[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizoaffecitve-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizoaffecitve-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100626349","a-virtual-reality-mindfulness-application-for-aggression-in-schizophrenia-100626349",false,"NCT07434479","A Virtual Reality Mindfulness Application for Aggression in Schizophrenia","Inclusion Criteria:\n\nTRIPP MBI VR and TAU Distraction Groups have the same inclusion criteria. Participants will:\n\n1. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.\n2. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.\n3. Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment.\n4. Demonstrate documented evidence of good medication adherence for the 2 weeks prior to enrollment, as determined by electronic medication records review and prescriber reported adherence to prescribed schedule as documented in the participant's medical records.\n5. Have a history of impulsive aggression as assessed by a score of ≥ 4 on any item on Impulsive Aggression Factor (IA) on the Impulsive- Premeditated Aggression Scale (IPAS; Stanford et al., 2003).\n6. Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR\n7. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia or schizoaffective disorder, as defined in the SCID-5-RV at the Screening Visit.\n8. Adult or late adolescent, between 18 and 64 years of age at the time of informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n1. Have past head trauma\n2. Diagnosed with a neurological disorder\n3. Are pregnant or breastfeeding women as evidenced by the participant's medical record.\n4. Have unstable medical illness that compromises the safety of the patient\n5. Have significant suicidal ideation at screening (as assessed by the Columbia - Suicide Severity Rating Scale (C-SSRS; participant answers \"Yes\" to \"suicidal ideation\" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS; Non-suicidal self-injurious behavior is not exclusionary)\n6. Are on Electroconvulsive therapy (ECT) within 6 months of the study, participants with metal in their bodies or who have claustrophobia or who do not pass the criteria in NKI's Magnetic Resonance Safety Questionnaire (MRSQ)\n7. Score \\\u003C 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003)\n8. Have a violent episode requiring seclusion, restraints, or a prn within the week before screening\n9. Evidence of suboptimal medication adherence in the 2 weeks prior to enrollment, as determined by electronic medication records review, and demonstrated by prescriber reported non- adherence to prescribed schedule. Suboptimal adherence includes missed doses (two of more missed doses within the past 2 weeks) or plasma levels indicating that the participant is not receiving the intended therapeutic dose.","ALL","18 Years","64 Years",{"count":19,"type":20},58,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study investigates whether a virtual reality-based mindfulness based intervention can reduce impulsive aggression in individuals with schizophrenia or schizoaffective disorder. The primary goal is to evaluate whether mindfulness delivered via VR (MBI-VR) improves emotion regulation and engages the dorsomedial prefrontal cortex (dmPFC), a brain region involved in cognitive control and regulation of emotional responses. The study also examines whether these effects show a dose-related relationship.\n\nParticipants will be randomized to receive different doses of MBI-VR intervention or distraction tasks and will complete repeated mindfulness VR sessions. Brain activity will be measured using functional magnetic resonance imaging (fMRI) during an emotion regulation task, along with clinical assessments of impulsive aggression related symptoms.",[26,27,28],"Schizophrenia Disorder","Schizoaffecitve Disorder","Aggression",[30,31,32,33,34],"mindfulness based intervention","schizophrenia","dmPFC","emotion regulation","impulsive aggression","RECRUITING","2026-06-09",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":20},"2026-06-05",{"date":43,"type":20},"2027-12-31",{"name":45,"class":46},"Manhattan Psychiatric Center","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100639781","phase-2-confirmatory-trial-of-gamma-neurofeedback-to-improve-working-memory-in-schizophrenia-100639781","NCT07592169","Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia","Confirmatory Efficacy Trial to Confirm the Effects of Gamma EEG-Neurofeedback on Working Memory in Schizophrenia","Inclusion Criteria:\n\n* 1\\. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) 2. Age 18-55 years 3. Clinically stable: no psychiatric hospitalization in the 3 months prior to enrollment 4. No change in antipsychotic medication type or dosage within 4 weeks prior to baseline assessment 5. Ascertained to be clinically and medically stable by a study investigator 6. Does not meet DSM-5 diagnostic criteria for bipolar disorder or current major depressive episode 7. No electroconvulsive therapy (ECT) within 6 months of baseline assessment 8. Able to read and speak English (corrected vision or hearing aids acceptable) 9. Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* 1\\. Self-reported history of seizure disorder 2. Diagnosed with multiple sclerosis 3. History of stroke or major vascular disease, including insulin-dependent diabetes mellitus 4. HIV\u002FAIDS diagnosis 5. Current (not past) major depressive episode 6. Substance use disorder other than nicotine use disorder or caffeine use disorder in the past year 7. Brain cancer (primary or metastatic) 8. Prior head injury involving loss of consciousness 9. Inability to read or speak English 10. Color blindness that interferes with administration of study assessments 11. Neuropsychological or cognitive testing in the past 6 months using the same measures as this study 12. Score on Letter-Number Sequencing greater than 1 standard deviation above the age-normed mean","55 Years",{"count":57,"type":20},104,[59],"PHASE2","This study is a confirmatory, double-blind, placebo-controlled randomized clinical trial (RCT) testing whether gamma EEG neurofeedback (EEG-NFB) improves working memory in adults with schizophrenia or schizoaffective disorder. Participants are randomly assigned to receive either active gamma EEG-NFB (real-time feedback of frontal gamma brain activity) or sham EEG-NFB (false pre-recorded feedback), twice weekly for 12 weeks. Working memory (N-back task), brain gamma coherence, and everyday community functioning are assessed at baseline, mid-treatment, end of treatment, and follow-up.",[62,27],"SCHIZOPHRENIA 1 (Disorder)",[31,64,65,66,67,68,69,70],"neurofeedback","EEG","gamma oscillations","working memory","randomized controlled trial","n-back","community functioning","NOT_YET_RECRUITING","2026-05-11",{"date":74,"type":39},"2026-05-18",{"date":76,"type":20},"2026-06-01",{"date":78,"type":20},"2030-05-31",{"name":80,"class":46},"University of California, San Diego",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":107},"100625508","phase-1-a-petmri-study-of-cobenfy-on-dopamine-transmission-in-schizophrenia-100625508","NCT07423546","A PET\u002FMRI Study of Cobenfy on Dopamine Transmission in Schizophrenia","A Multimodal PET\u002FMRI Study of Cobenfy on Dopamine Transmission in Schizophrenia","Inclusion Criteria:\n\n1. Individuals aged 18 to 50, inclusive at screen\n2. Capable of understanding the study procedures and able to provide informed consent\n3. Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder\n4. Antipsychotic free at Visit 1 (by choice and for reasons unrelated to the study), and for at least 3 weeks (4 for aripiprazole, Cobenfy or LAIs) at the time of the baseline PET scan, inclusive of any antipsychotic-free time prior to consent\n5. PANSS total score \\> 80 and \\\u003C 120\n6. Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only)\n7. Stable dosing of herbal\u002Fdietary supplements for at least 6 weeks at the time of the first dose of Cobenfy and willingness to avoid products with known hepatotoxic ingredients (e.g., green tea extract, kratom, ashwagandha).\n\nExclusion Criteria:\n\n1. Diagnosis of moderate or severe substance use disorder within the previous month (from first PET scan)\n2. A history of poor or inadequate response to Cobenfy for any reason, hypersensitivity to Cobenfy or trospium or no justifiable reason to expect improvement on Cobenfy, or treatment with Cobenfy within 4 weeks of the first PET Scan\n3. EKG abnormality that is clinically significant including a QT interval \\> 450 msec for men and \\> 470 msec for women, as corrected by the Fridericia formula (QTcF)\n4. Pregnant or breast-feeding women. Women of child-bearing potential must have a negative serum β-hCG pregnancy test at Visit 1, must have been using an acceptable method of contraception (section 5.3) for 30 days before the study, and must agree to do so for the whole study and 30 days after (unless post-menopausal or surgically sterile)\n5. Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety on study medication, including (but not necessarily limited to) the following: urinary retention, moderate or severe hepatic impairment, gastric retention, untreated narrow-angle glaucoma, hypernasality, resting heart rate \\>100 bpm or systolic Blood Pressure \\>150 mmHg, a history of orthostatic hypotension or abnormal orthostatic blood pressure (change in mean arterial pressure \\[1\u002F3 systolic + 2\u002F3 diastolic\\] of \\> 20% between supine and standing blood pressures), known human immunodeficiency virus (i.e., by history), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, symptomatic gallstone disease, active hepatic infections, history of bladder stones, recurrent urinary tract infections, or International Prostate Symptom Score \\> 7 or any one item \\> 2 (not including the nocturia item).\n6. Any material in the body that is a contraindication for MRI procedures or participated in prior nuclear medicine procedures in the past year that exceed FDA-defined limits when combined with radiation dosimetry from PET scanning in this protocol to avoid exceeding annual dosimetry limits (metal screener repeated before MRI scan during visit 2)\n7. Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the past 1 month or suicidal behavior in the past 3 months\n8. Laboratory abnormality that would compromise the well-being of the participant, including Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\> 2 times the upper limit of the laboratory normal reference range, elevated bilirubin (i.e., \\>2 x upper limit of normal (ULN)), or serum prostate specific antigen (PSA) \\>10 ng\u002Fml (for men only).\n9. A history of treatment resistance to antipsychotics\n10. Use of nicotine products within the previous month (prior to first PET scan)\n11. History of significant violent behavior when antipsychotic-free or currently homicidal\n12. Positive toxicology screen for any substances of abuse","50 Years",{"count":90,"type":20},12,[92,59],"PHASE1","This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \\[18F\\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission.\n\nThe overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission\u002Fsynthesis capacity in the striatum and midbrain as measured by \\[18F\\]DOPA Kicer (\\[18F\\]DOPA relative uptake rate)).",[62,27],[96,97,98],"Cobenfy","PET","MRI","2026-04-06",{"date":101,"type":39},"2026-04-13",{"date":103,"type":20},"2026-07-01",{"date":43,"type":20},{"name":106,"class":46},"New York State Psychiatric Institute",1]