[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychosis":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,73,0,25,[9,46,79,111,143,186,219,247,277,302,323,355,394,417,445,467,503,524,548,567,595,626,650,673,696],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100600144","mentalization-based-treatment-mbt-in-help-seeking-youths-with-a-clinical-high-risk-condition-for-psychosis-chr-p-100600144",false,"NCT07093671","Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)","Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial","MBT-Psychosis","Inclusion Criteria:\n\n* Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria\n* Patients who provide informed consent\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of a psychotic disorder\n* Intellectual disability (IQ \\\u003C 70).\n* Patients whose psychotic symptoms are primarily induced by substance misuse.\n* Patients with significant language barriers\n* Parents\u002Flegal authority who do not provide informed consent (only minors)\n* Adult patient under guardianship\n\nNote: Comorbidities with other psychiatric disorders (e.g., Autism Spectrum Disorder, Personality Disorders) will not constitute an exclusion criterion.","ALL","14 Years","30 Years",{"count":22,"type":23},212,"ESTIMATED","INTERVENTIONAL",[26],"NA","The primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Specifically, the investigator will assess diagnostic outcomes using a 3-level variable: transition to psychosis, CHR-P status quo, and remission out of CHR-P, as well as CHR-P symptom expression. The investigator hypothesize that: (1a) the experimental treatment (MBT + NBCI) will have a significant effect on diagnostic status (i.e. transition to psychosis) at the end of treatment and follow-up; (1b) the experimental treatment (MBT + NBCI) will significantly reduce the severity of psychotic symptoms at the end of treatment and follow-up.",[29],"Psychosis",[29,31,32],"MBT","Mentalization-Based Treatment","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2025-08-01",{"date":41,"type":23},"2028-08-31",{"name":43,"class":44},"Marco Armando","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100588940","phase-3-a-study-to-evaluate-safety-and-efficacy-of-karxt--karx-ec-as-a-treatment-for-psychosis-associated-with-alzheimers-disease-adept-5-100588940","NCT06947941","A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)","A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n* Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).\n* Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.\n* Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.\n* Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).\n\nExclusion Criteria:\n\n* Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.\n* Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.\n* Participants must not have certain safety concerns, including certain laboratory test irregularities.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years","90 Years",{"count":56,"type":23},325,[58],"PHASE3","The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.",[61,29],"Alzheimer Disease",[63,64,65,66,29,67,68],"Alzheimer disease","Alzheimer's disease","Alzheimer's","Dementia","Alzheimer's disease psychosis","Alzheimer's disease psychosis with or without agitation",{"date":70,"type":37},"2026-06-30",{"date":72,"type":37},"2026-03-25",{"date":74,"type":23},"2028-03-20",{"name":76,"class":77},"Bristol-Myers Squibb","INDUSTRY",22,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":45},"100605036","online-intervention-to-improve-motivation-100605036","NCT07157293","Online Intervention To Improve Motivation","An Online Intervention To Enhance Motivation and Goal-Directed Behavior","Online Mot","Inclusion Criteria:\n\n* Diagnosis of schizophrenia or a related psychotic disorder\n* Meeting criteria for being at clinical high risk for psychosis\n\nExclusion Criteria:\n\n* Does not have access to a computer each week","18 Years","65 Years",{"count":90,"type":23},60,[26],"Participants will complete one online intervention lasting 12 weeks. Each week, they will be asked to complete a 20-30 minute session online. The intervention is targeting improved mood and positive affect in order to support increases in motivation and goal-directed behavior. Before and after the intervention, participants will be asked to complete measures to assess symptoms, mood, and behavior.",[94,95,29],"Schizophrenia Prodromal","SCHIZOPHRENIA 1 (Disorder)",[97,98,99,100],"negative symptoms","schizophrenia","psychosis","digital health","NOT_YET_RECRUITING","2026-06-23",{"date":104,"type":37},"2026-06-24",{"date":106,"type":23},"2026-08",{"date":108,"type":23},"2028-08",{"name":110,"class":44},"University of Alabama at Birmingham",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":24,"phases":121,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":45},"100631623","pilot-study-of-sensor-informed-smartphone-based-mental-health-interventions-for-mood-in-early-psychosis-100631623","NCT07503093","Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis","Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis","Inclusion Criteria:\n\n* Age 18-50 years\n* History of DSM-5 psychotic disorder (e.g., schizophrenia, schizoaffective disorder, psychosis not otherwise specified)\n* Current elevated mood symptoms, defined as mild or greater depressive symptoms (Patient Health Questionnaire-8 score ≥5) or anxiety symptoms (Generalized Anxiety Disorder-7 score ≥5)\n* Own a personal iPhone or Android smartphone\n* Willing and able to provide informed consent\n* English-speaking\n\nExclusion Criteria:\n\n* Active suicidal ideation with both intent and a specific plan.\n* Current substance use disorder requiring acute treatment\n* Diagnosis of neurodevelopmental disorder that would impair ability to use smartphone app or complete study procedures\n* Traumatic brain injury with significant cognitive impairment","50 Years",{"count":120,"type":23},10,[26],"The aim of this trial is to evaluate the feasibility and preliminary efficacy of using passive smartphone sensors to detect moments of heightened negative mood and inform the timing of brief mental health interventions, such as mindfulness exercises and psychoeducation, in adults with early psychosis.",[29,124,125,126],"Anxiety","Depression","Rumination",[128,129,29,130,131,132,133],"Mirco-Randomized Study","Mobile Health","Digital Mental Health","Negative Mood","Digital Phenotyping","Passive Sensors","2026-06-22",{"date":136,"type":37},"2026-06-25",{"date":138,"type":23},"2026-08-01",{"date":140,"type":23},"2027-06-01",{"name":142,"class":44},"Mclean Hospital",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":155,"briefSummary":156,"conditions":157,"keywords":164,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100642980","feel-good-a-multicenter-trial-of-a-mindfulness-based-group-therapy-in-young-adults-with-early-psychosis-100642980","NCT07645443","FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis","Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)","FEEL-GOOD","Inclusion Criteria:\n\n* Age 16 to 35 years\n* Clinical diagnosis of early psychosis, defined as first psychotic episode within the last 5 years as assessed with the Structural Clinical Interview for DSM-5 Research Version (SCID-5-RV)\n* DSM-5 schizophrenia spectrum or other psychotic disorder confirmed with SCID-5-RV (DSM-5: 297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) Currently receiving inpatient\u002Fday clinic treatment with a planned stay of at least 4 weeks\n* Interested in and willing to participate in FEEL-GOOD and\u002For TAU.\n\nExclusion Criteria:\n\n* Insufficient German language abilities\n* Acute suicidality or acute threat to others","16 Years","35 Years",{"count":154,"type":23},252,[26],"FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone. The intervention consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. Outcomes are assessed at baseline, 4 weeks post-intervention, and 6 months follow-up, with the primary outcome being observer-rated total psychopathology as measured with the assessed by the total score of the Positive and Negative Syndrome Scale (PANSS) post-treatment (4 weeks post baseline).",[158,159,160,161,29,162,163],"Early Onset Psychosis","First Psychotic Episode Within the Last 5 Years","First-episode Psychosis","Schizophrenia Spectrum Disorders (SSD)","Psychosis NOS","Randomized Controlled Trial (RCT)",[165,166,167,168,169,170,171,172,173,29,174,175],"Randomized controlled trial","Emotion regulation","Ecological momentary assessment","Early psychosis","First-episode psychosis","Mindfulness-based intervention","PANSS","EMA","Schizophrenia spectrum disorder","Mindfulness","observer-rated","2026-06-09",{"date":178,"type":37},"2026-06-12",{"date":180,"type":37},"2026-05-27",{"date":182,"type":23},"2028-12-31",{"name":184,"class":44},"Stephanie Mehl",8,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":193,"maxAge":20,"enrollmentInfo":194,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100326055","semantic-and-syntactic-computerized-analysis-of-free-speech-100326055","NCT03525054","Semantic and Syntactic Computerized Analysis of Free Speech","ASESID","Inclusion Criteria:\n\n* Major and\u002For minor from 15 to 30 years old\n* Who alleged a suicidal gesture or idea or behavior that has repercussions in their emotional, social or professional life\n* If patients receive neuroleptic treatment that impairs cognitive abilities, a one-week wash-out period will be scheduled prior to assessment.