[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-and-related-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-and-related-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,50,85,116,148,175,201,225,249,274,297,325,353,378,405,427,459,492],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100326055","semantic-and-syntactic-computerized-analysis-of-free-speech-100326055",false,"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","ALL","15 Years","30 Years",{"count":20,"type":21},215,"ESTIMATED","OBSERVATIONAL","Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques",[25,26,27,28,29],"Psychotic Disorders","Psychosis","Schizophrenia and Related Disorders","Schizophrenia Prodromal","Diagnosis, Psychiatric",[25,29,28,31,32,33,34,35,36],"Ultra High Risk","Prediction Of Psychosis","Machine Learning","Automated Language Analysis","Semantic Coherence","Syntaxic Complexity","RECRUITING","2026-05-29",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2018-05-18",{"date":45,"type":21},"2030-05-02",{"name":47,"class":48},"University Hospital, Brest","OTHER",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"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","18 Years",{"count":60,"type":21},15,"INTERVENTIONAL",[63],"NA","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.",[26,66,27],"SCHIZOPHRENIA 1 (Disorder)",[68,26,69,70,71,72,73],"Emotion regulation","Virtual reality","Schizophrenia spectrum disorders","Virtual reality exposure therapy","Psychotherapy","Dialectical behaviour therapy","NOT_YET_RECRUITING","2026-05-28",{"date":77,"type":41},"2026-06-03",{"date":79,"type":21},"2027-09-01",{"date":81,"type":21},"2028-11-01",{"name":83,"class":48},"King's College London",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":61,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":84},"100399257","phase-4-extended-alternate-day-antipsychotic-dosing-100399257","NCT04478838","\"Extended\" (Alternate Day) Antipsychotic Dosing","\"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: \"Extended\" Antipsychotic Dosing\"","Inclusion Criteria:\n\n(i) A primary diagnosis of a Schizophrenia Spectrum or Other Psychotic Disorder as defined by the DSM-5 diagnosis and confirmed by the MINI (Version 7.0.2)\n\n(ii) age 18 or older\n\n(iii) female participants of childbearing potential must be using a reliable method of contraception and have a negative pregnancy test at the time of enrolment and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study. Male participants must not father a baby during their time in the study\n\n(iv) ability to communicate in English\n\n(v) capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent\n\n(vi) stabilized as outpatients with a single oral AP (risperidone or olanzapine or paliperidone\\*) at the same dose for ≥3 months i. On a prescribed risperidone dose of between 1-6mg, or a prescribed olanzapine dose of between 5-20mg, or a prescribed paliperidone 3-12mg\n\n(vii) evidence of adherence with current AP treatment\n\nExclusion Criteria:\n\n(i) exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)\n\n(ii) Current diagnosis of substance use disorder according to DSM-5 criteria (verified through the MINI for Psychotic Disorders (Version 7.0.2) and a positive drug screen for street and \u002For prescription drugs not prescribed to the participant by treating physicians\n\n(iii) ECT within the last 3 months\n\n(iv) pregnancy or lactation\n\n(v) neurological condition (dementia including Alzheimer's disease, multiple sclerosis, epilepsy, stroke, or traumatic brain injury)\n\n(vi) allergy to the study drugs and their excipients\n\n(vii) allergy (e.g., galactosaemia) or severe intolerance to lactose\n\n(viii) negative urine drug screen result for Olanzapine or Risperidone or Paliperidone (if applicable)",{"count":93,"type":21},120,[95],"PHASE4","The study wishes to examine whether \"extended\" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects.\n\nParticipants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50\u002F50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing.\n\nThis study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office.\n\nThe investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.",[27,98,99,100],"Drug Administration Schedule","Drug Therapy","Antipsychotic Agents",[102,103,104,105,106],"Extended Dosing","Alternate day dosing","Olanzapine","Risperidone","Paliperidone","2026-04-08",{"date":109,"type":41},"2026-04-13",{"date":111,"type":41},"2022-06-06",{"date":113,"type":21},"2028-09-30",{"name":115,"class":48},"Centre for Addiction and Mental Health",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":16,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100625183","social-isolation-and-aging-in-schizophrenia-100625183","NCT07419321","Social Isolation and Aging in Schizophrenia","The Impact of Social Isolation on Aging Health in Schizophrenia","SIAS","Inclusion and exclusion criteria for participants with SZ:\n\n* DSM-IV or V diagnosis of a SZ related disorder (295.x, 297.1, 298.8, or 298.9; e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, but not psychotic disorder that is solely substance induced) based on clinical interview;\n* Between 40 and 70 years of age at time of study recruitment;\n* Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;\n* Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;\n* No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);\n* No history of IQ \\\u003C 70, or developmental disability based on chart review;\n* Clinically stable (i.e., no inpatient hospitalizations for three months prior to enrollment, no changes in medication in the four weeks prior to enrollment;\n\nThe inclusion and exclusion criteria for sibling participants in this study will be:\n\n* No history of any DSM IV\u002FV Axis I or axis II diagnosis that is known to be associated with social functioning (e.g. severe mood disorder, schizoaffective personality disorder, autism spectrum disorder);\n* Between 40 and 70 years of age at time of study recruitment;;\n* Participant was enrolled in a previous research study between the ages of 20-55, and this study took place at least 5 years ago;\n* Able to understand the spoken language of the participating country sufficiently to comprehend testing procedures;\n* No history of serious head injury (i.e., loss of consciousness longer than 1 hour, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury);\n* No history of IQ \\\u003C 70, or developmental disability based on chart review;\n* Clinically stable (i.e., no inpatient hospitalizations for three months prior to enrollment, no changes in medication in the four weeks prior to enrollment",true,"40 Years","70 Years",{"count":128,"type":21},650,"Individuals diagnosed with schizophrenia and related psychotic