[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-affective-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-affective-disorder":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,56,87,118,145,173,203,236],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100623571","medical-phenotyping-of-nhs-general-adult-psychiatry-gap-inpatients-100623571",false,"NCT07398365","Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients","Inclusion:\n\n\\- Adults aged between 18 and 65 years admitted to GAP wards during recruitment period\n\nExclusion:\n\n\\- Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)","ALL","18 Years","65 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) \"mental health\" inpatient wards, providing the first detailed information on morbidity in this patient population.",[24,25,26,27],"Bipolar Affective Disorder","Schizophrenia Disorders","Depression Disorders","Personality Disorders",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"General Adult Psychiatry","mental health","physical health","inpatients","schizophrenia","NHS","Bipolar affective disorder","depression","psychosis","treatment resistance","personality disorder","cardiometabolic disease","cancer","respiratory disease","RECRUITING","2026-06-30",{"date":46,"type":47},"2026-07-01","ACTUAL",{"date":49,"type":47},"2024-04-03",{"date":51,"type":20},"2026-12-31",{"name":53,"class":54},"University of Edinburgh","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":55},"100629238","phase-2-melatonin-versus-placebo-for-bipolar-disorder-100629238","NCT07472075","Melatonin Versus Placebo for Bipolar Disorder","Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial","M-bipolar RCT","Inclusion Criteria:\n\n* Bipolar disorder with diagnosis confirmed by SCAN interview\n* Age 18 - 70 years\n* The participants must be able to read and understand the participant information in their native language and consent (English and Danish)\n* Habile (i.e able to give informed consent)\n\nExclusion Criteria:\n\n* Past intolerance to melatonin (allergic reactions)\n* Impaired renal or hepatic function (defined by GFR \\\u003C60 ml\u002Fmin and\u002For ALAT over allowed reference value)\n* Women who are pregnant, breastfeeding or planning pregnancy in near future.","70 Years",{"count":66,"type":20},200,"INTERVENTIONAL",[69],"PHASE2","The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and\u002For prophylactic against relapse",[24],[73,74,75,76,77],"Melatonin","Bipolar disorder","Mental disorders","Bipolar and related disorders","Mood disorder","2026-05-07",{"date":80,"type":47},"2026-05-12",{"date":82,"type":47},"2026-05-08",{"date":84,"type":20},"2028-06",{"name":86,"class":54},"Lars Vedel Kessing",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":15,"minAge":16,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":116,"locationsCount":55},"100573240","validation-and-impact-of-cardiorespiratory-fitness-in-severe-mental-illness---the-heart-in-mind-project-100573240","NCT06743711","Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project","Inclusion Criteria:\n\n* 18-45 years\n* Diagnosis within schizophrenia spectrum or affective disorders (i.e. F2.x or F3.x according to ICD-10 classification)\n* current antipsychotic treatment for more than one month on a regular daily dose\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of uncompensated medical disease\n* Unstable psychiatric disorder\n* Acute suicidal risk\n* Planned hospitalization within the study period.",true,"45 Years",{"count":96,"type":20},75,"This project aims to evaluate feasibility, validity and clinically applicability to systematically measure fitness in patients with severe mental illness.\n\nThe research project is a validation study using a cross-sectional design. The project will include 50 people with severe mental illness and 25 healthy controls without present or previous mental illness. The protocol includes a baseline visit where three different ways of measure fitness will be carried out, and a 14-day period of physical activity monitoring.",[99,100,24],"Severe Mental Illness","Schizophrenia Spectrum &Amp; Other Psychotic Disorders",[102,103,104,105,106,107,108,109],"cardiorespiratory fitness","severe mental illness","cardiovascular disease","validation","physical activity","cardiopulmonary exercise test","non-exercise vo2max estimation","vo2max","2026-04-28",{"date":112,"type":47},"2026-05-04",{"date":114,"type":47},"2025-01-01",{"date":44,"type":20},{"name":117,"class":54},"Bjorn H. Ebdrup",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":125,"targetDuration":4,"studyType":67,"phases":127,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":55},"100624630","phase-3-evaluation-of-the-efficacy-safety-and-tolerability-of-lacosamide-in-major-depressive-episodes-of-bipolar-disorder-types-i-and-ii-100624630","NCT07412132","Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.","Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.","Inclusion Criteria:\n\n1. Diagnosis of bipolar disorder (type I or II) confirmed by structured clinical interview;\n2. acute major depressive episode of moderate or severe intensity;\n3. no response to at least two adequate pharmacological interventions to treat the current episode.\n\nExclusion Criteria:\n\n1. Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance use disorders, eating disorders, and attention deficit disorder) will be permitted provided the primary diagnosis is bipolar disorder;\n2. acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);\n3. current depressive episode with psychotic features (by clinical assessment);\n4. suspected or confirmed pregnancy;\n5. severe or unstable clinical illnesses;\n6. previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;\n7. previous history of non-response to an adequate course of ketamine treatment.",{"count":126,"type":20},40,[128],"PHASE3","Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot study, comparing the enhancement of the treatment that patients had been using with lacosamide and placebo, over a duration of 12 weeks. Forty subjects aged between 18 and 65 years with a diagnosis of BD (I or II) in a moderate or severe major depressive episode, despite the use of first- or second-line treatments, will be selected. The primary outcome will be the assessment of lacosamide efficacy through the difference in scores on the Hamilton Depression Rating Scale (HAMD-17) from the initial visit to the end of week 12 of intervention between the lacosamide and placebo groups.",[24],[132,133,134,135],"lacosamide","randomized clinical trial","bipolar disorder","bipolar depression","2026-02-18",{"date":138,"type":47},"2026-02-20",{"date":140,"type":47},"2026-01-09",{"date":142,"type":20},"2027-01",{"name":144,"class":54},"University of Sao Paulo",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":67,"phases":155,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":171,"locationsCount":55},"100579987","effectiveness-of-digital-cognitive-behavioral-therapy-for-the-treatment-of-depression-a-real-world-study-100579987","NCT06831435","Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study","Inclusion Criteria:\n\n1. Aged 14-60 years (including 14 and 60), no gender restriction;\n2. HAMD \\>= 14;\n3. Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.\n\nExclusion Criteria:\n\n* Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).","14 Years","60 Years",{"count":154,"type":20},325,[156],"NA","The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.",[159,24,160,161],"Depression","Schizophenia Disorder","Psychiatric &Amp;or Mood Disorder",[163,164],"i-CBT","a real-world study","2025-12-08",{"date":167,"type":47},"2025-12-15",{"date":169,"type":47},"2024-11-13",{"date":51,"type":20},{"name":172,"class":54},"Peking University",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":179,"targetDuration":4,"studyType":67,"phases":181,"briefSummary":182,"conditions":183,"keywords":190,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":201,"locationsCount":55},"100585570","prediction-and-intervention-effect-of-rehabilitation-status-for-severe-mental-disorder-patients-based-on-multimodal-analysis-and-ai-agents-100585570","NCT06904079","Prediction and Intervention Effect of Rehabilitation Status for Severe Mental Disorder Patients Based on Multimodal Analysis and AI Agents","Inclusion criteria:\n\n* Registered in the Shanghai Mental Health Information Management System,\n\n  * Diagnosed patients with one of the six severe mental disorders: schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder, mental disorder due to epilepsy, and mental retardation accompanied by mental disorder,\n\n    * Aged between 18 and 65 years old, ④ Normal vision or hearing, or within the normal range after correction, ⑤ Patients or their families have provided informed consent for this study and signed the informed consent form.\n\nExclusion criteria:\n\nPatients with severe physical illnesses or organic brain diseases.",{"count":180,"type":20},82,[156],"Mental health issues represent a major public health and social problem that significantly impacts economic and social development. Compared to other diseases, mental disorders can impair various aspects of a patient' s life, including psychological, social, occupational, and educational functions, affecting their quality of life and daily living abilities. Particularly, severe mental disorders tend to have a chronic course, often resulting in diminished social functions and social withdrawal, making it difficult for patients to integrate into society. Repeated, systematic, and comprehensive rehabilitation training for patients with severe mental disorders can effectively control or delay disease recurrence, improve social functions, enhance quality of life, and facilitate patients' reintegration into society.\n\nIn recent years, the scope of mental disorder rehabilitation has expanded to include enhancing patients' social functions and promoting their integration into society. Vocational rehabilitation and social skills training are widely used in the rehabilitation treatment of patients with severe mental disorders, and some physical intervention methods, such as neurofeedback training, have also proven to be significantly effective in the rehabilitation process. However, traditional rehabilitation techniques often lack specificity and fail to meet individualized needs of patients. Additionally, the rehabilitation process lacks long-term monitoring, making it challenging to continuously assess and adjust patients' rehabilitation outcomes. Furthermore, the assessment of rehabilitation effectiveness mainly relies on patients' subjective feelings and clinical observations, lacking high-quality evidence. Therefore, there is an urgent need to introduce new rehabilitation technologies and scientifically evaluate their effectiveness to address the shortcomings of traditional methods and provide more personalized, precise, and effective rehabilitation support.\n\nWith the rise of digital health technologies, the field of mental health rehabilitation has encountered new opportunities. Compared to traditional therapies, digital health is revolutionizing the healthcare industry, moving away from traditional approaches to healthcare management to real-time personalized monitoring and therapeutic care.Technologies such as remote monitoring, virtual reality, and computer-assisted cognitive correction therapy are increasingly applied in rehabilitation. However, these methods still need improvements in data management and integration capabilities. A large amount of data accumulates in systems, recording only the training process and real-time effects of patients, without further evaluating their rehabilitation status, leading to resource waste. Therefore, there is an urgent need to develop a digital rehabilitation model that better meets the genuine needs of patients with severe mental disorders.