University of Maryland, Baltimore",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":46},"100529464","phase-4-metabolic-effects-of-adjunctive-lumateperone-treatment-in-clozapine-treated-patients-with-schizophrenia-100529464","NCT06174116","Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia","Inclusion Criteria:\n\n* Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)\n* On clozapine treatment for at least 6 months\n* Stable dose of antipsychotic treatment for at least 1 month\n* Well established compliance with outpatient medications\n* Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.\n\nExclusion Criteria:\n\n* Psychiatrically unstable per clinical judgement by the principal investigator\n* Patients not on stable dose of antipsychotic medications\n* Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine\n* Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases\n* History of a seizure disorder\n* Pregnancy or breastfeeding\n* On lumateperone treatment in the past 3 months\n* On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)",{"count":85,"type":21},[114],"The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.\n\nParticipants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).",[30,28],[184],"Clozapine","2026-05-20",{"date":164,"type":38},{"date":188,"type":38},"2024-04-02",{"date":190,"type":21},"2027-03",{"name":192,"class":45},"University of Massachusetts, Worcester",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":46},"100593476","reach-study-recovery-environments-assessing-cognitive--brain-health-in-community-mental-health-100593476","NCT07006935","REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)","Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions","Inclusion Criteria:\n\n* (1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review\n* (2) between the ages of 18-50\n* (3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month\n* (4) able to read and speak fluent English at a sixth grade level or higher for purposes of informed consent and cognitive testing\n* For Clubhouse members, they must be a first-time, newly enrolled member\n\nExclusion Criteria:\n\n* (1) had previous membership at a Clubhouse (Magnolia or elsewhere)\n* (2) have a current severe substance use disorder\n* (3) have persistent suicidal or homicidal behavior\n* (4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)\n* (5) had recent psychiatric instability requiring hospitalization in the past month;\n* (6) history of a traumatic brain injury (TBI; based on record review)\n* (7) contraindicators for MRI (e.g., pacemaker, claustrophobia)\n* Participants in the usual care will be excluded if they are a current Clubhouse member or join a Clubhouse during participation in this research","50 Years",{"count":202,"type":21},30,[24],"The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.",[30,28,117],[207,208,209,210],"Clubhouse Model of Psychosocial Rehabilitation","Community mental health interventions","Cognition","Brain functioning","2026-04-24",{"date":213,"type":38},"2026-04-27",{"date":118,"type":21},{"date":216,"type":21},"2028-01-30",{"name":218,"class":45},"Case Western Reserve University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":46},"100514025","examining-the-efficacy-of-a-virtual-reality-cognitive-remediation-program-for-people-living-with-psychosis-100514025","NCT05973110","Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis","Inclusion Criteria:\n\n* Diagnosis of a psychosis-spectrum disorder\n* Equal or between 18 to 60 years old\n* Ability to read and speak English\n* Be clinically stable, as defined as a total Positive And Negative Severity Symptoms score equal or between 30 - 95\n* No changes to their medication dosage, starting a new medication, or stopping a medication within the past month before signing the consent form\n\nExclusion Criteria:\n\n* Neurological or medical disorders that may produce cognitive impairment (including head injury with more than 1 minute of loss of consciousness)\n* Intellectual disability or a score equal or below 70 on the Wechsler Abbreviated Scale of Intelligence.\n* Any vision conditions that cannot be corrected with contact lenses or glasses that can fit in the virtual reality googles.\n* Past history of seizures, fit, and epilepsy\n* Any severe medical condition related to the eyes, ears, and balance\n* History of substance use disorder within the last 3 months",{"count":226,"type":21},52,[24],"Individuals living with a psychotic disorder often experience changes to their thinking and social skills that can lead to challenges with work, school, relationships and living independently. One intervention to target these areas is cognitive remediation therapy, which can be delivered in virtual reality to help apply the skills and strategies learned to day-to-day life. Over the past few years, our team has co-developed a cognitive remediation program in virtual reality with healthcare professionals and people with lived experiences of psychosis. The current trial tests the feasibility and efficacy of this cognitive remediation program in virtual reality at improving thinking skills, social skills, and daily life functioning.",[230,30,28],"Psychotic Disorders",[230,232,233,234,235,236],"Cognitive Remediation","Virtual Reality","Neurocognition","Social Cognition","Community Functioning","2026-04-13",{"date":239,"type":38},"2026-04-16",{"date":241,"type":38},"2023-07-31",{"date":243,"type":21},"2026-12",{"name":245,"class":45},"The Royal Ottawa Mental Health Centre",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":274},"100441227","phase-1-determining-efficacy-and-safety-of-bxcl501-in-agitation-associated-with-pediatric-schizophrenia-and-bipolar-disorder-100441227","NCT05025605","Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","Inclusion Criteria:\n\n1. Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).\n2. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).\n3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.\n4. Participants who agree to use a medically acceptable and effective birth control method\n\nExclusion Criteria:\n\n1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.\n2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.\n3. Patients who are judged to be at significant risk of suicide.\n4. Patients with serious or unstable medical illnesses.\n5. Patients who have received an investigational drug within 30 days prior to the current agitation episode.\n6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.","10 Years","17 Years",{"count":256,"type":21},140,[258],"PHASE1","This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.",[30,261,262,263,264],"Schizo-Affective Disorder","Schizophreniform; Schizophrenic","Bipolar Disorder I","Bipolar Disorder II","2026-04-07",{"date":237,"type":38},{"date":268,"type":38},"2021-08-27",{"date":270,"type":21},"2027-12-31",{"name":272,"class":273},"BioXcel Therapeutics Inc","INDUSTRY",5,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100430646","phase-1-acetazolamide-for-treatment-resistant-schizophrenia-100430646","NCT04887792","Acetazolamide for Treatment Resistant Schizophrenia","A Randomized Controlled Trial of Acetazolamide for Patients With Treatment Resistant Schizophrenia","APTS","Inclusion Criteria:\n\n* Written informed consent.\n* Both genders, ages 18-55 years (older patients may not tolerate high ACZ dose).\n* PANSS total score \\> 60 and Score \\> 4 on one or more items of the 'positive' syndrome items (P1-P7), following treatment at therapeutic doses for 6 weeks with different APDs on 2 occasions.\n* Stable dose of antipsychotic drug (APD) for \\> 1 month, continued throughout the study.\n* Not participating in another randomized controlled clinical trial (RCT).\n\nExclusion Criteria:\n\n* Substance abuse in the past month\u002Fdependence past 6 months with the exception of methadone prescribed for opiate withdrawal.\n* History or current medical\u002Fneurological illnesses that may lead to unstable course, e.g., epilepsy.\n* Pregnancy.\n* Acetazolamide (ACZ) contraindications: hypersensitivity to ACZ; history of renal hyperchloremic acidosis; Addison's disease\u002Fadrenal failure; chronic closed angle-closure glaucoma.\n* Current or prior treatment with ACZ or history of hypersensitivity to ACZ.\n* Intellectual disability as defined in DSM 5.",{"count":284,"type":21},60,[258,58],"This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.",[30,28],[30,28,289],"acetazolamide","2026-04-06",{"date":265,"type":38},{"date":293,"type":38},"2022-02-01",{"date":295,"type":21},"2026-12-30",{"name":297,"class":45},"Vishwajit Nimgaonkar, MD PhD",2,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":46},"100346694","phase-1-cromoglicate-adjunctive-therapy-for-outpatients-with-schizophrenia-100346694","NCT03794076","Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia","Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia","CATOS","Inclusion Criteria:\n\n* Written informed consent.\n* Both genders, ages 18-60 years\n* Schizophrenia \u002F schizoaffective disorder (DSM V).\n* Treated with the same APD for at least 60 days; Stable dose of APD for \\> 1 month, continued throughout the study.\n* PANSS total score of 60 and Score 4 or more on one or more items of the 'positive' syndrome items (P1-P7)\n* Preference for patients with duration of psychosis less than 7 years.\n\nExclusion Criteria:\n\n* No illicit substance use in last 30 days\u002Fno dependence in 6 months with the exception of methadone treatment for opioid withdrawal.\n* History or current medical \u002Fneurological illnesses that may lead to an unstable course with the exception of epilepsy which is well-controlled on an antiepileptic medication for at least 6 months.\n* Pregnancy.\n* History of immune disorders, HIV infection, or receiving immune-suppressants or immuno-modulators, e.g., steroids.\n* Current or prior treatment with CGY or History of hypersensitivity to CGY.