[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,44,70,101,139,164,187,221,250,272,304,332,351,374,398,430,455,486,518,546,569,600,638,661,687],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100524364","cerebellar-modulation-of-cognition-in-psychosis-100524364",false,"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.","ALL","18 Years","55 Years",{"count":20,"type":21},95,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30],"Schizophrenia","Schizoaffective Disorder","Bipolar Disorder I","Psychosis","RECRUITING","2026-08-18",{"date":34,"type":35},"2026-08-20","ACTUAL",{"date":37,"type":35},"2024-07-31",{"date":39,"type":21},"2029-12",{"name":41,"class":42},"Mclean Hospital","OTHER",2,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100652689","group-dbt-skills-training-for-first-episode-psychosis-100652689","NCT07777315","Group DBT Skills Training for First Episode Psychosis","Group Dialectical Behaviour Therapy (DBT) Skills Training for Individuals With First Episode Psychosis: a Feasibility Study","Inclusion Criteria:\n\n1. Be 14-35 years old.\n2. All gender identities are eligible to participate.\n3. Being competent as demonstrated by comprehension of the study procedures, risks, benefits and their rights as a volunteer in the research study and willing to consent to study participation.\n4. Meets criteria for a psychotic spectrum disorder as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum disorder, or other unspecified schizophrenia spectrum disorder), or bipolar disorder with psychotic features, and is within 3 years of their initial diagnosis.\n\nExclusion Criteria:\n\n1. Diagnosis of intellectual disability previously documented in the patient chart.\n2. Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).\n3. Receiving any additional structured psychotherapy interventions during the study period.","14 Years","35 Years",{"count":54,"type":21},32,[24],"Psychosis is a serious mental health condition that can affect how a person thinks, feels, and functions in daily life, often making it harder to maintain relationships, continue education, or work. Even with standard treatment, many people continue to experience emotional distress, depression, anxiety, and difficulty coping with strong emotions. These challenges can worsen recovery, increase the risk of substance use and suicidal behaviour, and place a significant burden on individuals, families, and the healthcare system.\n\nDialectical Behaviour Therapy (DBT) is a skills-based psychological treatment that helps people manage emotions, tolerate distress, and improve relationships. Although DBT has been effective in other mental health conditions, it has not been well studied in people with first-episode psychosis.\n\nThis study will evaluate an 8-week group DBT skills training adapted for individuals with first-episode psychosis. The study aims to assess whether the program is acceptable and feasible to deliver, and whether it may improve emotion regulation, mood, resilience, and functioning. Findings will inform whether a larger clinical trial of this intervention should be conducted.",[30],[30,59,60],"DBT","Group therapy","NOT_YET_RECRUITING","2026-08-17",{"date":34,"type":35},{"date":65,"type":21},"2026-09-15",{"date":67,"type":21},"2027-12-30",{"name":69,"class":42},"Centre for Addiction and Mental Health",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":100},"100533133","ketogenic-and-nutritional-interventions-for-first-episode-bipolar-disorder-100533133","NCT06221852","Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder","A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.","Inclusion Criteria:\n\n* Between the ages of 18 and 45.\n* Ability to adhere to study diets.\n* Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.\n* Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening\n* Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindication to magnetic resonance (MR) scan (including claustrophobia)\n* Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)\n* Current DSM-5 substance use disorder\n* Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception\n* Have a body weight of over 350 lbs or a body mass index (BMI) \\\u003C20\n* Score above 15 on the Young Mania Rating Scale (YMRS)\n* History of significant head injury\n* Current cancer diagnosis\n* Current diagnosis of type 1 or type 2 Diabetes Mellitus\n* History of gastric bypass surgery or any weight loss surgery\n* Concomitant treatment with Propofol\n* Familial hypercholesterolemia","45 Years",{"count":79,"type":21},50,[24],"This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.",[83,30,28],"Bipolar I Disorder",[85,86,87,88,89,28,90,91,92,93],"First episode psychosis","Ketogenic Diet","Keto","Brain energy metabolism","Insulin