[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-ii":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,73,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100645203","type-d-personality-and-life-satisfaction-in-bipolar-disorder-type-2-and-major-depressive-disorder-100645203",false,"NCT07679204","Type D Personality and Life Satisfaction in Bipolar Disorder Type 2 and Major Depressive Disorder","Examination of Type D Personality and Factors Associated With Life Satisfaction in Parents of Patients Diagnosed With Bipolar Disorder Type 2 and Major Depressive Disorder","1. For Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Inclusion Criteria:\n   * Diagnosis of BD-II according to DSM-5-TR\n   * Remission period\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Exclusion Criteria:\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Primary psychiatric disorders other than BD-II and not in remission for BD-II\n   * Alcohol\u002Fdrug\u002Fsubstance use\n2. For Major Depressive Disorder (MDD) Group:\n\n   \\*Inclusion Criteria:\n   * Diagnosis of MDD according to DSM-5-TR\n   * Remission period\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Major Depressive Disorder (MDD) Group:\n   * Exclusion Criteria:\n\n     * Hypertension\n     * Diabetes mellitus\n     * Chronic kidney disease\n     * Rheumatoid arthritis\n     * Systemic lupus erythematosus\n     * Cardiac illness\n     * Severe neurological disorders\n     * Immunological or systemic illness\n     * Primary psychiatric disorders other than MDD and not in remission for MDD\n     * Alcohol\u002Fdrug\u002Fsubstance use\n3. For Healthy Control (HC) Group:\n\n   \\*Inclusion Criteria:\n   * No psychiatric diagnosis\n   * No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Control (HC) Group:\n\n   \\*Exclusion Criteria:\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use\n4. For Healthy Father and\u002For Mother of Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Inclusion Criteria:\n   * No psychiatric diagnosis\n   * No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Father and\u002For Mother of Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Exclusion Criteria:\n\n   • Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use\n5. For Healthy Father and\u002For Mother of Major Depressive Disorder (MDD) Group:\n\n   \\*Inclusion Criteria:\n   * No psychiatric diagnosis\n   * No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Father and\u002For Mother of Major Depressive Disorder (MDD) Group:\n\n   \\*Exclusion Criteria:\n\n   • Hypertension\n\n   • Diabetes mellitus\n\n   • Chronic kidney disease\n\n   • Rheumatoid arthritis\n\n   • Systemic lupus erythematosus\n\n   • Cardiac illness\n\n   • Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use\n6. For Healthy Father and\u002For Mother of Healthy Control (HC) Group:\n\n   \\*Inclusion Criteria:\n\n   • No psychiatric diagnosis\n\n   • No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Father and\u002For Mother of Healthy Control (HC) Group:\n\n   \\*Exclusion Criteria:\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use",true,"ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","OBSERVATIONAL","Bipolar Disorder Type II (BD-II) and Major Depressive Disorder (MDD) are common mood disorders associated with substantial psychological distress, impaired functioning, and reduced quality of life. BD-II is characterized by recurrent major depressive episodes and hypomanic episodes, whereas MDD is characterized by one or more major depressive episodes without a history of mania or hypomania. Both disorders have a significant genetic component, and family studies suggest that first-degree relatives may exhibit subclinical affective traits, personality characteristics, and psychosocial vulnerabilities related to these conditions. The aim of this cross-sectional study was to examine Type D personality traits and life satisfaction among patients with BD-II and MDD and parents of patients. The study recruited\u002Fwill recruit 30 patients with BD-II; 30 patients with MDD; 30 healthy control subjects; mothers and\u002For fathers of 30 healthy control subjects, mothers and\u002For fathers of 30 patients with BD-II, and mothers and\u002For fathers of 30 patients with MDD who are in remission and receiving follow-up care at the Psychiatry Outpatient Clinic of Elazığ Fethi Sekin City Hospital, Turkey (By Dilek ÖRÜM -Associate Professor of Psychiatry, dr.dilekulukan@gmail.com). Sociodemographic characteristics, Type D personality traits, general psychiatric symptoms, and life satisfaction assessed\u002Fwill be assessed using validated self-report measures, including the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS).\n\nThe primary objective was\u002Fis to compare Type D personality characteristics and life satisfaction levels between patients with MDD and BD-II and between their parents. Secondary objectives included\u002Finclude investigating the associations between Type D personality traits, psychiatric symptom severity, and life satisfaction. The findings may contribute to a better understanding of familial psychological characteristics associated with mood disorders and may help identify potential psychosocial targets for preventive and supportive interventions among family members of affected individuals.",[25,26],"Bipolar Disorder II","Major Depressive Disorder (MDD)",[28,29,30,31],"Bipolar disorder type II","Major depressive disorder","Life satisfaction","Type D personality","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2024-12-23",{"date":40,"type":21},"2026-12-24",{"name":42,"class":43},"Elazığ Mental Health and Diseases Hospital","OTHER_GOV",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100641596","phase-2-efficacy-and-mechanism-of-ipsrt-for-bipolar-ii-disorder-100641596","NCT07654348","Efficacy and Mechanism of IPSRT for Bipolar II Disorder","The Efficacy and Mechanism of Different Intervention Strategy for Bipolar II Disorder Patients With Rhythm Disturbance","Inclusion Criteria:\n\n* 1: a primary diagnosis of bipolar II disorder in accordance with DSM-V criteria, in a current major depressive episode;\n\n  2: scoring ≥17 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)\n\n  3: scoring \\\u003C12 on the Young Mania Rating Scale (YMRS)\n\n  4: medication-free (≥4 weeks without psychotropics)\n\n  5: with rhythm disturbance, scoring \\>26 on the Biological Rhythm Interview for Neuropsychiatry (BRIAN)\n\n  