[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-i":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,72,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100441227","phase-1-determining-efficacy-and-safety-of-bxcl501-in-agitation-associated-with-pediatric-schizophrenia-and-bipolar-disorder-100441227",false,"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.","ALL","10 Years","17 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"Schizophrenia","Schizo-Affective Disorder","Schizophreniform; Schizophrenic","Bipolar Disorder I","Bipolar Disorder II","RECRUITING","2026-04-07",{"date":35,"type":36},"2026-04-13","ACTUAL",{"date":38,"type":36},"2021-08-27",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"BioXcel Therapeutics Inc","INDUSTRY",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100524364","cerebellar-modulation-of-cognition-in-psychosis-100524364","NCT06107764","Cerebellar Modulation of Cognition in Psychosis","Inclusion Criteria:\n\n* Age between 18-55 years\n* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month\n* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:\n\n  * Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;\n  * History of fainting spells of unknown or undetermined etiology that might constitute seizures\n  * History of multiple seizures or diagnosis of epilepsy\n  * Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n  * Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n  * Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or transcutaneous electric nerve stimulation unit\n  * Ventriculo-peritoneal shunt\n  * Signs of increased intracranial pressure\n  * Intracranial lesion\n  * History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n  * Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.","18 Years","55 Years",{"count":54,"type":21},95,[56],"NA","The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).\n\nParticipants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.",[27,59,30,60],"Schizoaffective Disorder","Psychosis","2026-03-16",{"date":63,"type":36},"2026-03-17",{"date":65,"type":36},"2024-07-31",{"date":67,"type":21},"2029-12",{"name":69,"class":70},"Mclean Hospital","OTHER",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100506772","melatonin-and-response-to-lithium-100506772","NCT05878730","Melatonin and Response to Lithium","A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.","MeLiR","Inclusion Criteria:\n\n* BD-1 as defined by DSM-5\n* Age : 18 to 70\n* Current treatment by lithium for more than one year\n* Euthymia defined by : MADRS \\\u003C8 and YMRS \\\u003C8 at inclusion ; no hospitalization or change in mood-stabilizing treatment in the previous 3 months\n* Health condition compatible with blood and urinal sampling\n* Being affiliated to french social security\n* Written consent\n\nExclusion Criteria:\n\n* Treatment by : melatonin, agomelatin, benzodiazepines or hypnotic in the last 15 days\n* Treatment by a strong CYP1A2 inducer in the last month : ciprofloxacine, dihydralazine, fluvoxamine, norfloxacine\n* Current substance use disorder except for tobacco\n* Chronic renal failure with glomerular filtration rate \\\u003C60mL\u002Fmin\n* Jetlag in the last 15 days or life-event impacting circadian rhythmicity (birth, grief, night-work...)\n* Sleep disorders such as Obstructive Sleep-Apnea, restless leg syndrome, narcolepsy\n* Pregnancy, breastfeeding\n* Guardianship\n* Inability to understand french, illiteracy","70 Years",{"count":82,"type":21},60,"OBSERVATIONAL","Bipolar disorders are mental illnesses characterized by the recurrence of mood-episodes, that can have a severe impact on the life of individuals. The effect of lithium, one of the main medications used to treat acute episodes or prevent them from happening, is very different from one individual to an-other. So far, there is no way to predict in advance for whom patient this treatment will be effective or for whom it will not.\n\nFinding markers that can predict as early as possible the efficiency of this treatment is a major field of current research in psychiatry, in order to avoid maintaining an inefficient treatment for several years that can have negative side-effects.\n\nOver the past decades, it has been shown by multiple studies that lithium can act on the biological clock, that regulates circadian rhythmicity of the body (i.e. rhythms that presents a 24 hours periods, such as rhythms of sleep and activity, feeding, social activities...). But it is still very unclear whether the effect of lithium in regulating the mood in bipolar disorders is mediated by this action.\n\nMelatonin is one of the key-regulator of circadian rhythmicity of the human body. Our hypothesis, based on some previous studies, is that the action of lithium in type-1 bipolar disorder (BD-I) is related to an action on melatonin secretion.\n\nTo test that, we want in this study to compare the noctunal secretion of melatonin between BD-I individuals with a good response to lithium versus with a poor response to lithium.",[30],[87],"lithium","2025-08-04",{"date":90,"type":36},"2025-08-08",{"date":92,"type":36},"2023-07-26",{"date":94,"type":21},"2026-07",{"name":96,"class":70},"Assistance Publique - Hôpitaux de Paris",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":97},"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":107,"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.",[110,30,31],"Schizoaffective Disorder, Depressive Type","2024-04-05",{"date":113,"type":36},"2024-04-08",{"date":115,"type":36},"2024-03-19",{"date":117,"type":21},"2028-02-02",{"name":119,"class":70},"Nantes University Hospital"]