resistance","Bipolar Disorder","Magnetic resonance spectroscopy (MRS)","Redox","Creatine kinase","2026-08-13",{"date":62,"type":35},{"date":97,"type":35},"2024-03-12",{"date":67,"type":21},{"name":41,"class":42},1,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":16,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":43},"100651117","developing-a-recovery-oriented-suicide-prevention-program-for-young-people-at-clinical-high-risk-for-psychosis-100651117","NCT07756567","Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis","Development of a Recovery-Oriented Suicide Prevention Intervention With Peers for Clinical High Risk for Psychosis","Young Person Inclusion Criteria:\n\n* symptoms of clinical high risk for psychosis in the last two years\n* lifetime active suicide ideation and\u002For lifetime suicide behavior\n* has a caregiver willing to participate\n\nYoung Person Exclusion Criterion:\n\n* not able to read and write in English\n\nCaregiver Inclusion Criteria:\n\n* has a familial relationship with the young person participant\n* has at least 4 hours of face-to-face contact with the patient participant every week, even if they do not live together\n\nCaregiver Exclusion Criteria: None\n\n\\*\\*\\*\n\nAdministrator\u002FClinician Inclusion Criteria:\n\n* employed at the University of California, San Diego or University of California, Los Angeles early psychosis program\n\nAdministrator\u002FClinician Exclusion Criteria: None","12 Years","30 Years",{"count":111,"type":21},108,[24],"Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them. This study will develop and evaluate a recovery-oriented suicide prevention group program for young people at clinical high risk for psychosis.\n\nThe program will be led by a clinician and a peer with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person.\n\nThe study will first gather feedback from participants, caregivers, clinicians, and community advisors to refine the program. Researchers will then compare the program plus standard care with standard care alone to determine whether it improves personal recovery and increases participants' ability to remember and use suicide prevention strategies. Researchers will also collect feedback from participants and program staff to better understand how the program can be integrated into early psychosis services.",[115,116,30,117],"Clinical High Risk for Psychosis (CHR)","Suicidal Ideation","Suicidal Behavior",[119,120,121,122,123,124,125,126,127,128,129],"clinical high risk for psychosis","psychosis","early intervention","peer support","suicidal ideation","suicide","suicidal behavior","recovery","group intervention","implementation science","Hybrid Effectiveness-Implementation Trial","2026-08-10",{"date":132,"type":35},"2026-08-12",{"date":134,"type":21},"2026-08",{"date":136,"type":21},"2028-12",{"name":138,"class":42},"University of California, San Diego",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":100},"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":149,"type":21},90,[24],"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.",[30,153],"Schizophrenia Disorder",[155,156],"rTMS","Cognitive deficit","2026-08-07",{"date":130,"type":35},{"date":65,"type":21},{"date":161,"type":21},"2029-12-14",{"name":163,"class":42},"All India Institute of Medical Sciences, Bhubaneswar",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":100},"100650484","the-effect-of-combined-brain-stimulation-and-yoga-for-improving-cognitive-function-in-psychosis-100650484","NCT07747181","The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis","Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial","Inclusion Criteria:\n\n* (1) aged 18 to 65 years\n* (2) diagnosis based on SCID for schizophrenia and related disorders, psychosis, and delusional disorder with the positive symptom measured by CGI ≤ 3\n* (3) ability to understand the nature of the study and to give informed consent (The MacArthur Competence Assessment Tool for Clinical Research score ≥ 35)\n* (4) Chinese-speaking\n* (5) fewer than 10 hours of yoga and other mind-body intervention (e.g., Tai Chi, Qigong, Mindfulness) in the previous 3 months.