disorders (SZ) exhibit a markedly elevated risk of premature mortality, with a 10-20-year shorter lifespan relative to the general population. Increased mortality rates in SZ are largely attributable to the early manifestation of medical conditions that normally occur later in life, a process known as 'accelerated aging'. While unhealthy lifestyle behaviors, such as smoking and unhealthy diet, account, in part, for accelerated aging in SZ, the excess of physical comorbidities cannot be solely attributed to these factors. Remarkably, the direct adverse health effects of key clinical characteristics of SZ have rarely been considered. In the general population, the absence of social contact is known to pose enormous challenges for physical health, especially at older ages. Given that social isolation is a persistent and disabling feature of SZ, it is possible that this behavior may contribute to the premature manifestation of health conditions in SZ. Building on rich pilot data pointing to significant associations between social isolation and long-term perceived health in SZ, the overarching goal is to test whether and how social isolation contributes to the health challenges of individuals with SZ as they age. With participants from Europe (EU-GEI) and the US (Olin Neuropsychiatry Research Center), the researchers will create a longitudinal database of 650 participants, including 500 individuals with SZ, and 150 of their unaffected siblings. The researchers will apply an accelerated longitudinal design by reassessing and by examining medical records of research participants who were first evaluated between the ages of 20-55 and are now 40-70 years of age, a period when many medical conditions and health problems tend to manifest. The researchers will determine the age-related association between social isolation and adverse health outcomes in SZ, test for familiality, directionality, and factors moderating this association, and determine the extent to which the COVID-19 pandemic and the resulting imposed lockdowns impacted health in SZ. The researchers will consider generalizability across countries, sexes, and race\u002Fethnicities. The rationale for the proposed research is that in order to facilitate much-needed targeted therapies to prevent early mortality in SZ, the researchers need to better understand factors that contribute to the excess of medical comorbidities in SZ. The central hypothesis is that social isolation, a common and persistent characteristic of SZ, contributes to the excess of physical comorbidities in SZ. To meet the overall goal, the following aims are: (1) Determine the association between social isolation and adverse health outcomes in SZ; (2) Test for the directionality, and moderating factors, of the association between social isolation and health outcomes in SZ, and; (3) Examine whether the COVID-19 pandemic modified associations between social isolation and health outcome in SZ. This study will be the first to comprehensively examine the health impact of social isolation in SZ. The project may show that in SZ socialization in midlife can reduce the risk for poor health outcomes and ultimately facilitate much-needed preventive targeted therapies to reduce early-age mortality in SZ",[27],[132,133,134,135,136,137],"schizophrenia","psychosis","social isolation","physical health","longitudinal trajectory","siblings","2026-02-10",{"date":140,"type":41},"2026-02-19",{"date":142,"type":41},"2024-01-09",{"date":144,"type":21},"2027-07",{"name":146,"class":48},"Icahn School of Medicine at Mount Sinai",4,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":124,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":61,"phases":156,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100519456","digital-implementation-support-to-achieve-uptake-and-integration-of-task-shared-care-for-schizophrenia-in-primary-care-in-india-100519456","NCT06043778","Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India","Inclusion Criteria:\n\n* Primary diagnosis of schizophrenia per IDC-10 diagnostic criteria for research and an illness duration of greater than 12 months and overall moderate level of severity on the CGI-SCH scale\n* At least one risk factor for early mortality (e.g. hypertension, diabetes, dyslipidemia, etc)\n* Willingness to stay in the study area during the trial period\n* Ability to operate a smartphone\n\nExclusion Criteria:\n\n* Major visual impairment or inability to operate a smartphone\n* Cognitive impairment or diagnosis of dementia\n* Planning to move out of the study area in the next 12 months\n* Does not speak Hindi or Kannada",{"count":155,"type":21},240,[63],"Schizophrenia represents a significant contributor to the global burden of disease, with this burden disproportionately impacting low- and middle-income countries (LMICs). In India, the burden due to schizophrenia is further exacerbated by low access to effective psychosocial interventions aimed at promoting recovery, rehabilitation, and community tenure, as well as inadequate attention to managing co-occurring chronic medical conditions that result in significantly reduced life expectancy among those living with schizophrenia compared to the general population. A major driver of these alarming gaps in access to care for persons with schizophrenia in India is the limited capacity within primary care settings aimed at addressing the complex co-occurring mental health, physical health, and functional needs of this patient population. There now exists strong evidence demonstrating that community programs delivered in primary care and leveraging psychosocial interventions combined with linkage to specialty psychiatric services are effective for supporting treatment and recovery of schizophrenia in low-resource settings. We will leverage our existing collaboration and robust research infrastructure in both rural and urban settings in Madhya Pradesh and Karnataka, India to conduct a hybrid type 1 effectiveness-implementation trial to evaluate whether the use of a digital platform offers added clinical benefit and can support integration of this task shared care for schizophrenia into routine primary care settings. We will address the following aims: 1) evaluate whether the use of the mindLAMP digital platform can enhance the clinical effectiveness of task-shared community-based psychosocial rehabilitation (COPSI) for individuals with schizophrenia, and 2) determine whether the addition of mindLAMP to the delivery of the COPSI program has an impact on implementation metrics when compared to delivery of COPSI alone.",[159,27,160],"Schizophrenia","Psychosocial Functioning",[132,162,163,164,165,166],"psychosocial intervention","digital technology","task sharing","implementation","smartphone