\n* Affiliated with or beneficiary of a health insurance\u002Fsocial security system\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* History of psychosis\n* Risk of self-harm or violence not compatible with outpatient treatment\n* QI\\\u003C70 (WAIS)\n* Neurological disorder or major health problem\n* Impossibility to interrupt neuroleptic treatment for one week\n* Refusal to participate","15 Years",{"count":195,"type":23},215,"OBSERVATIONAL","Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques",[199,29,200,94,201],"Psychotic Disorders","Schizophrenia and Related Disorders","Diagnosis, Psychiatric",[199,201,94,203,204,205,206,207,208],"Ultra High Risk","Prediction Of Psychosis","Machine Learning","Automated Language Analysis","Semantic Coherence","Syntaxic Complexity","2026-05-29",{"date":211,"type":37},"2026-06-02",{"date":213,"type":37},"2018-05-18",{"date":215,"type":23},"2030-05-02",{"name":217,"class":44},"University Hospital, Brest",3,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":24,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":45},"100638199","developing-a-virtual-reality-assisted-intervention-for-emotion-regulation-difficulties-in-psychosis-100638199","NCT07623928","Developing a Virtual Reality-assisted Intervention for Emotion Regulation Difficulties in Psychosis","MANaging emOtions in Everyday Life Using Virtual REality (MANOEUVRE): Developing a VR-assisted Intervention for Emotion Regulation Difficulties in Psychosis","MANOEUVRE","Inclusion Criteria:\n\n* Currently under the care of South London and Maudsley (SLaM) National Health Service (NHS) outpatient services.\n* Clinical diagnosis of psychosis (schizophrenia spectrum disorder) (as assessed by their clinical team)\n* Willing to have the interview audio recorded (if taking part in post therapy interview)\n* Willing and able to provide informed consent to participate in the study (as assessed by their clinical team)\n\nExclusion Criteria:\n\n* Clinical presentation (e.g., immediate serious risk to self) (as assessed by their clinical team)\n* History of photosensitive epilepsy",{"count":228,"type":23},15,[26],"Supporting people with psychosis to manage their emotions using virtual reality\n\nMany people who have experienced psychosis feel overwhelmed by their emotions. Emotions get in the way of doing what matters to them. They want support to manage emotions differently. There is evidence that people with psychosis find talking therapies that teach skills for managing emotions helpful. People said it helped them to understand and manage their emotions. However, they also wanted more help to apply skills they learned to their lives.\n\nIt is hard to help people to use therapy skills in real-life situations. Therapists cannot be present when the skills are needed. One solution is to use virtual reality (VR) to bridge the gap between the clinic and real-life. VR involves using a headset to see and hear a very life-like computer-generated simulation of everyday life situations. People with psychosis find VR therapies engaging and helpful. It can feel safer to try things out in VR.\n\nGuided by the feedback of people with psychosis, this research will evaluate a novel therapy to help people with psychosis manage their emotions. Face-to- face therapy will be combined with VR so that people can practice emotion regulation skills safely with \"live\" coaching from a therapist. This should support people to use these skills when they need them.\n\nFifteen people with psychosis will be offered the therapy. Everyone will be asked what they think of it and complete questionnaires before and after therapy to see what impact it had on their lives.\n\nA lived experience advisory group will support all aspects of the research process.",[29,95,200],[166,29,233,234,235,236,237],"Virtual reality","Schizophrenia spectrum disorders","Virtual reality exposure therapy","Psychotherapy","Dialectical behaviour therapy","2026-05-28",{"date":240,"type":37},"2026-06-03",{"date":242,"type":23},"2027-09-01",{"date":244,"type":23},"2028-11-01",{"name":246,"class":44},"King's College London",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":152,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":256,"briefSummary":257,"conditions":258,"keywords":266,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100613164","phase-3-cognitive-strategies-in-early-psychosis-2-100613164","NCT07263022","Cognitive Strategies in Early Psychosis 2","COSTEP 2","Inclusion Criteria:\n\n* Between the ages of 18 and 35\n* Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment\n* Estimated IQ of 70 or above\n* Proficient at English as determined through interactions with the study team\n* No change in psychiatric medication within a week of enrollment or MRI study visits\n* No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI\u002FCo-Is\n\n  * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days.\n  * Participants are to have no changes to medications in the past 7 days before drug administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).\n\nExclusion Criteria:\n\nMedical Criteria:\n\n* Presence of the following medical concerns as determined by the study PI:\n\n  * Major neurological disorder\n  * History of a clinically significant head injury with or without prolonged unconsciousness\n  * Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating\n* History of any of the following as reported by the participant:\n\n  * Renal impairment, injury, or disease\n  * Hepatic impairment, injury, or disease\n  * Myocardial infarction or heart disease, or endorsement of history of or of cardiac symptoms at intake:\n\n    * Dyspnea\n    * Palpitations\n    * Orthopnea\n    * Pedal oedema\n    * Significant dizziness\n    * Syncope\n    * Claudication\n  * Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis\n* Presence of unmanaged hypertension (\\>140\u002F90) or elevated resting heart rate (\\>100 bpm)\n* Abnormal clinical laboratory values:\n\n  * uACR \\> 30 mg\u002Fg\n  * creatinine level \\>0.95 mg\u002FdL\n  * AST or ALT \\> 50 U\u002FL\n  * Bilirubin \\> 1.2 mg\u002FdL\n  * Total Protein \\\u003C 6 g\u002FdL\n* Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)\n* Allergies to study drugs\n* Is pregnant, planning to become pregnant, or is breastfeeding\n* Cannot pass the visual acuity test\n* Cannot pass the CMRR Subject Safety Screen due to MRI contraindications\n\nMental health criteria:\n\n* Meets criteria for a severe substance or alcohol use disorder within 3 months of enrollment\n* Lifetime history of a stimulant use disorder\n* Current manic episode as determined by the MINI\n* History of psychiatric hospitalization within 3 months of enrollment\n* Meets criteria for clinical risk of suicidal behavior, as defined by:\n\n  * Clinician judgment\n  * A suicide attempt within 3 months of enrollment\n  * Active suicidal ideation at screening or baseline, as indicated by the C-SSRS Screener\n  * Previous intent to act on suicidal ideation with a specific plan and\u002For preparatory acts within 3 months of enrollment, as indicated by the C-SSRS Screener\n* Symptom severity scores in the severe (6) or extremely severe (7) range on the BPRS for the following items: suicidality, disorientation, bizarre behavior, excitement, elevated mood\n* Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating\n\nOther criteria:\n\n* Unable or unwilling to provide informed consent\n* Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study\n* Current guardianship\n* Is under civil commitment or under a stay of civil commitment\n* Illiteracy\n* Has engaged in significant cognitive training, in the opinion of the PI, in the last year",{"count":255,"type":23},24,[58],"The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are:\n\n* Does a single dose of modafinil change how people with psychosis play the brain games?\n* Does a single dose of d-serine change how people with psychosis play the brain games?\n* Does a single dose of modafinil change brain activity?\n* Does a single dose of d-serine change brain activity?\n\nParticipants will:\n\n* Complete an interview and self-report questionnaires.\n* Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.\n* Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart.\n* Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.