\n\nExclusion Criteria:\n\n* (1) Severe physical diseases, such as myocardial infarction, uncontrollable severe hypertension, fracture, severe spinal problems, or contraindication for exercise\n* (2) comorbid substance dependence and seizure disorders\n* (3) pregnancy or other contraindication to fNIRS\n* (4) known history of intellectual disability or special school attendance, brain trauma, or organic brain disease\n* (5) Individuals taking Benzodiazepine will still be recruited in the project, and will be excluded from the fNIRS measure.","65 Years",{"count":173,"type":21},135,[24],"The study examines (1) the effects of active anodal (facilitatory) tDCS and yoga combined intervention on cognitive function, clinical symptoms, and quality of life domains (social function and physical wellbeing) in psychosis, and (2) the neurophysiological mechanisms underlying the effects induced by the combined intervention.",[177,30],"Cognitive Functioning","2026-08-04",{"date":180,"type":35},"2026-08-05",{"date":182,"type":35},"2026-01-01",{"date":184,"type":21},"2028-06-30",{"name":186,"class":42},"The Hong Kong Polytechnic University",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":194,"sex":16,"minAge":17,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":100},"100533339","investigating-the-effect-of-a-single-dose-of-levetiracetam-on-brain-function-chemistry-and-cognitive-performance-in-psychosis-risk-100533339","NCT06224530","Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk","LEVHIPPRO","CHR-P inclusion criteria\n\n1. Age range 18-40 years\n2. Capacity to consent to participation in the study\n3. Inclusion into attenuated psychosis group as assessed by the CAARMS\n4. Scores 3-5 on CAARMS unusual thought content or non-bizarre ideas subscales\n\nCHR-P exclusion criteria:\n\n1. Past episode of psychosis\n2. Current exposure to drugs with strong GABAergic or glutamatergic effects (benzodiazepines, anticonvulsants, mood stabilisers, zopiclone, zolpidem, ketamine, opiates, atomoxetine, memantine)\n3. Current\u002Frecent exposure to any antipsychotic medication\n4. Diagnosis of any neurological disorder, including epilepsy\n5. Current pregnancy\u002Fbreastfeeding\n6. Severe renal impairment\n7. Known allergy to levetiracetam\n8. Contraindication to MRI scanning\n9. IQ\\\u003C70 as determined with WAIS-III\n10. CHR-P individuals are not deemed to have a full-blown mental health disorder. However, in the event that a CHR-P individual is acutely ill and lacking capacity to consent, they will not be approached to take part in this study.\n\nHC inclusion criteria\n\n1. Age range 18-40 years\n2. Capacity to consent to participation in the study\n\nHC exclusion criteria:\n\n1. Personal history of mental health conditions\n2. Any first-degree relative with a psychotic disorder\n3. Diagnosis of any neurological disorder, including epilepsy\n4. Currently pregnant, breastfeeding, or trying to conceive\n5. Current exposure to drugs with strong GABAergic or glutamatergic effects (benzodiazepines, anticonvulsants, mood stabilisers, zopiclone, zolpidem, ketamine, opiates, atomoxetine, memantine)\n6. Current\u002Frecent exposure to any antipsychotic medication\n7. Contraindication to MRI scanning\n8. IQ\\\u003C70 as determined with WAIS-III",true,"40 Years",{"count":197,"type":21},69,[24],"Background\n\nPsychosis is a mental health condition that affects around 3 in 100 people in their lifetime. Most treatments for psychosis target a brain chemical called dopamine but they don't work for everyone and don't address many of the symptoms.\n\nPeople with psychosis and people at risk of developing psychosis show differences in a part of the brain called the hippocampus, such as smaller size and increased activity. This hyperactivity may be associated with cognitive difficulties (thinking and memory).\n\nThe basis of this hippocampal hyperactivity is thought to be a deficit in excitation and inhibition of brain cells. Excitation causes brain cells to send signals more frequently, and inhibition causes cells to send signals less frequently. A balance between these signals is important for the brain, including the hippocampus, to function properly.\n\nApproach\n\nLevetiracetam is a medication that is widely used to treat epilepsy and which helps balance excitation-inhibition in the brain. We will use brain imaging, using Magnetic Resonance Imaging (MRI), to test if levetiracetam can help reduce hippocampal hyperactivity, alter connectivity and change levels of brain chemicals in people who are at risk of developing psychosis.\n\nParticipants (18-40 years), identified as at risk of psychosis through the Outreach and Support in South London (OASIS) teams, will attend an initial visit at the Institute of Psychiatry, Psychology \\& Neuroscience. This will involve questions about experiences and feelings, assessment of thinking and memory, and a blood test. They will then attend two scanning visits at the Centre for Neuroimaging Sciences, during which they will take capsules of either levetiracetam or placebo (in a randomised order) before having a 60 mins MRI scan. The MRI scan will look at blood flow to the hippocampus, resting activity, activity during a cognitive task and levels of brain chemicals.