app",{"date":168,"type":41},"2026-02-12",{"date":170,"type":21},"2026-07",{"date":172,"type":21},"2029-03-31",{"name":174,"class":48},"Harvard Medical School (HMS and HSDM)",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":61,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":84},"100622017","clay-therapy-in-schizophrenia-patients-100622017","NCT07378150","Clay Therapy in Schizophrenia Patients","The Effect of Clay Therapy on Functional Improvement and Individual and Social Performance in Schizophrenic Patients","Inclusion Criteria:\n\n* Having been diagnosed with schizophrenia,\n* Being aged 18 or over,\n* Having completed at least primary school education,\n* Having achieved treatment compliance,\n* Currently undergoing pharmacological treatment,\n* Being in remission,\n* Having attended the Community Mental Health Centre regularly over the past year,\n* Having agreed to participate in the study\n* Scoring 20 points or higher on the Mini Mental State Examination\n\nExclusion Criteria:\n\n* Being under 18 years of age,\n* Not having an education,\n* Not having a diagnosis of schizophrenia,\n* Not adhering to treatment,\n* Not taking pharmacological treatment regularly,\n* Being in an acute attack\u002Factive phase,\n* Lacking insight",{"count":183,"type":21},17,[63],"In recent years, art therapies have been discussed for their positive effects on mental disorders. One such therapy, clay therapy, is being studied to examine its effect on the functional recovery and individual and social performance of schizophrenia patients undergoing pharmacological treatment.",[27],[132,188,189,190,191],"clay therapy","Functional Recovery","Individual and Social Performance","art therapy","2026-01-29",{"date":194,"type":41},"2026-01-30",{"date":196,"type":41},"2025-12-01",{"date":198,"type":21},"2026-02-20",{"name":200,"class":48},"Kutahya Health Sciences University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":208,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":61,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":84},"100490827","rtms-for-depressive-positive-and-negative-symptoms-and-physiological-indices-of-schizophrenia-patients-100490827","NCT05671185","rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients","Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients","Inclusion Criteria:\n\n* Age ≥ 20 years\n* Able to give informed consent\n* Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5\n* Has a score ≥ 7 on Calgary depression scale for schizophrenia\n* The principal psychotropic agents are not changed within one month of the first session of rTMS\n\nExclusion Criteria:\n\n* DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months\n* Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE \\\u003C 15)\n* With electronic and\u002For magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator \\[ICD\\], cerebral shunts, cochlear implant, etc.)\n* With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.)\n* Pregnant, or has a pregnancy plan within 3 months\n* With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion\n* Received rTMS or iTBS treatment within 3 months\n* Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results","20 Years",{"count":210,"type":21},180,[63],"Around 40% of schizophrenia patients present depressive symptoms, which are associated with elevated suicide and violence risk and poor prognosis and quality of life. Recent meta-analysis showed the effect size of antidepressants for depressive symptoms of schizophrenia patients was as low as 0.25, so new therapeutic approach is warranted.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive, anesthesia-free brain stimulation therapy for treatment refractory depression. Currently, rTMS is classified as high-frequency stimulation (\\>5Hz, usually 10Hz or 20Hz) and low-frequency inhibition (usually 1Hz). Intermittent theta burst stimulation (iTBS) is a new variant of rTMS, with stimulation frequency as high as 50Hz. Compared with high-frequency rTMS, iTBS has similar therapeutic effect and shorter stimulation duration. Up to now, studies exploring treatment effect of rTMS or iTBS for schizophrenia patients mainly focused on negative symptoms rather than depressive symptoms. Therefore, this study aims to explore treatment effect of rTMS or iTBS of depressive symptoms, negative symptoms, cognitive function and physiological indices for schizophrenia patients.",[27],[159,215],"repetitive transcranial magnetic stimulation","2026-01-20",{"date":218,"type":41},"2026-01-22",{"date":220,"type":41},"2022-12-01",{"date":222,"type":21},"2028-12",{"name":224,"class":48},"National Taiwan University Hospital",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":126,"enrollmentInfo":233,"targetDuration":4,"studyType":61,"phases":235,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":84},"100485594","phase-3-intensified-pharmacological-treatment-for-schizophrenia-major-depressive-disorder-and-bipolar-depression-after-a-first-time-treatment-failure-100485594","NCT05603104","Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure","A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.","INTENSIFY","Inclusion Criteria:\n\n1\\. In- or out patients, at least 18 years of age up until 70 (SZ study sample), 65 years (MDD study sample) and no limit for the BD study..\n\nBeing willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.\n\n3\\. Female subjects of child bearing potential must be willing to ensure that they use effective contraception during the trial and as per the requirements in the protocol (section 8.2.1).Male subjects that will use valproate acid during the trial must use effective contraceptive measures during the trial.\n\n4\\. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder (without psychotic features) or bipolar depression (bipolar disorder type I and II currently in a depressive episode), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).\n\n5\\. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well.\n\n6\\. Subject and clinician intend to change pharmacotherapeutic treatment. 7. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment.\n\n* The minimum symptom severity threshold for SZ subjects is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5.\n* The minimum symptom severity threshold for MDD is a score of ≥ 20 on the Montgomery Åsberg Depression Rating Scale (MADRS)\n* The minimum symptom severity threshold for BD is a score of ≥20 on the Montgomery Åsberg Depression Rating Scale (MADRS)\n* For all study samples: Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).\n\nExclusion criteria:\n\n1. Being pregnant or breastfeeding.\n2. Subject has failed previously on the EIPT study medication (i.e. SZ: clozapine; MDD: esketamine intranasal\u002F(es)ketamine IV) Treatment duration as ≥ 4 weeks within an efficacious dose range according to the SmPC.