\n* Play brain games on a computer that measure decision making, thinking, and problem solving skills",[29,259,260,261,262,162,263,264,265],"Schizophrenia Disorder","Schizoaffective Disorder","Major Depressive Disorder With Psychotic Features","Bipolar Disorder With Psychotic Features","Schizophreniform Disorder","Psychotic Disorder","Cognition",[265,267,268,269],"Decision Making","fMRI","Psychosis spectrum disorders",{"date":209,"type":37},{"date":272,"type":23},"2026-07-07",{"date":274,"type":23},"2030-04-30",{"name":276,"class":44},"University of Minnesota",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":283,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":284,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":292,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":45},"100608046","precision-brain-stimulation-to-reduce-cannabis-craving-in-schizophrenia-100608046","NCT07196462","Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia","Inclusion Criteria for Psychosis Participants:\n\n* Age between 18-65 years\n* Diagnosis of a psychotic disorder according to DSM-5 criteria and confirmed by SCID\n* Current cannabis use of at least 2\u002F10 on a Visual Analog Scale\n* Current cannabis use (confirmed by urine cannabis testing)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient psychiatric treatment and psychiatrically stable with no recent (within the past 30 days) psychiatric hospitalizations or changes in their psychiatric medication regimens.\n\nInclusion Criteria for Healthy Controls:\n\n\\- All of the above except for participants will not have a diagnosis of a psychotic disorder nor a first-degree relative with a psychotic disorder.\n\nExclusion Criteria for ALL participants:\n\n* DSM-5 intellectual disability\n* Substance use disorder (other than cannabis or nicotine) within the past three months\n* Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)\n* Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions\n* History of head trauma resulting in any loss of consciousness (\\>15 minutes) or neurological sequelae\n* Current history of poorly controlled headaches including chronic medication for migraine prevention\n* History of fainting spells of unknown or undetermined etiology that might constitute seizures\n* History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n* Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)\n* Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD\n* All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study\n* Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of CNS active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.\n* Any changes in medications or hospitalizations within the past 30 days.\n* Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit\n\nThese exclusion criteria strictly follow all recommended guidelines as endorsed by the International Federation of Clinical Neurophysiology and the International Society for Transcranial Stimulation.",true,{"count":285,"type":23},100,[26],"The central hypothesis is this: Brain circuits most relevant to cannabis use in schizophrenia are distinct from pathways identified in healthy controls who use cannabis. This study seeks to provide evidence that targeted stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cue-induced craving and cognitive performance in individuals with schizophrenia and schizoaffective disorder, while targeted stimulation of the L DLPFC leads to these changes in healthy controls who use cannabis. This study will test a model that integrates brain network pathophysiology and cognition to 1) explain the prevalence of cannabis use in schizophrenia and 2) identify a target for engagement in schizophrenia. This study seeks to establish a neuroscientific framework to guide future treatment-oriented studies aimed at reducing craving and improving cognitive performance in individuals with schizophrenia and schizoaffective disorder.\n\nThis is a study of the effect of 2 rTMS interventions on functional connectivity and craving in individuals with schizophrenia or schizoaffective disorder and healthy controls who use cannabis.\n\nAim 1: Target Engagement: Determine if rTMS manipulates functional connectivity of each target (DMN, L DLPFC) (n=100).\n\nAim 2: Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=100).\n\nAs an exploratory analysis, the factors that explain individual variance in rTMS-induced connectivity change will also be explored.",[289,290,29,291],"Cannabis Use","SCHIZOPHRENIA","rTMS",[293,98,291,294],"cannabis use","brain stimulation",{"date":211,"type":37},{"date":297,"type":37},"2026-01-15",{"date":299,"type":23},"2027-12-31",{"name":301,"class":44},"Vanderbilt University Medical Center",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":283,"sex":18,"minAge":87,"maxAge":53,"enrollmentInfo":308,"targetDuration":4,"studyType":24,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":45},"100434706","neurobehavioral-mechanisms-of-social-isolation-and-loneliness-in-serious-mental-illness-100434706","NCT04940663","Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness","Inclusion Criteria:\n\n1. 18-55 years old\n2. Experienced a psychotic disorder or mood disorder\n\nExclusion Criteria:\n\n1. Any neurological disorder or current substance use disorder (during the past 6 months)\n2. Not proficient in English\n3. A recent change in medication, or an acute symptom presentation\n4. Standard exclusion criteria for participation in an MRI scan (e.g., presence of metal in the body, claustrophobia, a history of head trauma).",{"count":309,"type":23},120,[26],"The proposed research will test the hypothesis that objective social isolation and loneliness are linked to neurobehavioral mechanisms involved in social perception and motivation in individuals with and without serious mental illness. Moreover, it will investigate the specific dynamic interactions among these experiences in daily life and how they, and their neurobehavioral predictors, are linked to day-to-day functioning. The findings of this project could provide novel targets for therapeutics aimed at improving functioning and overall quality of life in individuals with serious mental illnesses, as well as quantitative phenotypes for use in early detection efforts.",[29,313],"Schizophrenia","2026-05-07",{"date":316,"type":37},"2026-05-11",{"date":318,"type":37},"2022-07-13",{"date":320,"type":23},"2026-06",{"name":322,"class":44},"Massachusetts General Hospital",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":283,"sex":18,"minAge":87,"maxAge":53,"enrollmentInfo":331,"targetDuration":4,"studyType":24,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":45},"100608043","early-psychosis-investigating-cognition-100608043","NCT07196423","Early Psychosis: Investigating Cognition","Glutamate Changes as a New Neurocognitive Marker in Psychosis","EPIC","Inclusion Criteria for FEP Group (studies 1a and 1b):\n\nEligibility criteria for first episode psychosis group are as follows:\n\n1. Aged 18-55 years.\n2. Ability to understand and willing to give written informed consent.\n3. Fluent in English to be able to understand all cognitive task instructions and questionnaires.\n4. Current psychotic disorder of less than 5yrs total duration. Defined as meeting DSM-5 criteria consistent with a diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, or severe depression with psychosis.\n5. At least 8 weeks of stable treatment.\n6. Ability to travel to the University of Nottingham for in-person testing.\n\nExclusion Criteria for FEP Group (Studies 1a and 1b):\n\n1. Clinically significant neurological or comorbid psychiatric disorder in the opinion of the investigator.\n2. History of clinically significant head injury\n3. Current harmful use of, or dependence on, psychoactive substances (excluding nicotine) in the opinion of the investigator\n4. Current use of any medication which may interfere with the study in the opinion of the investigator, i.e. any medication that might affect the neurochemicals of interest\n5. Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy, metal implants, etc.)\n6. Contraindications for transcranial direct current stimulation as assessed by standard screening form (e.g. cardiac pacemaker or other implanted devices, seizures, epilepsy, open head wound, etc.)\n7. Having taken part within the previous month as a participant in a clinical trial that involved taking a drug or having an invasive procedure.\n\nInclusion Criteria for Healthy Matched Controls (Studies 1a and 1b):\n\nMatched healthy control participants will be recruited from a local database of volunteers, from posters and online advertisements.\n\nInclusion criteria (matched controls):\n\n1. Aged 18 - 55 years.\n2. Ability to understand and willing to give written informed consent.\n3. English as first language or fluent in English.\n4. Ability to travel to the University of Nottingham for in-person testing.\n\nExclusion criteria for Health Matched Controls (Studies 1a and 1b):\n\n1. Personal or family history of psychosis.\n2. Clinically significant neurological or psychiatric disorder.\n3. History of clinically significant head injury.