\n\nA case-control sample of 33 healthy individuals aged 18-40 will be recruited from Greater London. We will recruit a healthy control (HC) sample to establish the presence of hippocampal dysfunction in our CHR-P group by comparing the MRI data for CHR-P under the placebo condition with that of the HC sample. The HC individuals will attend the screening visit and one scanning visit. They will not receive any medication.\n\nFunded by the Wellcome Trust and conducted by King's College London researchers, the study spans 2-3 months per participant.\n\nImpact\n\nOur study will provide important evidence about how levetiracetam affects brain function, and how this relates to cognition. This knowledge may lead to innovative approaches for understanding and treating psychosis early.",[30],[202,203,204,205,206,207,208,209,210,211,212],"Clinical high risk","Levetiracetam","Psychosis risk","Neuroimaging","Hippocampus","GABA","Glutamate","SV2A","Experimental medicine","Magnetic Resonance Spectroscopy","Magnetic Resonance Imaging","2026-08-03",{"date":180,"type":35},{"date":216,"type":35},"2024-07-19",{"date":218,"type":21},"2026-08-30",{"name":220,"class":42},"King's College London",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":249},"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), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). 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":229,"type":21},480,[24],"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.",[233,234,30],"Mental Health","Oral Health Care",[236,237,238],"Mouth Matters","Dentistry","mental health","2026-07-24",{"date":241,"type":35},"2026-07-27",{"date":243,"type":35},"2026-05-01",{"date":245,"type":21},"2029-07-31",{"name":247,"class":248},"Lancashire and South Cumbria NHS Foundation Trust","NETWORK",5,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":43},"100486732","determining-the-role-of-social-reward-learning-in-social-anhedonia-100486732","NCT05617898","Determining the Role of Social Reward Learning in Social Anhedonia","Determining the Role of Social Reward Learning in Social Anhedonia in First-Episode Psychosis Using Motivational Interviewing in a Perturbation-Based Neuroimaging Approach","SAMI","Inclusion Criteria:\n\n* Age 18-35 years\n* A first episode of a psychotic illness that began within the past three years\n* Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder\n* Taking 2nd generation antipsychotic medications\n* Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading\n* Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning\n* Sufficient fluency in English to comprehend testing procedures\n* Corrected vision of at least 20\u002F30\n\nExclusion Criteria:\n\n* No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)\n* No evidence of moderate or severe alcohol or substance use disorder in the past 3 months\n* No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury\n* For females: no current pregnancy\n* No sedatives or anxiolytics on the day of assessment\n* No medication change 3 weeks prior to enrollment",{"count":259,"type":21},152,[24],"This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.",[30],[264],"social anhedonia, social reward learning, fMRI, sensitivity to reward",{"date":241,"type":35},{"date":267,"type":35},"2023-06-14",{"date":269,"type":21},"2027-11",{"name":271,"class":42},"University of Alabama at Birmingham",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":283,"conditions":284,"keywords":291,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":100},"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":280,"type":21},24,[282],"PHASE3","The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are:\n\n* Does a single dose of modafinil change how people with psychosis play the brain games?\n* Does a single dose of d-serine change how people with psychosis play the brain games?\n* Does a single dose of modafinil change brain activity?\n* Does a single dose of d-serine change brain activity?\n\nParticipants will:\n\n* Complete an interview and self-report questionnaires.\n* Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.\n* Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart.\n* Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.\n* Play brain games on a computer that measure decision making, thinking, and problem solving skills",[30,153,28,285,286,287,288,289,290],"Major Depressive Disorder With Psychotic Features","Bipolar Disorder With Psychotic Features","Psychosis NOS","Schizophreniform Disorder","Psychotic Disorder","Cognition",[290,292,293,294],"Decision Making","fMRI","Psychosis spectrum disorders","2026-07-22",{"date":297,"type":35},"2026-07-23",{"date":299,"type":35},"2026-07-17",{"date":301,"type":21},"2030-04-30",{"name":303,"class":42},"University of Minnesota",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":312,"targetDuration":314,"studyType":315,"phases":4,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":43},"100648154","topus---testing-an-implemented-intervention-to-reduce-duration-of-untreated-psychosis-100648154","NCT07716969","TOPUS - Testing an Implemented Intervention to Reduce Duration of Untreated Psychosis","Duration of Untreated Psychosis Revisited - Testing the Effect of Early Detection Services on the Duration of Untreated Psychosis. the TOPUS Study","TOPUS","Inclusion Criteria:\n\n18 or older In treatement in an OPUS treatment center in The Capital Region or Region Zealand.