6: Understand written language and be able to conduct questionnaire survey\n\n  7: 18 to 60 years old, gender is not limited\n\n  8: the patient voluntarily participates, signs a written informed consent form, is willing to participate in the study and undergo evaluation\n\n  9: Han Chinese\n\n  10: Right-handedness\n\nExclusion Criteria:\n\n* 1: diseases that may significantly increase research risks or interfere with the evaluation of results\n\n  2: patients with rapid-cycling bipolar disorder (with \\>4 episodes within the past year);\n\n  3: any psychiatric or organic mental disorder, bipolar I disorder (BD I), current alcohol or drug dependence, borderline or antisocial personality disorder\n\n  4: patients currently receiving any psychological treatment or melatonin treatment intervention\n\n  5: patients with active suicidal ideation, HAMD-17 item 3 score ≥3\n\n  6: pregnant\n\n  7: patients with metal objects in the body (pacemaker, cochlear implant, implanted teeth, braces, metal foreign bodies, cardiac stent\u002Fintravascular coil, orthopedic steel plate, etc.) and other MRI examination contraindications (claustrophobia or inability to cooperate with the examination).","60 Years",{"count":54,"type":21},216,"INTERVENTIONAL",[57],"PHASE2","This project is based on the biphasic instability model and social timing theory, utilizing IPSRT to help regulate social interactions and establish regular daily habits, alleviate emotional symptoms, and prevent. The included patients with bipolar II disorder who did not take medication for the first time or relapsed within the past month were randomly divided into a medication only group (Q group), a only IPSRT group (I group). Group Q received treatment with quetiapine alone (starting at 50mg\u002Fday, with an additional 50mg to 300mg\u002Fday per week, and the dosage can be flexibly adjusted); Group I received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting). Compare the changes in various clinical evaluation scales and skin potential before and after treatment, explore the safety and effectiveness of drug therapy and psychotherapy for patients with bipolar II disorder with rhythm disorders, and investigate the potential biological mechanism of IPSRT by collecting data on salivary cortisol and melatonin, peripheral circadian rhythm genes (PER1\u002FPER2\u002FPER3\u002FBMAL1), and magnetic resonance.",[25],[61,62],"bipolar disorder II","interpersonal and social rhythm therapy","NOT_YET_RECRUITING","2026-06-12",{"date":66,"type":36},"2026-06-17",{"date":35,"type":21},{"date":69,"type":21},"2029-07-01",{"name":71,"class":72},"First Affiliated Hospital of Zhejiang University","OTHER",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":55,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100441227","phase-1-determining-efficacy-and-safety-of-bxcl501-in-agitation-associated-with-pediatric-schizophrenia-and-bipolar-disorder-100441227","NCT05025605","Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder","Inclusion Criteria:\n\n1. Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).\n2. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).\n3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.\n4. Participants who agree to use a medically acceptable and effective birth control method\n\nExclusion Criteria:\n\n1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.\n2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.\n3. Patients who are judged to be at significant risk of suicide.\n4. Patients with serious or unstable medical illnesses.\n5. Patients who have received an investigational drug within 30 days prior to the current agitation episode.\n6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.","10 Years","17 Years",{"count":83,"type":21},140,[85],"PHASE1","This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.",[88,89,90,91,25],"Schizophrenia","Schizo-Affective Disorder","Schizophreniform; Schizophrenic","Bipolar Disorder I","2026-04-07",{"date":94,"type":36},"2026-04-13",{"date":96,"type":36},"2021-08-27",{"date":98,"type":21},"2027-12-31",{"name":100,"class":101},"BioXcel Therapeutics Inc","INDUSTRY",5,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":44},"100511056","biocollection-on-peripheral-inflammation-100511056","NCT05934474","Biocollection on Peripheral Inflammation","Biocollection on Peripheral Inflammation in Psychiatric Pathologies","IBIS-PSY","Inclusion Criteria:\n\n* Major patient\n* Patient with one of the following diagnoses confirmed by a psychiatrist:\n\n  * Characterized depressive episode with psychotic features,\n  * Bipolar disorder type I\n  * Bipolar disorder type II\n  * Schizoaffective disorder\n  * Schizophrenia\n  * Schizophreniform disorder\n* Patient under psychiatric care at Nantes University Hospital\n* Patients weighing at least 45kg\n* Patient affiliated to a social security scheme or beneficiary of such a scheme\n* Patient who has given informed consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnant,\n* History of cancer in the last 5 years,\n* Vaccination within the last 4 weeks,\n* Acute or chronic infection,\n* Medical history of organ transplant,\n* Medical history of autoimmune disease,\n* Hearing impairment making it impossible to complete study questionnaires,\n* Patient under court protection",{"count":112,"type":21},300,"Most psychiatric research is based on the nosographic classifications used in current practice. At present, there is no diagnostic or prognostic biomarker for psychiatric pathologies commonly used in clinical practice. The study hypothesis is that peripheral inflammatory biomarkers could be common to several psychiatric disorders, in particular psychotic disorders (bipolar disorder, schizophreniform disorder, schizophrenia, depressive episode with psychotic features). The aim of this project is to set up a bio-collection of biological samples (peripheral blood samples) with associated phenotypic data (assessment of various symptoms using standardized scales in patients whose blood is sampled). The setting up of this cohort follows on from work carried out on a PsyCourse cohort also using a transdiagnostic approach in psychiatry, in order to be able to collaborate within a European research project.",[115,91,25],"Schizoaffective Disorder, Depressive Type","2024-04-05",{"date":118,"type":36},"2024-04-08",{"date":120,"type":36},"2024-03-19",{"date":122,"type":21},"2028-02-02",{"name":124,"class":72},"Nantes University Hospital"]