\n4. Current harmful use of, or dependence on, psychoactive substances (excluding nicotine and caffeine) in the opinion of the investigator.\n5. Current use of any medication, which may interfere with the study in the opinion of the investigator i.e. any medication that might affect the neurochemicals of interest.\n6. Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy etc).\n7. Contraindications for transcranial direct current stimulation as assessed by standard screening form (e.g. cardiac pacemaker or other implanted devices, seizures, epilepsy, open head wound, etc.)\n8. Having taken part within the previous month as a participant in a clinical trial that involved taking a drug, being paid an inconvenience allowance, or having an invasive procedure (e.g. venepuncture \\>50ml, endoscopy).\n\nInclusion Criteria for participants with lived experiences of psychosis (Study 2):\n\n1. Aged 18+ years.\n2. Ability to understand and willing to give written informed consent.\n3. Fluent in English to be able to understand and answer all questions.\n4. History of psychotic disorder defined as DSM-5 criteria for diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, or severe depression with psychosis. No limit of time since first episode.\n5. At least 8 weeks of stable treatment.\n6. Ability to travel to the University of Nottingham for in-person testing.\n\nExclusion Criteria for participants with lived experiences of psychosis (Study 2):\n\n1. Clinically significant neurological or comorbid psychiatric disorder.\n2. Current harmful use of, or dependence on, psychoactive substances (excluding nicotine) in the opinion of the investigator.\n3. Having taken part within the previous month as a participant in a clinical trial that involved taking a drug or having an invasive procedure.\n4. Lived experience where psychosis symptoms have not been directly experienced by the individual (e.g., support or carer role to someone else).",{"count":332,"type":23},106,[26],"The project aims to explore changes in brain chemistry in individuals who have recently experienced psychosis. Recent research suggests that chemicals in the brain, specifically one called glutamate, may behave differently in people who have experienced psychosis compared to those who have not. It is also known that some individuals with psychosis can find tasks involving memory and attention more challenging. This study aims at understanding how brain chemistry is linked to memory and attention, and if this is different between people who have and have not experienced psychosis.\n\nThe study will also investigate how a commonly used brain stimulation technique might help people with psychosis and other conditions by altering brain chemistry for a very short period. Non-invasive brain stimulation using very weak electrical stimulation has been used to help improve symptoms in individuals with psychosis and many other conditions, and has been shown to alter brain chemistry for a few hours after stimulation. However, it does not work for everyone. It will be investigated if levels of glutamate can predict whether brain stimulation will help an individual or not. In other words, the study investigates if glutamate can be used as a marker for tailoring treatments.\n\nThis project also aims to collect personal experiences or challenges that individuals with psychosis face. This information will be gathered through interviews. This will help to understand what specific difficulties individuals have, such as with certain aspects of memory and attention. The interview will also gather opinions and concerns about brain imaging and brain stimulation and current understandings of chemicals in the brain. For example, the study will explore why individuals may not want to take part in brain imaging or brain stimulation.",[336,29],"First Episode Psychosis (FEP)",[99,338,339,340,341,342,343,344,345],"cognition","glutamate","transcranial direct current stimulation","fMRS","first episode psychosis","GABA","working memory","magnetic resonance spectroscopy","2026-04-28",{"date":348,"type":37},"2026-05-04",{"date":350,"type":37},"2026-02-09",{"date":352,"type":23},"2027-08",{"name":354,"class":44},"University of Nottingham",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":363,"minAge":364,"maxAge":53,"enrollmentInfo":365,"targetDuration":4,"studyType":24,"phases":367,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":45},"100460949","phase-4-examining-the-effects-of-estradiol-on-neural-and-molecular-response-to-reward-100460949","NCT05282277","Examining the Effects of Estradiol on Neural and Molecular Response to Reward","Examining the Effects of Estradiol on Neural and Molecular Response to Rewards in Perimenopausal-Onset Anhedonia and Psychosis","PEEPS","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study\n* 44-55 years old unmedicated perimenopausal women who have ≥ 2 skipped menstrual cycles, amenorrhea ≥ 60 days, corresponding to the late menopause transition (Stages of Reproductive Aging Workshop (STRAW stage -1).\n* Anhedonia or psychosis symptoms that began during the period of menstrual irregularity.\n* Clinician's Global Impression Scale-Severity score (CGI-S) \\> 3 to confirm a clinically impaired sample.\n* Anhedonia severity inclusion criteria and stratification: All participants will have Snaith-Hamilton Pleasure Scale (SHAPS) scores \\> 20 consistent with the NIMH Fast-Fail Trial for Mood and Anxiety Disorders, corresponding to clinically impairing anhedonia.\n* Psychosis severity inclusion criteria and stratification: Participants will be stratified according to scores on the psychotic subscale of the Brief Psychiatric Rating Scale (BPRS)\n* Willingness to adhere to the estradiol regimen\n\nExclusion Criteria:\n\n* Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®.\n* BMI \\\u003C 18 or \\> 35 kg\u002Fm\\^2\n* A history of chronic menstrual cycle irregularity, meaning \\> 1 year without menses\n* MR contraindications: Metal in the body, dental work other than fillings or gold, tattoos, metal injury, any other implant unless they are 100% plastic.\n* PET contradictions: participation in \\>1 research study in the past 12 months that included ionizing radiation exceeding 3 rem to the whole body (e.g., PET, CT). Standard of care imaging is not exclusionary.\n* The use of psychotropics or hormonal preparations.\n* History of psychiatric illness during the 2 years before the onset of perimenopause.\n* History of chronic, recurrent mood or psychotic disorders (i.e., more than one non-reproductive-related mood episode prior to the perimenopausal index episode).\n* A history of mood episodes requiring hospitalization.\n* Current mania;\n* Depressive episode(s) within 2 years of enrollment not associated with the transition to menopause;\n* A history of suicide attempts within the last year or current active suicidal ideation with intent and plan.\n* Neurological conditions (e.g., history of seizure or TBI)\n* Brain stimulation treatment in the past six months.\n* Endometriosis;\n* First degree relative with premenopausal breast cancer or breast cancer presenting in both breasts or multiple family members (greater than three relatives) with postmenopausal breast cancer.\n* Current medication use (i.e., current psychotropics, current anti-hypertensives, current statins, current hormonal preparations, or frequent use of anti-inflammatory agents (\\> 10 times\u002Fmonth)). Women will be allowed to enroll who take medications without known mood effects (e.g. stable thyroid hormone replacement and occasional (\\\u003C 5 times\u002Fmonth) use of Ambien)\\*;\n* Pregnant, breastfeeding or trying to conceive;\n* Last menstrual period more than 12 months prior to enrollment;\n* History of undiagnosed vaginal bleeding;\n* Undiagnosed enlargement of the ovaries;\n* Polycystic ovary syndrome;\n* History of breast or ovarian cancer;\n* First degree relative with ovarian cancer;\n* Abnormal finding in a provider breast exam and\u002For mammogram;\n* Known carrier of BRCA1 or 2 mutation;\n* Porphyria;\n* Malignant melanoma;\n* Hodgkin's disease;\n* Recurrent migraine headaches that are preceded by aura;\n* Gallbladder or pancreatic disease\\*\\*;\n* Heart or kidney disease\\*\\*;\n* Liver disease;\n* cerebrovascular disease (stroke);\n* First degree relative with history of heart attack or stroke;\n* Current nicotine use;\n* Self-reported claustrophobia\n* Peanut allergy\n\n  * all reported prescription medications will be reviewed and cleared by a study physician prior to a participant's enrollment;\n\n    * participants will be given the opportunity to describe these conditions in the online screening survey. Reported conditions that are acute in nature and\u002For benign will be reviewed by a study physician and exclusions will be decided case-by-case. All chronic conditions will be exclusionary. For those where it is deemed that an exclusion does not apply, primary analyses will not be affected, but exploratory analyses