[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-1-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-1-disorder":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,55,80,116,142,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100600716","socio-cognitive-and-biological-responses-to-maltreatment-100600716",false,"NCT07101107","Socio-cognitive and Biological Responses to Maltreatment","Socio-cognitive and Biological Responses to Childhood Maltreatment in Individuals With Bipolar Disorder and Control Subjects","Inclusion Criteria for individuals diagnosed with bipolar disorder (BD):\n\n* diagnosis of a moderate to severe depressive episode without psychotic features in the context of BD-I according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5: 296.52 BD-I, most recent episode depressed, moderate; 296.53 BD-I, most recent episode depressed, severe without psychotic features;\n* Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20;\n* age between 18 and 65 years; and\n* able to provide written informed consent for magnetic resonance imaging (MRI) and study participation.\n\nExclusion Criteria for individuals diagnosed with BD:\n\n* a history of one or more diagnoses of the following DSM-5 categories: past or current moderate or severe substance dependence (303.x, 304.x, 305.x) with the exclusion of tobacco use disorder (305.1), neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x), schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x), neurocognitive disorders (290.x, 292.x, 294.x, 331.x), BD-I Single Manic (296.0x), BD-I Manic (296.4x), BD-I Mixed (296.6, 296.7, 296.8, 296.9), BD-II (296.89), or comorbid Borderline Personality Disorder (BPD) as assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD);\n* a current episode of illness with psychotic features (296.54);\n* a recent history of central nervous system (CNS) trauma or significant CNS trauma;\n* physical illness that might interfere with the participant's cognitive performance;\n* an autoimmune disorder or inflammatory diseases;\n* currently on anti-inflammatory drugs, cortisol or cortisol derivates;\n* cardiovascular impairment with life-threatening issues;\n* electroconvulsive therapy in the last 12 months;\n* current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen;\n* IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest\" version B (MWT-B);\n* MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or\n* other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires).\n\nInclusion Criteria for healthy volunteers:\n\n* absence of any axis I disorder according to DSM-5 and physical illness that might interfere with participant's cognitive performance;\n* age between 18 and 65 years according to clinical group; and\n* ability to give written informed consent for MRI and study participation.\n\nExclusion Criteria for healthy volunteers:\n\n* first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies;\n* a history of any axis I disorder, neurological, developmental disorders, CNS trauma, or comorbid BPD.\n* physical illness that might interfere with the participants' cognitive performance;\n* an autoimmune disorder or inflammatory diseases;\n* currently on anti-inflammatory drugs, cortisol or cortisol-derivates;\n* cardiovascular impairments with life-threatening issues;\n* current substance abuse;\n* IQ≤70;\n* MRI contraindications; or\n* other ethical considerations.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},160,"ESTIMATED","OBSERVATIONAL","The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism. However, it is unclear how a history of emotional CM affects psychological and biological outcomes in bipolar disorder (BD). Therefore, this study focuses on understanding how a possible history of CM affects BD compared to control participants (CP) with no known psychiatric illness.\n\nThe aim of the project is to investigate how a history of emotional CM is associated with social cognition. The investigators will recruit 80 CP and 80 people diagnosed with BD, some of whom will have a history of CM. The investigators will assess psychological well-being (social behaviour, empathy) at two points in time at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology at the Medical University of Innsbruck (MUI). Additionally, as they want to understand how emotional CM affects brain function and structure, the investigators will perform magnetic resonance imaging (MRI) of the brain at the Neuroimaging Core Facility (Medical University of Innsbruck). The investigators also want to understand how biological markers in the blood (such as telomere length, inflammation) might be affected, assessed in collaboration with the Department of Psychology (Leopold-Franzens University of Innsbruck). Finally, the investigators will look at a combination of the psychological and biological tests to see if there is a link between emotional CM and health outcomes.",[26,27],"Bipolar 1 Disorder","Control Subjects",[29,30,31,32,33,34,35,36,37,38,39,40,41],"childhood maltreatment","Social Cognition","empathy","Bipolar Disorder","Biomolecules","Magnetic Resonance Imaging","Theory Of Mind","telomere length","mitochondria","benevolent childhood experiences","trauma","positive childhood experiences","inflammatory markers","NOT_YET_RECRUITING","2026-06-24",{"date":45,"type":46},"2026-06-29","ACTUAL",{"date":48,"type":22},"2026-07-01",{"date":50,"type":22},"2030-02-28",{"name":52,"class":53},"Medical