\n3. Subject has a known intolerance to clozapine (SZ only), esketamine intranasal\u002F (es)ketamine IV (MDD only) or quetiapine (BD only) or to all medication options for a study sample (related to the TAU treatment arms) or all EIPT medications (BD study sample).\n4. Meeting any of the contraindications of clozapine (SZ only), esketamine intranasal\u002F (es)ketamine IV (MDD only) or quetiapine (BD only), or to all medication options for a study sample (related to the TAU treatment arms), or all EIPT medications (BD study sample), as specified within the applicable SmPC.\n5. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.\n6. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial.\n7. 7\\. Subjects with active suicidal ideation with some intent to act, without specific plan (\"Yes\" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent (\"Yes\" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study\n8. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and\u002For cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and\u002For cannabis use disorder are not allowed.\n9. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n10. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance.\n11. For the SZ sample only: schizophrenia subjects cannot meet the modified Andreasen criteria for remission.\n12. For the SZ sample only: Subjects that have any clinically significant abnormal values on the local laboratory test (especially ANC\u002FWBC and liver values), electrocardiogram (ECG) or physician examinations.\n13. For the BD sample only: a score of 12 or higher on the Young Mania Rating Scale (YMRS) in order to exclude subjects with predominant manic symptoms or mixed symptoms.\n14. For the BD study sample only: Subjects with a history of antidepressant-induced mania or hypomania or recent rapid cycling (based on the medical file of the potential participant or the clinical judgment of the clinician).\n15. For the BD study sample only: Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1).",{"count":234,"type":21},1254,[236],"PHASE3","Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) when used earlier in the disease course for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.",[27,239,240],"Major Depressive Disorder","Bipolar Depression","2026-01-19",{"date":218,"type":41},{"date":244,"type":41},"2025-04-27",{"date":246,"type":21},"2028-06-30",{"name":248,"class":48},"Dr. Inge Winter",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":61,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":84},"100540213","exercise-therapy-in-mental-disorders-study-100540213","NCT06313918","Exercise Therapy in Mental Disorders-study","Inclusion Criteria:\n\n* ICD-10 schizophrenia-spectrum disorder (F2)\n* ICD-10 bipolar disorder (F3)\n* Capacity to provide informed consent.\n\nExclusion Criteria:\n\n* Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications\n* Life threatening or terminal medical conditions\n* Not able to carry out intervention or test procedures\n* Current pregnancy\n* Mothers less than 6 months post-partum.","16 Years",{"count":257,"type":21},50,[63],"The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective.",[27,261],"Bipolar Disorder",[263,264],"Exercise therapy","Effectiveness","2025-12-22",{"date":267,"type":41},"2025-12-30",{"date":269,"type":41},"2023-09-27",{"date":271,"type":21},"2026-09-26",{"name":273,"class":48},"Haukeland University Hospital",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":61,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":84},"100597559","bilateral-prefrontal-and-insular-tms-for-depression-in-schizophrenia-100597559","NCT07060066","Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia","Inclusion Criteria:\n\n* Male and female ages between ages 18-60 years.\n* Ability to give written informed consent (age 18 or above).\n* Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.\n* Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3.\n\nExclusion Criteria:\n\n* Inability to sign informed consent.\n* Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but are not limited to: stroke, repeated seizure, history of significant head trauma with cognitive sequela, CNS infection or tumor, other significant brain neurological conditions.\n* Significant alcohol or other drug use other than nicotine or marijuana dependence.\n* Inability to refrain from using alcohol and\u002For marijuana 24 hours or more prior to experiments.\n* Pregnancy, as classified by a woman of child-bearing potential who is not using a contraceptive and has missed a menstrual period; or by self-report; or by positive urine pregnancy test.\n* For MRI, inability to participate in the MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or declining to get in the scanner.\n* Failed TMS safety questionnaire.","60 Years",{"count":93,"type":21},[63],"The purpose of this study is to provide an effective repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia. Schizophrenia patients with depressive symptoms will be exposed to rTMS to improve their symptoms.",[27],[286,132,287],"transcranial magnetic stimulation","depression","2025-12-12",{"date":290,"type":41},"2025-12-17",{"date":292,"type":41},"2024-05-21",{"date":294,"type":21},"2030-06-01",{"name":296,"class":48},"The University of Texas Health Science Center, Houston",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":124,"sex":16,"minAge":58,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":61,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":84},"100602112","spark-healthy-sleep-100602112","NCT07119268","SPARK Healthy Sleep","SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes","SPARK","Inclusion Criteria:\n\n* Age ≥18 years\n* Current college enrollment\n* English fluency\n* Prodromal Questionnaire-Brief endorsement score ≥7\n* Pittsburgh Sleep Quality Index score \\>5\n* Pass validity screening questions\n\nExclusion Criteria:\n\n* Previous psychotic disorder diagnosis\n* Unable to provide informed consent","65 Years",{"count":307,"type":21},115,[63],"SPARK-Healthy Sleep is a digital mental health intervention designed to help college students who may be at risk for psychosis and experience sleep problems. About 1 in 4 college students report psychotic-like experiences (such as hearing voices or feeling paranoid), and these students often have poor sleep quality, which can worsen their mental health symptoms.\n\nThis study tests whether a single-session digital intervention can improve sleep and reduce mental health stigma in at-risk college students. The intervention is delivered through a smartphone app and takes about 30 minutes to complete. It includes educational content about mental health being on a continuum (not just \"normal\" vs \"abnormal\"), strategies to reduce stigma around seeking help, and evidence-based sleep improvement techniques based on cognitive behavioral therapy for insomnia.