will be conducted excluding these individuals","FEMALE","45 Years",{"count":366,"type":23},103,[368],"PHASE4","This proposal will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis symptoms as well as on brain function using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR).",[125,29,371],"Anhedonia",[373,371,374,375,376,377,378,379,380,381,382,383,384,385],"Reproductive Affective Disorder","Perimenopause","Estrogen","Hormone Replacement Therapy","Mood Disorders","Estradiol Treatment","Sex Steroids","Psychosis Symptoms","Depressive Disorders","Estradiol","Hormones","Reward Activation","Reproductive Control Agents",{"date":387,"type":37},"2026-04-29",{"date":389,"type":37},"2022-04-20",{"date":391,"type":23},"2026-12-31",{"name":393,"class":44},"University of North Carolina, Chapel Hill",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":193,"maxAge":20,"enrollmentInfo":402,"targetDuration":4,"studyType":24,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100500449","phase-3-efficiency-of-a-composite-personalised-care-on-functional-outcome-in-early-psychosis-100500449","NCT05796401","Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis","PsyCARE Trial - \"Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial \"","PSYCARE","Inclusion Criteria:\n\n* Adolescent and young adults, both sexes, aged 15 to 30 years,\n* Persons characterised according to the CAARMS criteria \\[8\\] as UHR or FEP in the first year after having received diagnosis and care, if any\n* Informed and written signed consent,\n* Participant with regular health insurance\n\nExclusion Criteria:\n\n* Severe and unstabilised medical conditions,\n* Insufficient level in reading and\u002For French language,\n* Current participation in another intervention trial or in a full cognitive remediation programme,\n* Enforced hospitalization ,\n* Intellectual Deficiency (i.e. Intelligence Quotient\\\u003C70), and \u002F or sensorimotor deficits incompatible with the cognitive reinforcement,\n* Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the inclusion criteria),\n* Current severe depression (in case of doubt, MADRS \\> 34),\n* Receiving therapeutic levels of antipsychotics for more than 12 months,\n* Current medication with benzodiazepine \\>30 mg per day equivalent diazepam\n* Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 5 cannabis cigarettes AND\u002FOR severe substance use disorder (DSMV criteria\u002Fdependence DSMIV criteria) other than nicotine during the last 6 months or for more than 5 years.\n* Pregnant women, parturients, and lactating women,\n* Individuals deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L3212-1 and 3213-1 (Public Health Code),\n* Individuals of legal age who are the subject of a legal protection measure or unable to express their consent",{"count":403,"type":23},500,[58],"Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery.\n\nPioneering epigenetic analyses indicate that psychosis onset involves oxidative stress and inflammation suggesting that neuroprotective strategies could limit or even prevent the onset of or the transition into a chronic disorder. Several biological factors associated with the emergence of psychosis can all be rectified by using safe and easily accepted supplements including alterations folate deficiency\u002Fhyperhomocysteinemia; redox imbalance and deficit in polyunsaturated fatty acids (PUFA). The prevalence of these anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy.\n\nCognitive remediation improves quality of life (QoL) and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in patients at ultra-high risk (UHR) for psychosis and patient with a first episode of psychosis (FEP) and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatising tools, such as applications with cognitive strategies, motivational tools and functioning guidance personalised according to the need of each individual. Patients can have access to it, wherever they live.\n\nEarly psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training.\n\nThe study hypothesis is that promoting neuroplasticity by cognitive training and personalised virtual psychoeducation guidance could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients UHR or FEP and that this effect is modulated by individual brain plasticity abilities. The overall objective of PsyCARE\\_trial is to improve early intervention in psychosis by providing a composite personalised care (CPC) that will enable personalised cognitive training and psychoeducation guidance, adapted to individuals' needs, cognitive abilities and biological background.",[29],"2026-04-15",{"date":409,"type":37},"2026-04-20",{"date":411,"type":37},"2023-12-15",{"date":413,"type":23},"2029-02-15",{"name":415,"class":44},"Centre Hospitalier St Anne",13,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":151,"maxAge":20,"enrollmentInfo":424,"targetDuration":4,"studyType":24,"phases":426,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100597315","effects-of-action-based-cognitive-remediation-on-substance-misuse-in-early-phase-psychosis-100597315","NCT07056894","Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis","Evaluating a Brief Virtual Cognitive Remediation Therapy Intervention for Those With Early Phase Psychosis and Substance Misuse in NS\u002FNL: Addressing Challenges in Underserviced Areas","Inclusion Criteria:\n\n* This study will enroll individuals 16-30 years of age from the Early Intervention Services for Psychosis programs in Nova Scotia and the Psychosis Intervention Early Recovery program in Newfoundland\n* Diagnosed with a primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder)\n* Less than 5 years of psychotic illness\n* Has problematic alcohol and\u002For cannabis use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT) or Cannabis Use Disorder Identification Test-Revised (CUDIT-R)).\n\nExclusion Criteria:\n\n* Current stimulant use disorder",{"count":425,"type":23},50,[26],"Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected. The age of onset for psychotic disorders often begin during the critical years of youth and early adulthood, resulting in significant challenges for individuals and their families, including difficulties with thinking, relationships, and overall well-being. They also carry significant economic costs, both for health care and lost productivity. Early intervention services have been shown to improve outcomes when provided during the first few years of illness known as early phase psychosis (EPP). However, substance use, especially alcohol and cannabis, can interfere with the effectiveness of these services. Many young people with psychosis misuse these substances, which can harm brain development, worsen symptoms, reduce medication use, and lower quality of life. Despite understanding the risks, there are few effective ways to reduce substance misuse in patients with EPP.\n\nOne promising approach to reducing substance misuse in this population is cognitive remediation therapy, which helps improve thinking skills and everyday functioning. Studies have found that some cognitive remediation therapies can help reduce alcohol use in chronic schizophrenia, but there is limited research targeting the EPP population. Our research team at the Nova Scotia Early Psychosis Program recently completed a pilot study that indicated a therapy called Cognitive Enhancement Therapy (CET) helped participants reduce their problematic alcohol and cannabis use. However, challenges with recruitment and lower attendance rates noted towards the end of the 6-month therapy course suggests that patients with EPP would benefit more from a therapy with a shorter timeframe. Alternatively, Action-Based Cognitive Remediation (ABCR) targets the same cognitive domains believed to help reduce substance use as CET, but has a shorter, more concise schedule. ABCR cover 16 sessions delivered bi-weekly for 2 months, compared to 45 sessions over 6 months of CET. ABCR has been tested in the EPP population and has shown positive results when delivered in person, hybrid and remotely. Although this therapy is demonstrating benefits for patients including improvement in daily functioning and social cognition, its effects on substance misuse have not been researched. This study aims to investigate whether treatment with ABCR helps patients with EPP reduce their alcohol and\u002For cannabis use.",[29,429,430],"Alcohol Use Disorder","Cannabis Use Disorder",[432,433,434,99],"alcohol","cannabis","action based cognitive remediation","2026-04-01",{"date":437,"type":37},"2026-04-07",{"date":439,"type":23},"2026-03-27",{"date":441,"type":23},"2028-03-31",{"name":443,"class":44},"Nova Scotia Health Authority",2,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":24,"phases":454,"briefSummary":455,"conditions":456,"keywords":457,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":444},"100593087","phase-4-cannabis-potency-effects-on-brain-white-matter-in-early-phase-psychosis-100593087","NCT07001878","Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis","Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis: A Pilot Feasibility Treatment Study","Inclusion Criteria:\n\n* This study will enroll individuals 18-25 years of age from the Nova Scotia Early Psychosis Program\n\nExclusion Criteria:\n\n* Current stimulant use disorder","25 Years",{"count":255,"type":23},[368],"Canada reports some of the highest rates of cannabis use in our youth and young adult populations, among all the developed countries. Recent Health Canada surveys report that 27% of 16-19-year-olds and 32% of 20-24-year-olds have used cannabis in the past 30 days, with 16-24-year-olds showing the highest rates of daily or near-daily use. Unfortunately, cannabis use has also been found to be a risk factor for the development of a psychotic disorder in emerging adults, and in those who develop psychosis and continue cannabis use, there is a significant effect on long term outcomes. This includes the severity of symptoms, risks of relapse (being hospitalized) and not reaching a level of functioning that would be expected. Lifetime experience with cannabis is greater than 80% in young adults with early phase psychosis (EPP; the first 5 years of a psychosis illness) with up to 30% of Canadian EPP patients meeting criteria for a diagnosis of cannabis use disorder (CUD) at entry to care. A recent Canadian population-based study found that cannabis use disorder associated to psychosis has risen from 3.7% pre-2018 to 10.3% at present. There has been a significant increase in Δ9-tetrahydrocannabinol (THC) levels in cannabis products available globally over the years, with popular cannabis products available start as high as 18% THC in Canada. However high potency cannabis carries a more significant risk for psychosis development, as well as higher risk for cannabis dependence and other severe mental health issues.\n\nA major gap in the research is a specific focus on cannabis potency on brain white matter (WM) in youth and young adults, and if there are any potential treatment strategies that could be used to influence any of these cannabis WM effects. To address this, a medication called metformin, that is already used in psychosis to help with side effects of antipsychotic medications, will be used as it has also shown promise to influence WM changes in other illnesses. This project is thus focused on naturalistic cannabis potency effects on WM in emerging adults in EPP (divided into three groups; those using high potency cannabis, low potency cannabis, and minimal cannabis use) and treating them with metformin for 6 months and assessing effects on neuroimaging, cognitive and clinical variables.\n\nThe purpose of this pilot feasibility study is to inform the development\u002Frefinement of an intervention protocol, and not to test potential effects or mechanisms as the sample size will have insufficient power to perform an in-depth analysis. The results of this work will inform our research strategy development and assess feasibility of our novel methodological approach.\n\nParticipants will:\n\n1. Visit the clinic at baseline, 3 months (only Timeline Follow-Back Assessment administered), and 6 months post baseline to complete substance use and mental health questionnaires, and cognitive assessments\n2. Complete an MRI scan at baseline and 6 months\n3. Take Metformin every day for 6 months",[29,289],[433,458,459,460],"metformin","early phase psychosis","potency",{"date":437,"type":37},{"date":463,"type":37},"2025-03-18",{"date":465,"type":23},"2026-12-01",{"name":443,"class":44},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":283,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":474,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":45},"100568934","immune-mechanisms-of-antipsychotic-treatment-response-100568934","NCT06687694","Immune Mechanisms of Antipsychotic Treatment Response","IMAT","Inclusion Criteria\n\nParticipants with psychosis symptoms:\n\n* Age 18-65\n* Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as confirmed by a psychiatrist involved in their treatment.\n* Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the treating clinical team.\n* Due to start or change to a new regular antipsychotic medication. (Participants who are initiating antipsychotic treatment for the first time, transitioning to a different antipsychotic medication, or resuming a formerly prescribed antipsychotic medication that was discontinued for a minimum of two weeks may be recruited.)\n\nControl Participants\n\n* Age 18-65\n* No active autoimmune disorder.\n* No history of psychosis symptoms.\n\nExclusion Criteria\n\nParticipants with psychosis symptoms:\n\n* Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.\n* Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).\n* Inability to have blood tests.\n\nControl participants:\n\n* Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.\n* Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).\n* Inability to have blood tests.\n\nOptional lumbar puncture only:\n\n* Significant lower spinal deformity (such as spina bifida), injury (such as stenosis) or previous lower spinal surgery.\n* Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.\n* Known or suspected clotting disorder.\n* Clinically significant abnormality in full blood count.\n* Known or suspected raised intracranial pressure, assessed by study clinician.\n* Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.\n* History of chronic or recurrent headaches, in the opinion of the investigator.",{"count":403,"type":23},"The aim of this study is to investigate the role of the immune system in psychotic symptoms and their response to treatment. The investigators will collect blood and cerebrospinal fluid samples from participants with psychosis symptoms who are about to start or change to a new regular antipsychotic treatment as well as a control group for comparison.\n\nParticipants will be assessed at two main timepoints, at visit 1 (Week 0) and at visit 2 (4 +\u002F-2 weeks). For participants with psychosis symptoms visit 1 will take place at the start or change of antipsychotic medication. The studies goal is to identify biomarkers that can aid in diagnosis, prognosis, treatment selection, and tracking treatment response.\n\nThe investigators aim to recruit participants from the following groups:\n\n1. Individuals with psychosis symptoms presenting to acute or outpatient services who are due to be started on or change to a new regular antipsychotic medication.\n2. Age- and sex-matched control participants without neuropsychiatric disease.\n\nFindings could potentially impact the treatment of psychotic illnesses by offering mechanistic insights into targeted immune-based interventions for these disorders through high-resolution immunophenotyping techniques alongside targeted immunological assays. Ultimately, the research aims to contribute valuable resources for future studies exploring the connection between immune processes and neuropsychiatric conditions.",[29],[29,478,479,480,481,313,482,483,484,485,486,487,488,489,490,491,492,493,494,495],"Antipsychotic","Neuroimmunology","Inflammation","Autoantibody","Schizotypal disorder","Persistent delusional disorders","Acute and transient psychotic disorders","Induced delusional disorder","Schizoaffective disorders","Other nonorganic psychotic disorders","Unspecified nonorganic psychosis","Manic episode","Bipolar affective disorder","Depressive episode","Recurrent depressive disorder","Persistent mood [affective] disorders","Other mood [affective] disorders","Unspecified mood [affective] disorder","2026-03-24",{"date":72,"type":37},{"date":499,"type":37},"2025-08-06",{"date":501,"type":23},"2031-07",{"name":246,"class":44},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":283,"sex":18,"minAge":151,"maxAge":53,"enrollmentInfo":510,"targetDuration":4,"studyType":24,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":45},"100518882","study-of-language-disorders-and-interactions-between-mnesic-capabilities-and-semantic-competencies-in-patients-with-psychosis-100518882","NCT06036316","Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis","TDLRipsy","Inclusion Criteria:\n\n* All Groups:\n\n  * Patient affiliated or entitled to a social security scheme\n  * Patient having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study\n  * For minor participants, at least one of the parents or holders of parental authority having been informed of the study, having received the information note relating to it and not having objected to the participation of his or her child\n  * Native language: French\n* ARMS and FEP Patient Group:\n\n  * Age between 16 and 35 years old\n  * Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment of At Risk Mental State (CAARMS) or present the criteria for Disorders of the course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A)\n* Patients with schizophrenia group:\n\n  * Age between 16 and 55 years old\n  * Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American Psychiatric Association, 2015)\n  * Present the criteria for Disorganization of Speech and Formal Thought Disorder as defined by the Thinking, Language and Communication (TLC) Rating Scale.