\n\nStarted OPUS treatment within the last 9 months Suspected to have a psychotic disorder within the ICD 10 Schizophrenia spectrum (DF2X, excluding schizotypal disorder and schizophrenia simplex) Able to communicate adequately regarding symptoms and functioning in Danish or English.\n\n\\-\n\nExclusion Criteria:\n\n* IQ bellow 70 I primary diagnoses of drug or alcohol dependency",{"count":313,"type":21},250,"18 Months","OBSERVATIONAL","This study examines whether an early-detection program for psychosis can shorten the time patients remain untreated after the first appearance of psychotic symptoms, and whether such a reduction improves later functioning for people with first-episode schizophrenia.\n\nPsychosis involves symptoms such as hallucinations and delusions. When these symptoms are recognized and treatment begins, most patients improve. However, many individuals live with psychotic symptoms for months-or even longer-before receiving care. This period is known as the duration of untreated psychosis (DUP). A long DUP has repeatedly been linked to poorer long-term outcomes, but it is still unclear whether DUP itself causes worse outcomes or simply reflects different illness courses.\n\nIn Denmark, Region Zealand has implemented a large-scale early-detection effort. This includes public awareness campaigns and a specialized team that identifies people with emerging psychosis and helps them start treatment quickly. The Capital Region of Denmark provides usual care without these additional initiatives. This situation makes it possible to compare two regional systems that differ in their approach to early detection but provide the same specialized treatment once patients enter care.\n\nThe study follows a quasi-experimental design, recruiting adults (18+) who receive a first diagnosis of a schizophrenia-spectrum disorder within the OPUS early-intervention programs in the two regions. No interventions are assigned by the research team; participants receive standard clinical care. Researchers conduct interviews to establish how long psychotic symptoms were present before treatment began and to assess functioning and symptoms over a two-year follow-up period. Functioning, symptoms, cognition, and treatment factors will be examined at baseline and at follow-ups.\n\nThe study addresses three questions:\n\nWhether early-detection efforts in Region Zealand reduce the duration of untreated psychosis compared with usual detection.\n\nWhether a shorter duration of untreated psychosis leads to better functional and clinical outcomes fifteen months after treatment begins.\n\nHow DUP can best be defined and measured so that it reliably predicts later outcomes.\n\nResults may provide evidence for whether early-detection services improve timely access to care and whether reducing the duration of untreated psychosis contributes to better long-term functioning. The study may also help establish clearer international standards for how DUP should be measured in both research and clinical practice.",[30,318,319],"Schizo Affective Disorder","SCHIZOPHRENIA 1 (Disorder)",[321,322,30,27],"Duration of Untreated Psychosis","Early Detection","2026-07-16",{"date":325,"type":35},"2026-07-21",{"date":327,"type":35},"2024-03-01",{"date":329,"type":21},"2028-07-31",{"name":331,"class":42},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":194,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":100},"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":339,"type":21},120,[24],"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.",[30,27],"2026-07-15",{"date":323,"type":35},{"date":346,"type":35},"2022-07-13",{"date":348,"type":21},"2027-01",{"name":350,"class":42},"Massachusetts General Hospital",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":16,"minAge":358,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":100},"100612332","a-case-series-of-culturally-adapted-cbtp-for-black-people-in-the-uk-100612332","NCT07252206","A Case Series of Culturally-adapted CBTp for Black People in the UK","Culturally-adapted Cognitive-behavioural Therapy for Black Sub-Saharan African and Caribbean People Experiencing Psychosis: A Case Series","Inclusion