\n\nThe study will recruit 115 college students from Indiana University-Indianapolis who score high on measures of psychotic-like experiences and poor sleep quality. Half will receive the intervention immediately (experimental group), while the other half will wait three weeks before receiving it (control group). All participants will complete questionnaires about sleep, mental health symptoms, social functioning, and stigma at the beginning of the study and after two weeks.\n\nThe main goals are to determine if the intervention is feasible and acceptable to students, and whether it shows preliminary effectiveness in improving sleep quality, reducing stigma, and improving overall mental health outcomes. A subset of participants will also complete interviews about their experience using the intervention.\n\nThis research addresses important barriers to mental health care for college students, including stigma and limited access to services. If successful, this digital approach could provide a scalable way to help at-risk students improve their mental health and potentially prevent more serious problems from developing.",[27,311],"Sleep Disturbance",[313,314,315],"College Students","Sleep Disturbances","Psychosis-Spectrum Disorders","2025-11-06",{"date":318,"type":41},"2025-11-10",{"date":320,"type":41},"2025-10-24",{"date":322,"type":21},"2026-10-01",{"name":324,"class":48},"Indiana University",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":126,"enrollmentInfo":333,"targetDuration":4,"studyType":61,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":351,"locationsCount":352},"100512932","phase-4-the-effect-of-a-six-week-intensified-pharmacological-treatment-for-schizophrenia-compared-to-treatment-as-usual-in-subjects-who-had-a-first-time-treatment-failure-on-their-first-line-treatment-100512932","NCT05958875","The Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.","A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.","INTENSIFY SZ","Inclusion Criteria:\n\n1. In- or out patients, at least 18 years of age up until 70.\n2. Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.\n3. Female subjects of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before randomisation; section 8.2).\n4. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).\n5. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well.\n6. Subject and clinician intend to change pharmacotherapeutic treatment.\n7. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment.\n\n   * The minimum symptom severity threshold is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5.\n   * Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).\n\nExclusion criteria:\n\n1. Being pregnant or breastfeeding.\n2. Subject has used clozapine in the past.\n3. Subject has a known intolerance to clozapine or to all TAU medication options.\n4. Meeting any of the contraindications of clozapine or to all TAU medication options, as specified within the applicable SmPC.\n5. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.\n6. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial.\n7. Subjects with active suicidal ideation with some intent to act, without specific plan (\"Yes\" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent (\"Yes\" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study\n8. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and\u002For cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and\u002For cannabis use disorder are not allowed.\n9. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n10. Subjects who meet the modified Andreasen criteria for remission.\n11. Subjects that have any clinically significant abnormal values on the local laboratory test (especially ANC\u002FWBC and liver values), electrocardiogram (ECG) or physician examinations.\n12. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance",{"count":334,"type":21},418,[95],"Schizophrenia (SZ) affects approximately 4.5 million people across the European Union (EU) and is associated with annual healthcare and societal costs of 29 billion Euros. The impact on the daily life of patients is huge, ranging from frequent relapses and hospitalisations, the inability to maintain a job or continue scholing, to a low quality of life, impaired cognitive functioning, suicidal ideation and an increase morbidity rate, next to the large burden for carers 1. When diagnosed with schizophrenia or related disorder, patients are commonly prescribed antipsychotics. One-third of the schizophrenia patients are regarded treatment-resistant (TR), meaning that at least two antipsychotic trials have failed. Typically, clozapine is prescribed for TR patients, which is effective for approximately 40% of patients. Clozapine is among the most effective treatments, with the lowest all-cause mortality. Although it is among the most effective antipsychotics, it is generally not used earlier in the illness course due to a small risk of severe neutropenia\u002Fagranulocytosis, which is why patients treated with clozapine are intensely monitored. However, this small risk outweighs the burden of not receiving an effective treatment.\n\nSince clozapine is among the most effective treatments, this leads to the research question whether earlier initiation of third-line treatment ('early intensified' pharmacological treatment; EIPT) would be more beneficial than the current second-line treatments (treatment as usual; TAU). If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments, hospitalisations, and recommendations for adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs The INTENSIFY-Schizophrenia trial is part of the larger Horizon 2021 project Psych-STRATA, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, the inestigators aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression. The current protocol focuses on the sample of schizophrenia patients.",[27,338],"Early Treatment-Resistance",[159,340,341,342,343,344],"Schizoaffective disorder","Schizophreniform disorder","Clozapine","Treatment as usual","Early treatment-Resistance","2025-09-24",{"date":347,"type":41},"2025-09-26",{"date":349,"type":41},"2024-08-01",{"date":246,"type":21},{"name":248,"class":48},13,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":61,"phases":363,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":49},"100530836","phase-2-mitoq-for-early-phase-schizophrenia-spectrum-disorder-and-mitochondrial-dysfunction-100530836","NCT06191965","MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction","Double Blind, Randomized, Placebo-Controlled Study of MitoQ as Adjunctive Treatment for Patients With Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction","Inclusion Criteria:\n\n* Male or female aged 18 to 35 years old\n* Patients who have been diagnosed with one of the following schizophrenia-spectrum disorders: schizophreniform disorder, schizophrenia, schizoaffective disorder, unspecified psychosis.