\n* Intellectual disability as defined in DSM V.",{"count":112,"type":21},[258,58],"This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.",[30,28],[63,312,313],"schizoaffective disorder","cromoglicate","2026-03-16",{"date":316,"type":38},"2026-03-19",{"date":318,"type":38},"2019-04-01",{"date":320,"type":21},"2028-06",{"name":297,"class":45},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":46},"100629033","non-invasive-brain-stimulation-using-tdcs-of-the-third-of-many-visual-pathways-100629033","NCT07469384","Non-invasive Brain Stimulation Using Tdcs of the Third (of Many) Visual Pathways","Sensory Contributions to Third Visual Pathway Dysfunction in Schizophrenia: Correlation and Causation","ButtomVP","Inclusion Criteria:\n\n1. Male or female subject, age 18-55\n2. Competent and willing to sign informed consent\n3. No more than moderately ill\n4. SCID DSM-5 diagnosis of Sz\u002FSzAff\n5. WAIS IQ \\>70\n6. Does not meet current criteria for DSM-5 defined substance abuse or dependence or have a history of diagnosis within past 6 months\n7. On medication within clinically approved range\n8. Does not meet criteria for another DSM-5 disorder other than those judged to be minor (e.g. simple phobia)\n\nExclusion Criteria:\n\n1. Significant neurological illness or history of significant head trauma\n2. Unstable physical illness or significant auditory\u002Fvisual deficits that might interfer\n3. Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)\n4. Contraindications to tDCS including metal implant, pacemaker, history of seizure, traumatic brain injury or stroke\n5. Significant risk for suicide\n6. Has a history of an illness, disease, condition injury, or disability which, in the opinion of the principal investigator, may interfere with the completion of all study requirements per protocol, impact the quality of the data, or the validity of the study results, including unstable physical illness, significant neurological illness, significant head trauma\n7. Moderate or greater DSM-5 current substance use disorder, defined based on the presence of 4 or more of 11 substance use criteria within the past 12 months. In addition, individuals for whom substance use leads to not being able to perform work, home or school activities",{"count":331,"type":21},120,[24],"This study investigates the ability of transcranial direct current stimulation (tDCS) applied over the motion processing area of the brain (area MT) to improve face emotion recognition (FER) ability. tDCS is a type of non-invasive brain stimulation in which low level currents are applied over the scalp to influence underlying brain function. In schizophrenia, impaired ability to detect facial motion has been shown to contribute to impaired FER, which, in turn, leads to difficulties in social cognition and poor social outcome. The study will use both fMRI and EEG to measure brain function while participants view moving dot and dynamic face stimuli. Analyses will compare changes in fMRI and EEG activity in individuals receiving active vs. sham stimulation.",[335,28],"SCHIZOPHRENIA 1 (Disorder)",[337,338,339,340,341,342],"social cognition","fMRI","event-related potentials","motion detection","face emotion recognition","transcranial direct current stimulation","2026-03-10",{"date":345,"type":38},"2026-03-13",{"date":347,"type":38},"2026-02-01",{"date":349,"type":21},"2030-07",{"name":351,"class":45},"Nathan Kline Institute for Psychiatric Research",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":46},"100609352","phase-4-individualized-pharmacological-approach-to-obesity-in-patients-with-bipolar-disorder-100609352","NCT07213466","Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder","Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo","OBOE-Mayo","Inclusion Criteria:\n\n* Men or women between 18 to 65 years old.\n* Patients with a SCID IV confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type (SZA-BD).\n* Women with a negative pregnancy test 48 hours before study entry (obesity phenotyping visit).\n* Patients with a negative urine drug screen except for allowable drugs.\n* Patients with a BMI ≥ 30 kg\u002Fm2 or a BMI ≥ 27 kg\u002Fm2 plus one medical comorbidity (e.g., type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea)\n* Patients must be undergoing mood stabilizer treatment but may also receive concurrent antidepressant or anxiolytic therapy.\n* Patients must be on a stable regimen of a mood stabilizer, with no changes to the medication, for at least one month prior to study enrollment.\n* Continuation of mood-stabilizing treatment is preferred but not required; the decision should be made in collaboration with the participant's primary mental health provider.\n\nExclusion Criteria:\n\n* Abdominal bariatric surgery: Gastric bypass surgery (Roux-en-Y), Adjustable gastric band (Lap band), and Gastric sleeve surgery (Sleeve gastrectomy).\n* Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, such as diabetic gastroparesis; or use of medications that may alter gastrointestinal motility and appetite.\n* Positive history of chronic gastrointestinal diseases that could affect gastrointestinal absorption such as inflammatory bowel disease (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), etc; or use of medications that may alter gastrointestinal absorption.\n* Significant untreated psychiatric dysfunction.\n* Hypersensitivity to any of the study medications.\n* Contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Oral naltrexone extended-release\u002Fbupropion extended-release (NBSR; Contrave®, Mysimba™); and Semaglutide (Weygovy™).\n* Inability to provide informed consent: participants who are on involuntary commitment, conservatorship or under a legal guardian.