University Innsbruck","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100644277","phase-4-risperidone-vs-cariprazine-in-acute-mania-100644277","NCT07665073","Risperidone vs Cariprazine in Acute Mania","Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability","RCAM","Inclusion Criteria:\n\npatients with bipolar mania Age 18-60 YMRS\\>20 -\n\nExclusion Criteria:\n\nPatients with substance use Patients already taking antipsychotics Secondary mood disorder\n\n\\-","60 Years",{"count":65,"type":22},50,"INTERVENTIONAL",[68],"PHASE4","Randomized, double-blind, parallel-group study comparing efficacy and safety of Risperidone versus Cariprazine in adults with acute manic episodes. Participants will receive oral study drug for 6 weeks. Primary outcome is change in YMRS total score from baseline to week 6.",[26],"2026-06-18",{"date":43,"type":46},{"date":74,"type":22},"2027-06",{"date":76,"type":22},"2028-06",{"name":78,"class":79},"Pakistan Institute of Medical Sciences","OTHER_GOV",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":87,"targetDuration":4,"studyType":66,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100596517","phase-2-study-evaluating-the-efficacy-and-safety-of-rap-219-in-adult-participants-with-bipolar-i-disorder-100596517","NCT07046494","Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder","A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder","Inclusion Criteria:\n\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without psychotic symptoms, as confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT). Episode may contain mixed features, as confirmed by Montgomery-Åsberg Depression Rating Scale (MADRS).\n* Had at least one prior documented manic episode (with or without psychotic symptoms) that required treatment, within 5 years prior to Visit 1\n\nExclusion Criteria:\n\n* History of any of the following diagnoses: a. schizophrenia; schizoaffective disorder; major depressive disorder; moderate or severe substance or alcohol use disorder; as assessed by the SCID-5-CT b. delirium, dementia, amnestic, or other cognitive disorders; borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders; by medical history and\u002For Investigator opinion Note: Any other current diagnoses must be discussed with the Medical Monitor.\n* Rapid cycler, defined as experiencing ≥4 distinct mood episodes (ie, manic or depressive) each meeting full DSM-5 criteria in the previous 12 months, and each separated by ≥2 months of full or partial remission, or a switch to an episode of the opposite polarity, as assessed by the SCID-5-CT",{"count":88,"type":22},250,[90],"PHASE2","This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.",[26],[94,95,96,97,98,99,100,101,102,103],"Bipolar","Mania","Acute","In-patient","Manic State","Manic Episode","Mixed Features","Episode with Mixed Features","Mixed Mania","Bipolar Episode","RECRUITING","2026-06-17",{"date":107,"type":46},"2026-06-22",{"date":109,"type":46},"2025-07-25",{"date":111,"type":22},"2026-11",{"name":113,"class":114},"Rapport Therapeutics Inc.","INDUSTRY",22,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":123,"targetDuration":4,"studyType":66,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100407031","phase-4-clozapine-response-in-biotype-1-100407031","NCT04580134","CLOZAPINE Response in Biotype-1","Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)","Inclusion Criteria:\n\n* 18-60y\u002Fo; males and females; all races and ethnicities; able to provide written informed consent; able to read, speak, and understand English; medically stable; meeting DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features (we will use DSM-IV to be consistent with prior B-SNIP samples); PANSS total score of ≥70 and at least one item scored ≥5 or two items scored ≥4 on PANSS Positive Subscale; normal baseline values for absolute neutrophil count (ANC above 1500\u002Fmm3)\n\nExclusion Criteria:\n\n* premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest, age-corrected standardized score); comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months; neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovascular disorder, AIDS) that may affect central nervous system function; concomitant medications known to affect EEG properties (i.e., lithium, anticonvulsants, benzodiazepines) or strong CYP 1A2 inhibitors (e.g., ciprofloxacin, enoxacin) or strong CYP 3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital, rifampin) which cannot be safely discontinued; vulnerable populations (e.g., pregnant, nursing, incarcerated); unwilling to use reliable means of contraception; history of neuroleptic malignant syndrome; prior treatment with clozapine, prior treatment with long-acting injectable antipsychotics that are 1-month formulations within the past 3 months and for 3-month formulations within the past 6 months; intolerable side effects to either clozapine or risperidone in lifetime, or a previously failed trial of either clozapine or risperidone at adequate doses in lifetime; history of drug reaction with eosinophilia and systemic symptoms syndrome (DRESS), also known as drug-induced hypersensitivity syndrome (DIHS); high risk for suicide defined as more than 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded; current homicidal ideation with plan and intent