\n\nThis study aims to integrate multimodal technology, reinforcement learning, and agent-based modeling (ABM) into the research of mental health rehabilitation to more accurately assess and predict the rehabilitation status of mental disorder patients and to more effectively guide and support decision-making in mental rehabilitation treatment.",[184,185,186,187,24,188,189],"Severe Mental Disorder","Schizophrenia","Schizoaffective Disorder","Paranoid Psychosis","Mental Disorders Due to Epilepsy","Mental Retardation Accompanied by Mental Disorders",[184,191,192,193,194],"Reinforcement Learning","Agent-based Modeling","Multimodal and Crossmodal AI framework","Digital rehabilitation","2025-08-12",{"date":197,"type":47},"2025-08-17",{"date":199,"type":47},"2024-03-12",{"date":44,"type":20},{"name":202,"class":54},"Shanghai Mental Health Center",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":93,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":55},"100591287","dialog-understanding-disorganisation-a-language-focused-global-initiative-in-psychosis-100591287","NCT06978465","DIALOG: Understanding Disorganisation: A Language-focused Global Initiative in Psychosis","DIALOG","Inclusion Criteria:\n\n\\- English or French speaking participants, male or female; age 18-65 years. Patients who have been previously diagnosed by their treating physician based on the Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM 5) criteria for schizophrenia or schizoaffective disorder. Ethnically and socioeconomically diverse individuals from urban catchments. Women are under-represented in psychosis studies but across sexes disorganisation is equally severe. We aim for \\>40% women in our samples via broader inclusion criteria not limited to schizophrenia.\n\nHealthy Controls group-matched with the patients for age (within 2 years), and sex matched to patient sample; and have no personal or first-degree family history of Severe Mental Disorders (SMD).\n\nExclusion Criteria:\n\nPregnancy; substance-induced psychosis with no SMD; neurological speech or auditory impairment, contraindication for MRI; Not able to give informed consent (if this is in doubt at the time of referral, we will formally test it). Not be able to speak French or English for clinical interactions; participants who are not proficient will be excluded.",{"count":211,"type":20},150,"Disorganized speech, language and communication, also called 'formal thought disorder,' is a key part of severe mental illnesses like psychosis and mood disorders. When someone's communication is disorganized, it makes social interactions difficult, increases stigma and affect educational and employment opportunities. However, we do not know much about why this happens. This project, called DIALOG, aims to understand the brain's role in disorganization by studying everyday language use instead of traditional clinical ratings. The study will look at how our brain creates predictions during interactions and how these processes break down in psychosis. This international project also includes experts with personal experience of mental illness. The study will look at speech, thinking patterns, symptoms, and brain waves. The goal of the study is to see if brain waves are disrupted in psychosis, especially in language-related problems. Speech tasks, like describing pictures, talking about a significant event, and telling a story are administered. These tasks will be audio-recorded for analysis. Non-invasive brain imaging technologies such as Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) are utilized. MRI creates images of the brain's structure, while MEG records magnetic activity from neurons, shown as brain waves. The MRI machine uses a large magnet to create images, and MEG captures small magnetic field changes from brain activity. Participants will also undergo clinical and neurocognitive assessments. The study will combine Large Language Models (LLM) applied to speech recordings with large scale participant data from neuroimaging tools (MRI\u002FMEG). The goal of DIALOG is to pioneer a computationally informed, molecular-to systems-level account of disorganisation, identifying the precise mechanisms that can be targeted with novel treatments. This project aims to gather speech and neuroimaging data from Montreal \\[100 healthy volunteers and 50 patients with psychosis\\], Groningen \\[17 synaptic density PET scans\\], Cardiff \\[600 participants\\] and Marburg \\[1600 participants\\] with schizophrenia, schizoaffective disorder or mood disorders and user acceptability data at Pavia and Melbourne.",[214,25,24,215],"Psychosis","Depressive Disorder",[217,218,219,220,221,222,223,224,225],"disorganization","MEG","language disorder","neural activity","MRI","formal thought disorder","large language models","natural language processing","psycholinguistics","NOT_YET_RECRUITING","2025-05-11",{"date":229,"type":47},"2025-05-18",{"date":231,"type":20},"2025-05-19",{"date":233,"type":20},"2030-04-30",{"name":235,"class":54},"Douglas Mental Health University Institute",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":55},"100566611","a-study-on-the-preference-of-risperidone-dosage-forms-100566611","NCT06657430","A Study on the Preference of Risperidone Dosage Forms","Inclusion Criteria:\n\n* Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.\n\nExclusion Criteria:\n\n* Have difficulty reading and understanding Chinese or refuse to participate in the study.",{"count":243,"type":20},1000,"This study aimed to understand patients' needs and preferences for antipsychotic dosage forms.",[185,24,246,247,248],"Autism Spectrum Disorder","Conduct Disorder","Mental Retardation",[250,251,252,253],"risperidone","patch","cross-sectional study","preference","2024-10-23",{"date":256,"type":47},"2024-10-24",{"date":258,"type":47},"2024-09-19",{"date":260,"type":20},"2025-02-28",{"name":202,"class":54}]