\n* Patients with active hypomania or mania (YMRS ≥ 20 points)\n* Patients with active psychosis (YMRS item 8 ≥ 6 points)\n* Patients with active suicide ideation (MADRS item 10 ≥ 4 points)\n* Patients with any medication changes (mood stabilizers) without advisement of study clinicians or clinical provider.\n* Patients with active bulimia (purging) or anorexia (severe restriction)\n* Patients with a history of bulimia (purging behaviors) or anorexia (severe dietary restriction) within the 12 months preceding study enrollment will be excluded\n* Current drug and\u002For alcohol use disorders (except nicotine)\n* Patients with a positive toxicology screening (except cannabis)\n* Positive toxicology screen for cannabis and a cannabis use disorder by CUDIT-R.\n* Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.\n* Patients unwilling to complete the full phenotyping day on its current form (i.e. patients avoiding gluten meal or adhering to a vegan diet).",{"count":361,"type":21},100,[114],"The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are:\n\n* Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)?\n* Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder?\n\nParticipation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone\u002FBupropion (Contrave®), or Phentermine\u002FTopiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.",[365,366,28,367,368,369],"Bipolar I Disorder","Bipolar II Disorder","Obesity","Weight Loss","GLP - 1","2026-03-06",{"date":372,"type":38},"2026-03-11",{"date":374,"type":38},"2026-01-19",{"date":376,"type":21},"2029-02-01",{"name":378,"class":45},"Mayo Clinic",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":46},"100465659","using-transcranial-magnetic-stimulation-tms-to-understand-hallucinations-in-schizophrenia-100465659","NCT05343598","Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia","Empirical Validation of a Cerebellar-cortical Hallucination Circuit","Inclusion Criteria:\n\n* Diagnosis of schizophrenia or schizoaffective disorder\n\nExclusion Criteria:\n\n* substance use disorder in past 3 months\n* ambidexterity\n* contraindications for TMS or MRI including :\n* history of neurological disorder\n* history of head trauma resulting in loss of consciousness\n* history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy\n* metal in brain or skull\n* implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt\n* claustrophobic in MRI",{"count":387,"type":21},68,[24],"This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.\n\nTMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.",[30,28],"2026-01-21",{"date":393,"type":38},"2026-01-22",{"date":395,"type":38},"2021-10-13",{"date":397,"type":21},"2026-10-31",{"name":399,"class":45},"Mclean Hospital",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":156,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":46},"100586173","visual-perception-in-schizophrenia-100586173","NCT06911931","Visual Perception in Schizophrenia","Visual Perception in Schizophrenia: Assessing Predictive Processing in the Earliest Stages of the Visual Cortical Hierarchy","Inclusion Criteria:\n\n* All Subjects\n* Aged 18-65\n* 20\u002F32 visual acuity or better (using in-house optical correction, if necessary)\n* An ability to speak English well enough to complete study assessments and to consent to the study\n* Subjects with Schizophrenia-Spectrum Disorder\n* Meets DSM-5 diagnostic criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder as confirmed by the Structured Interview for DSM-5 (SCID-5).\n* Subjects with Bipolar Disorder\n* Meets DSM-5 diagnostic criteria for bipolar disorder (type I, II, or unspecified) as confirmed by the Structured Interview for DSM-5 (SCID-5).\n\nExclusion Criteria:\n\n* All subjects\n* Presence of characteristics that could impair one's ability to comprehend the nature of the study, provide informed consent, or understand the assessment questions, including the following:\n\n  * Subject cannot read and understand the instructions well enough to complete the tasks or cannot provide informed consent.\n  * Intellectual impairment (WRAT-5 score \\\u003C 70) (at the discretion of experimenter);\n  * Actively intoxicated, as shown via patient self-report or staff report;\n  * Substance use disorder in the past 3 months;\n  * Subject considered high risk for suicidal acts (i.e., active suicidal ideation as determined by clinical interview OR any suicide attempt in 30 days prior to screening);\n  * Subject violence (involving severe\u002Flethal means or violence occurring in prior 6 months) or extreme agitation.\n  * Being in a current manic state\n  * Head injury with loss of consciousness greater than 10 minutes (at the discretion of the experimenter).\n  * Subject has had electroconvulsive therapy (ECT) in the past 8 weeks;\n  * Diagnosed with a neurological condition (tumor, stroke, brain injury) or neurological disorder, including seizure disorders. Diagnosed with pervasive developmental disorder (phone screen or medical records)\n  * Lazy eye or squint or other known ocular pathology\n* Healthy Control Subjects\n* Any lifetime psychotic disorder or history of psychiatric hospitalization (self disclosure);\n* Daily antidepressant, mood stabilizer or antipsychotic medication use in the last 6 months, or benzodiazepine use during the prior 2 days (self-disclosure); iii. First-degree relative(s) with a schizophrenia spectrum disorder (based on subject self-report) or bipolar disorder.