such that outpatient care is precluded.",{"count":124,"type":22},524,[68],"The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \\~50% each) in order to enroll n=320 (B1 and B2) into the RCT.",[128,129,26],"Schizophrenia","Schizoaffective Disorder",[131],"Schizophrenia, Bipolar, Psychosis, Biomarker, Biotype, BSNIP, B-SNIP, IEA","2026-05-07",{"date":134,"type":46},"2026-05-11",{"date":136,"type":46},"2022-03-01",{"date":138,"type":22},"2027-04-30",{"name":140,"class":53},"University of Texas Southwestern Medical Center",5,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":5},"100572985","biomarkersbiotypes-course-of-early-psychosis-and-specialty-services-100572985","NCT06740383","Biomarkers\u002FBiotypes, Course of Early Psychosis and Specialty Services","BICEPS","Inclusion Criteria:\n\n* Males and females, all races and ethnicities\n* 18-40 y\u002Fo\n* Meet DSM-5 criteria for a psychotic disorder, i.e. schizophrenia, schizophreniform, schizoaffective disorder, or bipolar I disorder or major depression with psychotic features, delusional disorder or psychosis N.O.S.\n* Able to read, speak, and understand English\n* Able and willing to provide written informed consent, and willing to commit to the study protocol\n* Illness duration from psychosis onset less than or equal to 4 years\n* At baseline only: receiving both psychopharmacology and psychotherapy\n\nExclusion Criteria:\n\n* Estimated premorbid intellectual ability \\\u003C70 (WRAT-4, Word Reading subtest, age-corrected standardized score)\n* Neurological or medical disorder that may affect brain function (seizure disorder, traumatic brain injury with a loss of consciousness greater than or equal to 30 min, history of stroke, AIDS, etc.)\n* Psychoses secondary to substance use i.e., Comorbid DSM-5 diagnosis of alcohol or substance use disorders that may explain the diagnosis of psychotic disorders (individuals with cannabis use disorders unrelated to psychosis onset will be allowed. Participants encouraged to abstain from substances for 24 hours prior to lab visits)\n\nMRI-Specific Exclusion Criteria:\n\n* Pregnant women\n* Presence of ferromagnetic objects in body\n* Weight or body size exceeding scanner capacity (\\>300 lbs)\n* Claustrophobia","40 Years",{"count":151,"type":22},320,"The Biomarkers\u002FBiotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.",[154,128,155,26,129,156,157],"Schizophrenia Spectrum and Other Psychotic Disorders","Delusional Disorder","Psychosis Not Otherwise Specified","Early Psychosis",[159,160,161,162,163,164,165,166,167,168],"schizophrenia","bipolar disorder","schizoaffective disorder","schizophreniform","major depression","psychosis","delusional disorder","Biotypes","Biomarkers","coordinated specialty care","2026-03-06",{"date":171,"type":46},"2026-03-10",{"date":173,"type":46},"2023-01-01",{"date":175,"type":22},"2027-06-30",{"name":177,"class":53},"Beth Israel Deaconess Medical Center",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":66,"phases":187,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":54},"100607878","feasibility-and-preliminary-results-of-the-efficacy-of-blue-blocking-glasses-on-manic-symptoms-in-bipolar-disorder-100607878","NCT07194278","Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder","B2Bi","Inclusion Criteria:\n\n* Patient over 18 years old\n* Patient with a type 1 bipolar disorder presenting a manic episode according to the DSM-5 TR, with or without associated psychotic disorders.\n\nExclusion Criteria:\n\n* Patient who did not agree to participate to the study\n* Patient unable to be informed or understand the course of the study\n* Patient with severe eye problem or with an history of trauma affecting the eyes\n* Pregnant or breastfeeding women\n* Patient in need of urgent care",{"count":186,"type":22},25,[188],"NA","The goal of this clinical trial is to assess the feasibility of conducting a clinical trial of the use of blue-blocking glasses among patients with a type1 bipolar disorder, experiencing a manic episode. The feasibility criteria include: recruitment rates, participation rates, adherence to the research protocol, the material feasibility of the study. Feasibility criteria will be assessed at the end of the study period.\n\nThe investigators also want to assess patients' acceptability regarding the use of blue-blocking glasses during a manic episode, using self-reported satisfaction criteria. Those criteria will be monitored at the end of participation period for each patient (7 days after inclusion).\n\nIn addition, the study will evaluate the impact of the use of blue-blocking glasses on the severity of manic symptoms, sleeping pattern (quality of sleep, sleep latency, night wake, etc.), global functioning, and on suicidal ideations. Those indicators will be assessed at day 0 (inclusion), day 3 and day 7, using validated questionnaires and actimetry data.\n\nThe study is presented to all patients over 18 years old, with type 1 bipolar disorder, presenting a manic episode, hospitalised in an adult psychiatric ward of Bichat Hospital (GHU Paris).\n\nPatients' participation duration is of 7 days after inclusion.",[26],[192,193,194],"bipolar 1 disorder","blue-blocking glasses","manic episode","2025-09-18",{"date":197,"type":46},"2025-09-26",{"date":199,"type":46},"2024-07-19",{"date":201,"type":22},"2026-09-01",{"name":203,"class":53},"Centre Hospitalier St Anne"]