\n* Less than five years in treatment for psychosis (note that the duration of psychosis may be longer than 5 years, but this is more difficult to ascertain and therefore less reliable as an inclusion criterion).\n* PANSS score \\\u003C 75\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Meeting DSM-5 criteria for any substance use disorder diagnosis in the past 6 months will be exclusionary EXCEPT tobacco and mild\u002Fmoderate cannabis use disorder, which will be included\n* Any acute medical condition requiring actively changing treatment (e.g., autoimmune disorders, acute infections, HIV\u002FAIDS, cancer, renal failure, hepatic dysfunction, cardiovascular disease, or abnormal thyroid findings). Individuals with chronic medical conditions that are stable will not be excluded (e.g., person with hypothyroidism who is taking thyroid hormone replacement and has TSH levels within the normal range; person with well-managed diabetes; etc.)\n* Epilepsy or another seizure disorder\n* Intellectual disability (e.g., history of IQ \\\u003C 70).\n* Under legal guardianship\n* Not English speaking. The questionnaires, instruments, cognitive assessments used in this research study have not been translated, validated, or studied extensively in non-English-speaking individuals. For this reason, we will not enroll individuals who do not speak English to maintain validity in the study.\n* MitoQ allergy\n* Treatment with antioxidants: omega3 (fish oil), Vitamin E, Vitamin C, multivitamins, NAC (N-acetyl cysteine) within the last 14 days. If the treatment is taken without prescription, we will ask the patient to stop using it for at least 14 days to become eligible for the present study.\n* Children and adolescents, pregnant women, women who have the intention to become pregnant during the course of the study, and breastfeeding women are excluded from the study. This is because no MitoQ pharmacokinetic data are available in pediatric populations, pregnancy or breastfeeding.\n* Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilized\u002Fhysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential.\n* Enrollment of study staff, their family members, and other dependent persons","35 Years",{"count":362,"type":21},100,[364,236],"PHASE2","The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol mesylate) supplementation on cognition in 50 people with early phase schizophrenia-spectrum disorders (E-SSD) who have mitochondrial dysfunction (called high risk, or HR). Cognitive impairments in SSD can cause significant disability. Yet, there are no effective treatments for cognitive impairments in SSD. It has been shown that alterations in a certain type of brain cell (parvalbumin interneurons, or PVI) underlie cognitive deficits in SSD. These PVI, which fire at a fast rate, utilize high amounts of energy from the mitochondria and are highly vulnerable to oxidative stress. MitoQ is an antioxidant. Research has shown that, in mice, MitoQ can reduce oxidative stress in the mitochondria. The main question that this clinical trial aims to answer is:\n\n• Does MitoQ supplementation, compared to placebo, improve cognition in HR patients?\n\nSecondary questions that this clinical trial aims to answer are the following: Does MitoQ supplementation, compared to placebo:\n\n* Improve positive and negative symptoms of SSD in HR patients?\n* Improve functioning in HR patients?\n* Improve\u002Fnormalize blood markers of mitochondrial dysfunction in HR patients?\n\nThe investigators will enroll 100 individuals with E-SSD. These enrolled participants will participate in an initial screening visit to determine if they qualify for the actual clinical trial. At the screening visit, the investigators will ask about psychiatric history to determine diagnosis; ask about medical history; do a physical exam; collect blood and urine samples; do a pregnancy test; and ask participants to bring in their current medications in their original packaging so it is known what they are taking.\n\nAfter the screening visit, the investigators will invite 50 HR patients (identified with a blood test) to continue with the clinical trial. Participants who qualify for the clinical trial will be asked to:\n\n* Take a supplement (MitoQ or placebo) once per day for 12 weeks in addition to their usual medications.\n* Come in for a study visit every 4 weeks over the 16-week study period. At these study visits, the investigators will do a physical exam; ask about symptoms and side effects; take blood and urine samples; and ask questions about general health and well-being, quality of life, mental health, emotional health, and mood. At visits 1 (baseline) and 4 (12 weeks), participants will also take a cognitive assessment.",[27,367,368],"Mitochondrial Alteration","Cognitive Impairment","2025-09-22",{"date":371,"type":41},"2025-09-25",{"date":373,"type":41},"2024-06-01",{"date":375,"type":21},"2027-01-31",{"name":377,"class":48},"Mclean Hospital",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":61,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100602258","tele-group-cognitive-behavioural-family-intervention-for-individuals-with-schizophrenia-and-their-families-100602258","NCT07121166","Tele-group Cognitive Behavioural Family Intervention for Individuals With Schizophrenia and Their Families","Effectiveness of a Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families: a Mixed-method Study","tgCBFI","I. Individuals with schizophrenia-spectrum disorders\n\nInclusion Criteria:\n\n* current diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians,\n* aged 18-64, and\n* able to read and write Chinese\n\nExclusion Criteria:\n\n* having co-morbidity of learning disability, organic\u002Fneurological conditions, or substance use disorder, and\n* living in a hostel\n\nII. Family caregivers\n\nInclusion Criteria:\n\n* aged 18 or above,\n* able to read and write Chinese,\n* live with service users, and\n* nominated by the service users\n\nExclusion Criteria:\n\n* having active psychiatric conditions","64 Years",{"count":388,"type":21},200,[63],"This mixed-method study comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively study the benefits of the tgCBFI programme from the service users and their family caregivers to provide a more in-depth understanding and complement the quantitative data. The main questions it aims to answer are: Does this online tgCBFI programme reduce the expressed emotion experienced and positive and negative symptoms of individuals with schizophrenia? Does this online tgCBFI programme reduce the perceived care burden and level of mood disturbances of family caregivers?",[27],[393,394,132,395],"CBT","family intervention","telehealth","2025-08-13",{"date":398,"type":41},"2025-08-19",{"date":400,"type":21},"2025-09-01",{"date":402,"type":21},"2028-07-31",{"name":404,"class":48},"The Hong Kong Polytechnic University",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":61,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":84},"100279394","alternative-stimulation-mode-and-location-for-auditory-hallucination-neuromodulation-treatment-100279394","NCT02916810","Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment","Inclusion Criteria:\n\n* Male and female ages between ages 18-50 years\n* Ability to give written informed consent (age 18 or above)\n* Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.