\n* Healthy Volunteers Group:\n\n  * Age between 16 and 55 years old\n  * Parental authorization (of both parents) to participate in the study for minor patients\n\nExclusion Criteria:\n\n* All groups:\n\n  * Pregnant, parturient or nursing mother\n  * Person deprived of liberty by a judicial or administrative decision\n  * Person in a life-threatening emergency\n  * Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)\n  * Adult person unable to express their consent and who is not the subject of a legal protection measure\n  * Impairment of the subject making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them\n  * Abuse or dependence of any substance according to DSM V criteria excluding cannabis\n* Healthy Volunteers Group:\n\n  * Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI) excluding anxiety disorder\n  * Presence of developmental disorder of oral language or written language revealed on clinical examination.",{"count":511,"type":23},90,[26],"This research concerns the study of language disorders of patients present in the spectrum of psychosis. It is indeed accepted that psychotic disorders are associated with language difficulties, which are only poorly highlighted thanks to reusable tools in clinical practice. These language disorders impact communication, and concern many linguistic domains, thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems relevant to characterize these language disorders and to assess to what extent they interact with the other symptoms of the pathology, in particular the course of the thought disorder and the neuropsychological symptoms. In addition, this study is particularly interested in the interactions between working memory capacities and those related to syntax. It is intended for different patients suffering from psychotic disorders of different intensities, treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete language assessment, evaluating each domain mentioned above, on the expressive and understanding sides. The results of the language assessment will be compared with those of a control group in the same tests. They will also be analyzed with regard to the neuropsychological and psychiatric elements noted in the patient's medical file, in order to highlight possible associations between language skills, neuropsychological and psychiatric symptoms in this patient population.",[29,313,515,516],"At-risk Mental State","Language Disorders",{"date":439,"type":37},{"date":519,"type":37},"2024-01-23",{"date":521,"type":23},"2026-06-01",{"name":523,"class":44},"Centre Psychothérapique de Nancy",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":531,"targetDuration":4,"studyType":24,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":45},"100630475","improving-health-literacy-in-patients-with-schizophrenia-spectrum-disorder-100630475","NCT07488156","Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder","The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder","Inclusion Criteria:\n\n* Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient behavioral health unit ages 18 and older with a new or previous diagnosis of schizophrenia spectrum disorder outside of substance use disorders\n* Patients must be proficient in English.\n* Patients must have a government issued social security number (required for reimbursement through the university).\n\nExclusion Criteria:\n\n* Patients at UMCNO that are ages 17 or younger\n* Patients with SSD and concomitant intellectual disability, as evidenced by prior documented history on chart review or patients suspected to have intellectual disability or impairment based on clinical interactions\n* Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications\n* Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization\n* Patients that are not proficient in English\n* Patients that do not have a government issued social security number",{"count":532,"type":23},34,[26],"The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder\n\nThis interventional study is aimed at:\n\n* assessing and improving the health literacy and\n* assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.",[259,260,29],[537,313,234,538],"Educational interventions","Health literacy","2026-03-17",{"date":541,"type":37},"2026-03-23",{"date":543,"type":23},"2026-03-01",{"date":545,"type":23},"2028-01-01",{"name":547,"class":44},"Louisiana State University Health Sciences Center in New Orleans",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":53,"enrollmentInfo":554,"targetDuration":4,"studyType":24,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":444},"100524364","cerebellar-modulation-of-cognition-in-psychosis-100524364","NCT06107764","Cerebellar Modulation of Cognition in Psychosis","Inclusion Criteria:\n\n* Age between 18-55 years\n* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month\n* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:\n\n  * Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;\n  * History of fainting spells of unknown or undetermined etiology that might constitute seizures\n  * History of multiple seizures or diagnosis of epilepsy\n  * Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n  * Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n  * Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or transcutaneous electric nerve stimulation unit\n  * Ventriculo-peritoneal shunt\n  * Signs of increased intracranial pressure\n  * Intracranial lesion\n  * History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n  * Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.",{"count":555,"type":23},95,[26],"The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).\n\nParticipants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.",[313,260,559,29],"Bipolar Disorder I","2026-03-16",{"date":539,"type":37},{"date":563,"type":37},"2024-07-31",{"date":565,"type":23},"2029-12",{"name":142,"class":44},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":24,"phases":576,"briefSummary":577,"conditions":578,"keywords":581,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":594},"100629114","the-mouth-matters-in-mental-health-trial--2-100629114","NCT07470437","The Mouth Matters in Mental Health Trial -2","A Link Work Intervention to Support Dental Visiting in People With Severe Mental Health Difficulties: The Mouth Matters in Mental Health Effectiveness and Cost-Effectiveness Trial","Inclusion Criteria:\n\n* Aged ≥18 years.\n* Receipt of care from community mental health or early intervention teams at the point of referral.\n* No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. Emergency dental care (e.g. emergency attendance at an Accident \\& Emergency Appointment or a dental hospital) is not included within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.\n* Able to provide informed consent as determined by trained researchers in consultation with the clinical team.\n\nExclusion Criteria:\n\n* Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community.\n* Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and\u002For the referrer in approximately one-months' time to determine if risk has subsided to a point where they are now eligible.\n* Enrolled in another dental randomised controlled trial.",{"count":575,"type":23},480,[26],"This clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life.\n\nThe main predictions are that:\n\n1. The link work intervention plus treatment as usual will lead to greater likelihood of attendance at a routine dental appointment, compared with treatment as usual alone.\n2. The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone.\n3. The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.",[579,580,29],"Mental Health","Oral Health Care",[582,583,584],"Mouth Matters","Dentistry","mental health","2026-03-13",{"date":539,"type":37},{"date":588,"type":23},"2026-05-01",{"date":590,"type":23},"2029-07-31",{"name":592,"class":593},"Lancashire and South Cumbria NHS Foundation Trust","NETWORK",5,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":603,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":605,"conditions":606,"keywords":613,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":45},"100581888","a-novel-blood-test-as-a-biomarker-in-mental-health-100581888","NCT06856161","A Novel Blood Test as a Biomarker in Mental Health","A Novel Blood Test as a Differential Diagnosis and Drug Efficacy Biomarker in Mental Health","LEADING-MH","Inclusion Criteria:\n\nI. Age 19+. II. Informed consent by participant\n\nIII. Any of the following situations:\n\n1. Suspected, new onset or established depression.\n2. First episode of psychosis or suspected\u002Festablished schizophrenia. IV. In the opinion of the Investigator, the participant will likely be able to complete the standardized mental health questionnaires administered in each study visit.