Criteria:\n\n* Service users who identify as Black British, Black Caribbean, Black African, African-Caribbean or Mixed African\u002FCaribbean with at least one parent and\u002For grandparent born in a Sub-Saharan African or Caribbean country\n* People with a current ICD-10 schizophrenia spectrum disorder diagnosis, or who are currently receiving or have received support from an Early Intervention in Psychosis team\n* 16 years or older\n* Sufficient understanding of English to complete study measures and engage with CBTp\n\nExclusion Criteria:\n\n* Current, primary diagnosis of substance use disorder\n* Organic aetiology of psychosis\n* Lacking capacity to provide full informed consent\n* Currently experiencing a mental health crisis (i.e., are open to a home-based treatment team; are currently under Section of the Mental Health Act or have been under Section in the past 3 months) or immediate high risk to self or others (i.e., current suicidal intent or plans; unmanaged and intense non-suicidal self-injury)\n* Currently receiving CBTp or received CBTp within the preceding 3 months\n* Unwilling to participate in culturally-adapted CBTp","16 Years",{"count":360,"type":21},6,[24],"The goal of this case series study is to learn if culturally-adapted cognitive-behavioural therapy is practical, acceptable and safe among Black Sub-Saharan African and Caribbean people experiencing psychosis. The main question it aims to answer is:\n\nIs culturally-adapted CBT for psychosis feasible, acceptable to and safe for Black Sub-Saharan African and Caribbean people experiencing psychosis?\n\nParticipants will be asked to:\n\n* Answer some questionnaires about how things are at the moment\n* Attend up to 16 sessions of therapy\n* Answer the same questionnaires to see what has changed, if anything\n* Complete a semi-structured interview about their expectations and experience of therapy",[30,364],"Schizophrenia Spectrum Disorders","2026-07-08",{"date":367,"type":35},"2026-07-10",{"date":369,"type":35},"2026-02-24",{"date":371,"type":21},"2026-12",{"name":373,"class":42},"University of Manchester",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":16,"minAge":51,"maxAge":109,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":100},"100600144","mentalization-based-treatment-mbt-in-help-seeking-youths-with-a-clinical-high-risk-condition-for-psychosis-chr-p-100600144","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.",{"count":383,"type":21},212,[24],"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.",[30],[30,388,389],"MBT","Mentalization-Based Treatment","2026-07-07",{"date":365,"type":35},{"date":393,"type":35},"2025-08-01",{"date":395,"type":21},"2028-08-31",{"name":397,"class":42},"Marco Armando",{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":429},"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.","90 Years",{"count":407,"type":21},325,[282],"The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.",[411,30],"Alzheimer Disease",[413,414,415,416,30,417,418],"Alzheimer disease","Alzheimer's disease","Alzheimer's","Dementia","Alzheimer's disease psychosis","Alzheimer's disease psychosis with or without agitation","2026-06-29",{"date":421,"type":35},"2026-06-30",{"date":423,"type":35},"2026-03-25",{"date":425,"type":21},"2028-03-20",{"name":427,"class":428},"Bristol-Myers Squibb","INDUSTRY",22,{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":171,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":454,"locationsCount":100},"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",{"count":439,"type":21},60,[24],"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.",[443,319,30],"Schizophrenia Prodromal",[445,446,120,447],"negative symptoms","schizophrenia","digital health","2026-06-23",{"date":450,"type":35},"2026-06-24",{"date":134,"type":21},{"date":453,"type":21},"2028-08",{"name":271,"class":42},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":471,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":100},"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":464,"type":21},10,[24],"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.",[30,468,469,470],"Anxiety","Depression","Rumination",[472,473,30,474,475,476,477],"Mirco-Randomized Study","Mobile Health","Digital Mental Health","Negative Mood","Digital Phenotyping","Passive Sensors","2026-06-22",{"date":480,"type":35},"2026-06-25",{"date":482,"type":21},"2026-08-01",{"date":484,"type":21},"2027-06-01",{"name":41,"class":42},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":16,"minAge":493,"maxAge":109,"enrollmentInfo":494,"targetDuration":4,"studyType":315,"phases":4,"briefSummary":496,"conditions":497,"keywords":501,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"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":495,"type":21},215,"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",[498,30,499,443,500],"Psychotic