\n* Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).\n* Have auditory hallucinations despite treated by two or more antipsychotics including one atypical antipsychotic medication.\n* Agrees to: (a) provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and\u002For has provided service to the subject within two years of study enrollment; and (b) provide the names and verifiable contact information (name, email and mailing address, mobile and land-line phone number, as applicable) of at least two reliable persons ≥ age 22, who reside within a 30-minute drive of the subject's residence, and whom the research staff is at liberty to contact, as deemed necessary, for the duration of study participation.\n\nExclusion Criteria:\n\n* Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer \"yes\" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.\n* Taking \\> 400 mg clozapine\u002Fday and not on anti-seizure medication(s) with sufficient dose.\n* Failed TMS screening questionnaire.\n* Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence\n* Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.\n* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.\n* History of head injury with loss of consciousness over 10 minutes; history of brain surgery\n* Cannot refrain from using alcohol and\u002For marijuana 24 hours or more prior to experiments.\n* Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.\n* Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e. answers YES to Question 3 and NO to Question 6 (Moderate risk); or answers YES to Questions 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.\n* In the medical opinion of the investigator, subjects with the following circumstances or conditions which can increase the risk of seizures may be excluded: sleep deprivation; major depressive disorder comorbid with dementia, underweight status; concurrent use of cephalosporins and antiarrhythmics (particularly propranolol); metabolic abnormalities (hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure\u002Furemia, liver failure); raised blood concentrations of proconvulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections); alcohol withdrawal; use of stimulants, such as cocaine or MDMA; use of immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome; dialysis; systemic infection, and fever itself.\n* History (or family history) of deep vein thrombosis.","50 Years",{"count":413,"type":21},140,[63],"The purpose of the study is to test the hypothesis that functionally navigated repetitive TMS stimulations to the prefrontal cortex (PFC) modulate aberrant cortical electrical activities at PFC circuitry. The TMS location of the PFC site will be individually localized by the symptom-related functional connectivity between PFC and symptom related areas (such as the auditory and language processing cortex). The investigators predict that such modulation will correct abnormal activities in patients with schizophrenia, reduce symptoms, especially auditory hallucination, and improve working memory\u002Fsustained attention performance.",[27],[286,132,418],"MRI","2025-07-24",{"date":421,"type":41},"2025-07-28",{"date":423,"type":41},"2025-02-01",{"date":425,"type":21},"2029-07-01",{"name":296,"class":48},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":434,"enrollmentInfo":435,"targetDuration":4,"studyType":61,"phases":436,"briefSummary":437,"conditions":438,"keywords":445,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":84},"100573643","ketogenic-metabolic-therapy-in-schizophrenia-bipolar-disorder-major-depressive-disorder-deep-omic-profiling-100573643","NCT06748950","Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling","A Randomized Controlled Trial of a Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling","Inclusion Criteria:\n\n1. diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and or schizophrenia\n\n   1. For individuals diagnosed with bipolar disorder (BD):\n\n      * Meet DSM V criteria for BD (any subtype)\n      * Not mild\n      * \\>40 on BPRS\n      * clinically stable (with no hospitalization for past 3 months)\n   2. For individuals diagnosed with major depressive disorder (MDD):\n\n      * Not mild\n      * PHQ-9 \\> 10\n      * clinically stable (with no hospitalization for past 3 months)\n   3. For individuals diagnosed with schizophrenia:\n\n      * Meet DSM V criteria for schizophrenia (any subtype)\n      * Not mild\n      * \\>40 on BPRS\n      * clinically stable (with no hospitalization for past 3 months)\n2. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medication. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable. Participants may be switched from other classes of medication to another medication class by their psychiatrist or primary care doctor, but need to be stable enough to enroll and adhere to study procedures.\n3. willing and able to give informed consent for participation in English.\n4. live within the United States.\n\n   \\--------------------------------------------------------------------------------\n\nExclusion Criteria:\n\n1. has started the ketogenic diet or was in ketosis within 3 months of wanting to enroll\n2. pregnant or nursing\n3. insulin dependent\n4. comorbidity of developmental delay\n5. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary programs.\n6. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months\n7. inability to complete baseline measurements\n8. severe renal or hepatic insufficiency\n9. cardiovascular dysfunction, including diagnosis of:\n\n   * Congestive heart failure\n   * Angina\n   * Arrhythmias\n   * Cardiomyopathy\n   * Valvular heart disease\n10. active substance abuse with illicit drugs or alcohol and\u002For current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine or cannabis dependence\n11. active suicidal and considered at significant risk for suicide during course of study\n12. participation in any clinical trial- within the past month or concurrent to study participation- with an investigational drug\u002Fdevice and\u002For intervention that may interfere with study participation\u002Fevaluation of results\n13. mild BPRS at screening or baseline visits\n14. history of TBI\n15. any other medical condition that may make diet intervention dangerous as determined by the study medical team (e.g. anorexia nervosa) or assessed by study team to have insufficient control over their food intake to adhere to study diets.