\n\nExclusion Criteria:\n\nI. Inability to provide informed consent. II. Currently enrolled in any other research study involving drugs or devices that may confound mental health treatment outcomes.\n\nIII. Currently declared on extended leave Under British Columbia's Mental Health Act.","19 Years",{"count":403,"type":23},"This longitudinal, observational study aims to assess whether the characteristics of a novel blood peripheral biomarker can serve as indicators for depression and schizophrenia in patients at the Royal Columbian Hospital Psychiatric Clinics. The study will evaluate whether changes in these biomarker characteristics can help distinguish between depressed patients who do or do not respond to treatment and between individuals experiencing a single psychotic episode and those at risk of progressing to schizophrenia. To achieve this, blood samples and standardized mental health assessments will be collected across three study visits from up to 500 participants, grouped into two study arms based on their diagnosis: Depression (DEP) or Psychosis\u002FSchizophrenia (PSY).",[607,608,29,609,610,611,612,429],"Depression - Major Depressive Disorder","Schizophenia Disorder","Mania (Neurotic)","Alcohol Consumption","Anxiety Disorder (Panic Disorder or GAD)","Substance Use Disorders",[584,614,615,98,99,616],"biomarker","depression","SERT","2026-03-03",{"date":619,"type":37},"2026-03-05",{"date":621,"type":37},"2025-03-25",{"date":623,"type":23},"2027-08-31",{"name":625,"class":44},"Fraser Health",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":634,"targetDuration":4,"studyType":24,"phases":635,"briefSummary":636,"conditions":637,"keywords":640,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":45},"100623328","acceptability-feasibility-and-preliminary-outcomes-of-the-kiso-mind-app-for-outpatients-with-schizophrenia-spectrum-disorders-100623328","NCT07395206","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial","KISO","Inclusion Criteria:\n\n* ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder\n* Age: 18 - 65 years\n* Sufficient German Language Proficiency\n* Ability to Use a Smartphone\n\nExclusion Criteria:\n\n* Intensive Psychotherapy Protocols (more than one psychotherapy session a month)\n* CGI-Score \\\u003C 3; \\> 6\n* No smartphone\n* Neurological Disorders or Brain Damage\n* Acute Suicidality\n* Acute Heavy Substance Abuse or Addiction\n* Current Electroconvulsive Therapy",{"count":90,"type":23},[26],"The Kiso pilot study is a randomized controlled trial to test the acceptability and feasibility of a novel digital intervention, namely the Kiso Mind smartphone app. A parallel-group design is utilized. Participants either receive access to the Kiso Mind intervention and treatment-as-usual (TAU) in the experimental condition or receive treatment as usual (TAU) in the control condition. The intervention is designed for participants diagnosed with either schizophrenia (F20.0) or schizoaffective disorder (F25.0) according to the ICD-10.\n\nTo examine acceptability, feasibility, and preliminary effectiveness, both self-report and rater-based assessments are administered at baseline (T0) and at the end of the 12-week intervention period (post-intervention T1). Lastly, a qualitative interview will be conducted with participants from the experimental condition. The primary outcome of the present study is the acceptability and feasibility of the Kiso Mind app. The secondary outcome consists of general psychopathology, and positive-, negative-, depressive symptoms, as well as social functioning and self-efficacy ratings.",[29,199,638,639,313,260],"Primary Psychotic Disorders","Schizophrenia Spectrum Disorders",[29,199,638,313,260,639,641,642],"Digital Intervention","E-Health","2026-02-28",{"date":617,"type":37},{"date":646,"type":37},"2026-01-30",{"date":70,"type":23},{"name":649,"class":44},"Charite University, Berlin, Germany",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":658,"enrollmentInfo":659,"targetDuration":4,"studyType":24,"phases":660,"briefSummary":661,"conditions":662,"keywords":663,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":45},"100627206","comparison-of-accelerated-intermittent-theta-burst-stimulation-vs-high-frequency-transcranial-magnetic-stimulation-hf-rtms-on-cognitivesymptoms-in-treatment-resistant-schizophrenia-100627206","NCT07445620","Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia","Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia: DB-RCT","DB RCT","Inclusion Criteria:\n\n* Diagnosed with treatment-resistant schizophrenia according to TRIIP Consensus criteria\n* Age: 18-60 years\n* Currently receiving clozapine treatment for at least 6 months\n* Attending psychiatry outpatient department at AIIMS Bhubaneswar\n\nExclusion Criteria:\n\n* Currently receiving or recently received ECT\u002FrTMS\u002FtDCS\n* Co-morbid psychiatric, major medical, or neurological disorders\n* History of withdrawal seizures, delirium tremens, or significant head injury\n* Presence of pacemaker or metal in any part of body (excluding mouth)\n* Pregnant or lactating women","60 Years",{"count":511,"type":23},[26],"This randomized, double-blind, sham-controlled trial compares three brain stimulation approaches-accelerated intermittent theta burst stimulation (aITBS), high-frequency repetitive transcranial magnetic stimulation (HF-rTMS), and sham stimulation-for treating cognitive deficits in treatment-resistant schizophrenia. Ninety patients receiving clozapine will be randomized 1:1:1 to receive 20 sessions over 4 weeks targeting the dorsolateral prefrontal cortex. The primary outcome is change in cognitive function measured by B-CATS score at 2, 4, and 12 weeks. Secondary outcomes include social cognition, symptom severity, brain metabolism (FDG-PET), and inflammatory biomarkers.",[29,259],[291,664],"Cognitive deficit","2026-02-27",{"date":617,"type":37},{"date":668,"type":23},"2026-02-15",{"date":670,"type":23},"2029-12-14",{"name":672,"class":44},"All India Institute of Medical Sciences, Bhubaneswar",{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":680,"targetDuration":4,"studyType":24,"phases":682,"briefSummary":683,"conditions":684,"keywords":687,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":594},"100521612","enhanced-coordinated-specialty-care-for-early-psychosis-100521612","NCT06071858","Enhanced Coordinated Specialty Care for Early Psychosis","Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis","Inclusion Criteria:\n\n* People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:\n* McLean Hospital OnTrack (OnTrack Clinic)\n* Massachusetts General Hospital (FEPP Clinic)\n* Boston Medical Center (WRAP Clinic)\n* Cambridge Health Alliance (RISE Clinic)\n* UMass Memorial Health Care (STEP Clinic)\n* ServiceNet (PREP West)\n\nExclusion Criteria:\n\n* None",{"count":681,"type":23},350,[26],"The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:\n\n• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?\n\nParticipants will either:\n\n* Receive care as usual (CSC) or\n* Receive care as usual (CSC) plus five additional care elements (CSC 2.0):\n\n  1. Individual peer support\n  2. Digital outreach\n  3. Care coordination\n  4. Multi-family group therapy\n  5. Cognitive remediation\n\nResearchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.",[29,313,260,685,686],"Psychosis Nos\u002FOther","Bipolar Disorder",[342,688],"early psychosis","2026-02-25",{"date":665,"type":37},{"date":692,"type":37},"2024-02-01",{"date":694,"type":23},"2028-10",{"name":142,"class":44},{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":700,"acronym":4,"eligibilityCriteria":701,"healthyVolunteers":12,"sex":18,"minAge":193,"maxAge":152,"enrollmentInfo":702,"targetDuration":4,"studyType":24,"phases":704,"briefSummary":705,"conditions":706,"keywords":707,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":712,"completionDateStruct":714,"leadSponsor":716,"locationsCount":45},"100390753","normobaric-oxygen-therapy-for-individuals-with-first-episode-psychosis-100390753","NCT04368039","Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis","* Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.\n* Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory .\n* No evidence of a pre-existing intellectual disability defined as a premorbid IQ \\>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4.\n* Ages 15-35\n* Non-smoker for past six months\n* Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale\n* The American Association for Respiratory Care notes that \"no absolute contraindications to oxygen therapy exist when indications \\[for oxygen therapy\\] are present.\"",{"count":703,"type":23},20,[26],"Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.",[29,313,160],[99,708,709],"treatment","normobaric hyperoxia","2026-02-23",{"date":689,"type":37},{"date":713,"type":37},"2019-12-04",{"date":715,"type":23},"2026-12-07",{"name":717,"class":44},"Nicholas Breitborde"]