\n* Case-match Control Non-ill Subjects\n* Any lifetime psychotic disorder (as assessed by SCID\u002For SSD);\n* Recurrent depressive episodes or being in a current depressive episode (as assessed by SCID\u002For SSD)\n* Persistent threshold psychotic symptoms\n* History of psychiatric hospitalization;\n* Daily antidepressant, mood stabilizer or antipsychotic medication use in the last 6 months, or benzodiazepine use during the prior 2 days\n* First-degree relative(s) with a schizophrenia spectrum disorder (based on subject self-report) or bipolar disorder.\n* Bipolar Subjects\n* Persistent threshold psychotic symptoms",{"count":408,"type":21},84,[24],"This study aims to identify novel markers of psychosis using electroencephalography (EEG).",[27,412,28],"Bipolar Disorder","2025-11-10",{"date":415,"type":38},"2025-11-12",{"date":417,"type":38},"2025-11-03",{"date":419,"type":21},"2027-01-31",{"name":421,"class":45},"University of Rochester",{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":434,"conditions":435,"keywords":438,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":46},"100556739","phase-2-low-amplitude-pulse-seizure-therapy-versus-standard-ultra-brief-right-unilateral-electroconvulsive-therapy-100556739","NCT06529029","Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy","Efficacy of Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy in Remission of Suicidal Ideation","LAP-ST vs ECT","Inclusion Criteria:\n\n1. Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.\n2. Male or female patients 18 to 90 years of age\n3. Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders\n4. Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item\n5. Use of effective method of birth control for women of child-bearing capacity\n6. Patient is medically stable\n7. No anticipated need to alter psychotropic medications for the duration of the study (except for urgent\u002Femergent situations)\n8. Ability of patient to fully participate in the informed consent process\n\nExclusion Criteria:\n\n1. Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment\n2. Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding\n3. History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment\n4. Implanted devices that make ECT unsafe\n5. Clinical presentation of delirium or dementia\n6. Active substance use disorders within 1 week of randomization\n7. ECT in the past 1 month or prior failure to respond to an adequate course of ECT as deemed by the ECT physician treating the patient or the PI","90 Years",{"count":202,"type":21},[58,433],"PHASE3","This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive\u002Fmemory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.",[436,437,28,412],"Suicidal Ideation","Major Depressive Disorder",[436,439,440,437,28,412,441,442,443,444],"Suicide","Depression","Low Amplitude Seizure Therapy","Electroconvulsive Therapy","Neuromodulation","Brain Stimulation","2025-09-10",{"date":447,"type":38},"2025-09-16",{"date":449,"type":38},"2024-07-03",{"date":451,"type":21},"2026-11-01",{"name":453,"class":45},"Michigan State University",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":46},"100525171","itbs-to-enhance-social-cognition-in-people-with-psychosis-100525171","NCT06118268","iTBS to Enhance Social Cognition in People With Psychosis","iSCIP","Inclusion Criteria:\n\n1. Age 18-39 years.\n2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).\n3. Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychotics permitted).\n4. Able to participate in the informed consent process and provide voluntary informed consent.\n\nExclusion Criteria:\n\n1. A history of a DSM-5 substance use disorder (other than cannabis, caffeine, or tobacco) within the past six months; or a positive baseline urine drug screen. Only participants meeting for moderate to severe cannabis use disorder will be excluded.\n2. Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset \\\u003C 35 years of age and\u002For diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)\n3. Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol\n4. Neurological disease associated with extrapyramidal signs and symptoms (e.g., Parkinson's disease); epilepsy, if the person has had one or more grand mal seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder\n5. Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg\u002Fday or higher due to the potential of these medications to limit the efficacy of iTBS\n6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history\n7. Prior Psychosurgery\n8. Presence of MRI contraindications (e.g., pacemakers)\n9. Pregnancy\n10. TMS treatment in the past three months","39 Years",{"count":361,"type":21},[24],"The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are:\n\n* Compare changes in social cognitive performance between the active vs. sham treatment groups\n* Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups\n\nEach participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.",[30,28,117,466],"Psychosis Nos\u002FOther",[468,469],"TMS","iTBS","2025-05-19",{"date":472,"type":38},"2025-05-22",{"date":474,"type":38},"2023-04-18",{"date":476,"type":21},"2027-04",{"name":478,"class":45},"Northwell Health",{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":46},"100394296","cognitive-training-for-emotion-regulation-in-psychotic-disorders-100394296","NCT04414215","Cognitive Training for Emotion Regulation in Psychotic Disorders","Inclusion Criteria:\n\n* diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder\n* 18-60 years old\n* speaks English\n* premorbid intelligence quotient \\> 70\n* clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.\n\nExclusion Criteria:\n\n* history of intellectual disability or neurological disorder\n* history of traumatic brain injury with loss of consciousness \\> 10 minutes or behavioral sequelae\n* substance use disorder within the last 6 months (other than nicotine)\n* 4\\) endorsement of MRI exclusion factors",{"count":486,"type":21},70,[24],"The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.",[30,28],"2025-02-04",{"date":492,"type":38},"2025-02-05",{"date":494,"type":38},"2020-06-01",{"date":496,"type":21},"2029-12-31",{"name":498,"class":45},"University of Georgia",{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":524},"100511886","critical-time-intervention-peer-support-100511886","NCT05945277","Critical Time Intervention-Peer Support","Effectiveness of the Critical Time Intervention-Peer Support (CTI-PS) Model for Persons With Serious Mental Illness Discharged From Inpatient Psychiatric Treatment Facilities in Portugal","CTI-PS","Inclusion Criteria:\n\n* 18-65 years of age.\n* Any psychotic disorder diagnosis based on the International Classification of Diseases - 10th revision (ICD-10) criteria, including both non-affective (e.g., schizophrenia) and affective psychosis (e.g., bipolar disorder)\n* Having been discharged from inpatient psychiatric treatment facilities in the month prior to recruitment\n\nExclusion Criteria:\n\n* Active suicidal ideation.\n* Cognitive, neurological, or other sensorial conditions likely to preclude or affect an objective assessment via interview procedures",{"count":284,"type":21},[24],"There is increasing awareness of the importance of providing mental health services and support that promote a recovery-oriented and human rights-based approach. A mental health service system that is guided by a rehabilitation and recovery perspective places emphasis on treating the consequences of the illness rather than just the illness \"per se\", and on empowering people to regain control of their identity and life, and to have hope for the future. Within this philosophy, mental health policies in several countries advocate for the introduction of peer workers in mental health services, people with lived experience of mental health issues and recovery, who are employed to use their lived experience to support those who access mental health services. However, more effectiveness and implementation research is needed. Evidence also suggests that the period following hospital discharge is of high risk of treatment dropout for people with serious mental illness, thus interrupting their recovery process. Therefore, this vulnerable population may particularly benefit from more targeted interventions during this transitional period.\n\nThe research project will conduct a pilot randomized controlled trial to evaluate the feasibility, implementation and potential effectiveness of the Critical Time Intervention-Peer Support model, a recovery-oriented based model for people with serious mental illness discharged from inpatient psychiatric treatment facilities in Portugal. The randomized controlled trial (RCT) will be conducted in three psychiatric services in the Lisbon Metropolitan Area and their catchment areas. People with diagnoses of psychotic disorders discharged from inpatient psychiatric treatment facilities will be recruited and randomly divided into CTI-PS intervention or usual care. Those allocated to the intervention group will additionally receive CTI-PS rather than usual care alone over a 9-month period. Outcomes at baseline, 9- and 18-months will be analyzed by multilevel models, considering the observations clustered within sites. Longitudinal analyses will be used to examine trends over time of the outcomes of interest.\n\nThe implementation of the CTI-PS model will introduce a novel approach to community mental health care that has not yet been tried in Portugal. This study aims to explore to what extent this intervention can be effectively implemented in countries with the characteristics of Portugal. Additionally, the proposed research aims to contribute to the global knowledge about peer interventions by exploring whether the CTI model can maintain its effectiveness using peers.",[230,30,412,28],[512,513,514],"Recovery","Peer support","Severe mental illness","2024-06-28",{"date":517,"type":38},"2024-07-01",{"date":519,"type":38},"2023-07-01",{"date":521,"type":21},"2025-12-31",{"name":523,"class":45},"Lisbon Institute of Global Mental Health - LIGMH",3,"Schizo-affective Disorder"]