\n16. any medical condition that physicians or the PI believe would interfere with study participation or evaluation of results\n17. history of familial hypercholesterolemia","80 Years",{"count":93,"type":21},[63],"The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.",[159,27,261,439,239,440,441,442,443,444],"Bipolar and Related Disorders","Major Depression Severe","Ketogenic Dieting","Ketosis","Metabolic Disease","Metabolic Syndrome",[446,447,448,449],"Mental Illness","Multiomics","Multi-omics","Omics Profiling","2025-05-13",{"date":452,"type":41},"2025-05-16",{"date":454,"type":21},"2025-07",{"date":456,"type":21},"2028-07",{"name":458,"class":48},"Stanford University",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":208,"maxAge":305,"enrollmentInfo":467,"targetDuration":4,"studyType":61,"phases":469,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":84},"100590212","a-trial-of-extended-reality-activities-to-enhance-leisure-participation-among-inpatients-with-persistent-mental-health-conditions-100590212","NCT06964477","A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions","A Randomized Controlled Trial of an Extended Reality-Based Occupational Therapy Intervention to Improve Leisure Participation in Inpatients With Persistent Mental Health Conditions","XR-MHLP","Inclusion Criteria:\n\n* Adults aged 20 to 65 years\n* Diagnosed with chronic schizophrenia or schizoaffective disorder (ICD-10 F20.x or F25.x)\n* Hospitalized continuously for at least 6 months\n* Clinically stable with no acute psychiatric symptoms\n* Able to walk independently and communicate verbally\n* Mini-Mental State Examination (MMSE) score ≥ 24\n\nExclusion Criteria:\n\n* History of epilepsy, severe motion sickness, or other seizure-related conditions\n* Significant visual or auditory impairments that may interfere with XR experience\n* Physical conditions that limit participation in leisure activities\n* Current diagnosis of substance abuse or major organic brain disorder\n* Inability to distinguish between reality and virtual environments",{"count":468,"type":21},25,[63],"The goal of this clinical trial is to evaluate the effects of an extended reality (XR)-enhanced occupational therapy leisure intervention on motivation, emotional engagement, and therapeutic participation among inpatients with chronic psychiatric conditions. The main questions it aims to answer are:\n\nCan the XR intervention improve leisure motivation, leisure-related attitudes, and emotional coping strategies in long-term hospitalized individuals with mental illness?\n\nDoes the XR intervention promote improvements in psychological health, volition, and occupational performance?\n\nResearchers will compare an XR-based leisure therapy group to a usual care group engaged in standard hospital leisure activities such as art, music, or reading. Participants will take part in weekly 40-minute sessions for 6 weeks. The XR group will use a custom-designed mobile VR program featuring immersive 360° leisure scenarios aligned with participants' interests and functional goals. Data collection includes standardized assessments (e.g., Interest Checklist, Volitional Questionnaire, COPM, PANSS) and semi-structured interviews to explore changes in motivation, coping, and perceived benefits.",[27,472,473],"Mental Disorders","Inpatients",[475,476,477,478,479,480,481,482],"Leisure Activities","Virtual Reality Exposure Therapy","Augmented reality","Extend reality","Schizoaffective Disorder","Volition","Motivation","Emotional Regulation","2025-05-01",{"date":485,"type":41},"2025-05-09",{"date":487,"type":21},"2025-07-01",{"date":489,"type":21},"2025-10-31",{"name":491,"class":48},"Chia-Hui Hung",{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":61,"phases":502,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":84},"100514719","avatar-mediated-therapy-versus-cognitive-behavioural-therapy-for-persisting-experiences-of-hearing-voices-100514719","NCT05982158","Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices","Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial","AMETHYST","Inclusion Criteria:\n\n* Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis confirmed using the Structured Clinical Interview for DSM (SCID)\n* Experiencing current auditory verbal hallucinations as measured by the Positive and Negative Syndrome Scale (PANSS) item P3 ≥ 4\n* Auditory verbal hallucinations present for at least one year\n* AVHs include significant negative content (PSYRATS item 6 ≥ 2) and\u002For AVHs are distressing (PSYRATS item item 9 ≥ 2)\n* Current treatment with antipsychotic medication, or has been treated with antipsychotic medication in the past, with at least two different antipsychotic compounds, and these have been discontinued due to insufficient treatment response and\u002For poor tolerability.\n* Access to the internet and a computer or other device on which videoconferencing software can be used\n* Sufficient fluency in English for meaningful participation\n* Age 18 or over\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Auditory verbal hallucinations attributable to a primary substance use disorder or organic disorder\n* Estimated full scale IQ \\\u003C 70 (using the Test of Premorbid Functioning, TOPF)\n* Within the last month or planned at the time of intake: a change of antipsychotic medication,\n* Current or within the past 3 months receipt of individual psychological therapy for hearing voices, or receipt of electro-convulsive therapy or other brain stimulation treatment;\n* AVHs in a language not spoken by the therapists.",{"count":501,"type":21},212,[63],"The aim of this study is to compare the effects of a new psychological therapy, Avatar Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving outcomes in people living with psychotic disorders who have persisting experiences of hearing voices (auditory verbal hallucinations, AVHs).",[505,25,27],"Auditory Hallucination",[507,26,159,508,509,510,69,511],"Auditory verbal hallucinations","Psychological therapy","Cognitive behavior therapy","Avatar therapy","Telehealth","2024-11-19",{"date":514,"type":41},"2024-11-22",{"date":516,"type":41},"2023-08-08",{"date":518,"type":21},"2027-06",{"name":520,"class":48},"Swinburne University of Technology"]