Disorders","Schizophrenia and Related Disorders","Diagnosis, Psychiatric",[498,500,443,502,503,504,505,506,507],"Ultra High Risk","Prediction Of Psychosis","Machine Learning","Automated Language Analysis","Semantic Coherence","Syntaxic Complexity","2026-05-29",{"date":510,"type":35},"2026-06-02",{"date":512,"type":35},"2018-05-18",{"date":514,"type":21},"2030-05-02",{"name":516,"class":42},"University Hospital, Brest",3,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":100},"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":527,"type":21},15,[24],"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.",[30,319,499],[532,30,533,534,535,536,537],"Emotion regulation","Virtual reality","Schizophrenia spectrum disorders","Virtual reality exposure therapy","Psychotherapy","Dialectical behaviour therapy","2026-05-28",{"date":540,"type":35},"2026-06-03",{"date":542,"type":21},"2027-09-01",{"date":544,"type":21},"2028-11-01",{"name":220,"class":42},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":194,"sex":16,"minAge":17,"maxAge":171,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":559,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":100},"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.",{"count":553,"type":21},100,[24],"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.",[557,558,30,155],"Cannabis Use","SCHIZOPHRENIA",[560,446,155,561],"cannabis use","brain stimulation",{"date":510,"type":35},{"date":564,"type":35},"2026-01-15",{"date":566,"type":21},"2027-12-31",{"name":568,"class":42},"Vanderbilt University Medical Center",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":194,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":100},"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":578,"type":21},106,[24],"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.",[582,30],"First Episode Psychosis (FEP)",[120,584,585,586,587,588,207,589,590],"cognition","glutamate","transcranial direct current stimulation","fMRS","first episode psychosis","working memory","magnetic resonance spectroscopy","2026-04-28",{"date":593,"type":35},"2026-05-04",{"date":595,"type":35},"2026-02-09",{"date":597,"type":21},"2027-08",{"name":599,"class":42},"University of Nottingham",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":608,"minAge":77,"maxAge":18,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":100},"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",{"count":610,"type":21},103,[612],"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).",[469,30,615],"Anhedonia",[617,615,618,619,620,621,622,623,624,625,626,627,628,629],"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":631,"type":35},"2026-04-29",{"date":633,"type":35},"2022-04-20",{"date":635,"type":21},"2026-12-31",{"name":637,"class":42},"University of North Carolina, Chapel Hill",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":16,"minAge":493,"maxAge":109,"enrollmentInfo":646,"targetDuration":4,"studyType":22,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":660},"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":647,"type":21},500,[282],"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.",[30],"2026-04-15",{"date":653,"type":35},"2026-04-20",{"date":655,"type":35},"2023-12-15",{"date":657,"type":21},"2029-02-15",{"name":659,"class":42},"Centre Hospitalier St Anne",13,{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":16,"minAge":358,"maxAge":109,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":669,"briefSummary":670,"conditions":671,"keywords":674,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":43},"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":79,"type":21},[24],"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.",[30,672,673],"Alcohol Use Disorder","Cannabis Use Disorder",[675,676,677,120],"alcohol","cannabis","action based cognitive remediation","2026-04-01",{"date":680,"type":35},"2026-04-07",{"date":682,"type":21},"2026-03-27",{"date":684,"type":21},"2028-03-31",{"name":686,"class":42},"Nova Scotia Health Authority",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":694,"enrollmentInfo":695,"targetDuration":4,"studyType":22,"phases":696,"briefSummary":697,"conditions":698,"keywords":699,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":703,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":43},"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":280,"type":21},[612],"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",[30,557],[676,700,701,702],"metformin","early phase psychosis","potency",{"date":680,"type":35},{"date":705,"type":35},"2025-03-18",{"date":707,"type":21},"2026-12-01",{"name":686,"class":42}]