[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurocrine Biosciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":332},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,71,92,119,143,162,186,207,234,258,280,299,316],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100590100","phase-3-nbi-1065845-mdd3026-study-to-assess-the-efficacy-and-safety-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100590100",false,"NCT06963021","NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)","A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.\n* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.\n* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.\n* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).\n* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.\n\nKey Exclusion Criteria:\n\n* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.\n* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.\n* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.",[26],"Major Depressive Disorder",[28,29,26,30,31,32],"MDD","Depression","NBI-1065845","TAK-653","MADRS","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2025-05-30",{"date":41,"type":20},"2027-07",{"name":43,"class":44},"Neurocrine Biosciences","INDUSTRY",34,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100621041","phase-2-efficacy-safety-and-tolerability-of-nbi-1065890-versus-placebo-in-adults-with-tardive-dyskinesia-100621041","NCT07365462","Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia","Key Inclusion Criteria:\n\n* Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening.\n* Medically confirmed diagnosis of neuroleptic-induced TD as defined in the DSM-5 for at least 3 months prior to screening.\n* Moderate or severe TD (AIMS Item 8, severity of abnormal movement overall) as assessed by a blinded, external AIMS video reviewer using a video recording of the participant's AIMS assessment administered at the clinical site by a blinded, certified site AIMS rater. The AIMS dyskinesia total score (sum of Items 1 to 7) must be ≥6 as assessed by the blinded, external AIMS video reviewer.\n\nKey Exclusion Criteria:\n\n* Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs\u002Fsymptoms, as documented by a score on the Modified Simpson-Angus Scale (mSAS) (excluding Items 8 and 10) \\>6 at screening or Day -1 (baseline) or a score \\>3 in any one item (excluding Items 8 and 10).\n* Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at screening or Day -1.\n* Brief Psychiatric Rating Scale (BPRS) total score ≥50 at screening or Day -1.\n* Hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or MDD within 6 months of screening.\n* Participant has an unstable medical condition or unstable chronic disease.\n* Any known history of neuroleptic malignant syndrome (NMS).\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","75 Years",{"count":55,"type":20},100,[57],"PHASE2","The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.",[60],"Tardive Dyskinesia",[60,62],"NBI-1065890","2026-06-19",{"date":36,"type":37},{"date":66,"type":37},"2026-02-06",{"date":68,"type":20},"2027-03",{"name":43,"class":44},18,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100590360","phase-3-long-term-study-to-assess-the-safety-and-tolerability-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100590360","NCT06966401","Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)","A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.\n* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.\n* Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.\n* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.\n\nKey Exclusion Criteria:\n\n* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.\n* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.\n\nOther protocol defined inclusion and exclusion criteria apply.",{"count":79,"type":20},850,[23],"This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.",[26],[28,29,26,30,31],"2026-06-18",{"date":34,"type":37},{"date":87,"type":37},"2025-04-16",{"date":89,"type":20},"2030-05",{"name":43,"class":44},98,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100601024","phase-4-a-study-to-evaluate-the-effectiveness-of-valbenazine-in-adult-participants-with-tardive-dyskinesia-td-who-remain-symptomatic-while-receiving-or-after-stopping-a-vesicular-monoamine-transporter-2-vmat2-inhibitor-100601024","NCT07105111","A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor","Key Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder\n* Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening\n\nKey Exclusion Criteria:\n\n* Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD\n* Diagnosis of moderate or severe substance use disorder in the last 6 months\n* History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment",{"count":100,"type":20},50,[102],"PHASE4","This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.",[105,106,107,26,60],"Schizophrenia","Schizoaffective Disorder","Bipolar Disorder",[109],"Valbenazine","2026-06-15",{"date":112,"type":37},"2026-06-16",{"date":114,"type":37},"2025-08-29",{"date":116,"type":20},"2027-01",{"name":43,"class":44},22,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100610456","phase-3-efficacy-of-nbi-1117568-in-preventing-relapse-in-adults-with-schizophrenia-100610456","NCT07227818","Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia","A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.\n* Participant had the initial diagnosis of schizophrenia ≥1 year before screening.\n* Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.\n\nKey Exclusion Criteria:\n\n* Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \\[including dementing illness, myasthenia gravis\\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1.\n* Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.\n* Participant has a history of clozapine treatment for treatment-resistant psychosis.\n* Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening.\n* Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.","65 Years",{"count":128,"type":20},560,[23],"The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.",[105],[105,133],"NBI-1117568","2026-06-04",{"date":136,"type":37},"2026-06-05",{"date":138,"type":37},"2025-12-16",{"date":140,"type":20},"2029-07",{"name":43,"class":44},20,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100601775","phase-3-nbi-1117568-scz3032-long-term-evaluation-of-nbi-1117568-in-adults-with-schizophrenia-100601775","NCT07114874","NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia","A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia\n* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation\n* Participant must reside in a stable housing situation\n\nKey Exclusion Criteria:\n\n* Participant has known hypersensitivity to any component of the formulation of NBI-1117568\n* Participant has an unstable or poorly controlled medical condition or chronic disease\n* Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others\n* Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening\n* Participant has a positive alcohol test or drug screen for disallowed substances\n* Participant has a history of poor or suspected poor compliance in clinical research studies and\u002For in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.",{"count":151,"type":20},600,[23],"This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.",[105],{"date":136,"type":37},{"date":157,"type":37},"2025-07-11",{"date":159,"type":20},"2031-12",{"name":43,"class":44},57,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100615109","phase-2-evaluation-of-nbi-1117570-in-inpatient-adults-with-schizophrenia-100615109","NCT07288333","Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia","A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization","Key Inclusion Criteria:\n\n* 18 to 55 years of age\n* Primary diagnosis of schizophrenia ≥1 year before screening.\n* Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.\n* Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.\n\nKey Exclusion Criteria:\n\n* Considered to be at imminent risk of suicide or injury to self or others.\n* History of epilepsy, seizures, or convulsions.\n* Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation.\n* Currently taking prohibited medications.\n* Pregnant or lactating.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.","55 Years",{"count":171,"type":20},120,[57],"The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.",[105],[105,176],"NBI-1117570","2026-05-22",{"date":179,"type":37},"2026-05-26",{"date":181,"type":37},"2026-02-16",{"date":183,"type":20},"2027-08",{"name":43,"class":44},5,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100601023","phase-3-nbi-1117568-scz3030-evaluation-of-nbi-1117568-in-inpatient-adults-with-schizophrenia-100601023","NCT07105098","NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia","A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia\n* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.\n* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation\n* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements\n\nKey Exclusion Criteria:\n\n* Participant has known hypersensitivity to any component of the formulation of NBI-1117568\n* Participant has an unstable or poorly controlled medical condition or chronic disease\n* Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others\n* Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening\n* Participant has a positive alcohol test or drug screen for disallowed substances\n* Participant has a history of poor or suspected poor compliance in clinical research studies and\u002For in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.",{"count":194,"type":20},284,[23],"The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.",[105],"2026-05-13",{"date":200,"type":37},"2026-05-15",{"date":202,"type":37},"2025-08-11",{"date":204,"type":20},"2027-11",{"name":43,"class":44},15,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100634175","phase-2-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-crinecerfont-in-participants-with-classic-congenital-adrenal-hyperplasia-cah-who-are-less-than-4-years-old-100634175","NCT07536269","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old","A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Crinecerfont in Pediatric Participants 3 Months to \u003C4 Years of Age With Classic Congenital Adrenal Hyperplasia","Key Inclusion Criteria:\n\n* Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD)\n* Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening.\n* Have a body weight of at least 4.5 kilograms (kg) at screening.\n* Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation by a pediatric specialist.\n\nKey Exclusion Criteria:\n\n* Have a known or suspected diagnosis of any of the other forms of classic CAH.\n* Have any condition besides CAH that requires chronic daily therapy with orally administered steroids.\n* Have any other clinically significant medical condition or chronic disease.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","3 Months","47 Months",{"count":142,"type":20},[57],"The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \\\u003C4 years of age with CAH.",[220],"Congenital Adrenal Hyperplasia",[220,222,223,224],"CAH","Crinecerfont","Pediatric","NOT_YET_RECRUITING","2026-04-10",{"date":228,"type":37},"2026-04-17",{"date":230,"type":20},"2026-04",{"date":232,"type":20},"2028-03",{"name":43,"class":44},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100615108","phase-2-an-assessment-of-efficacy-safety-and-pharmacokinetics-of-nbi-1117568-in-adults-with-bipolar-i-disorder-with-current-mania-100615108","NCT07288320","An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of bipolar I disorder.\n* The participant has had at least 1 prior documented manic episode that required treatment.\n* The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms.\n\nKey Exclusion Criteria:\n\n* Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.\n* Primary diagnosis is not bipolar I disorder.\n* History of clozapine treatment for treatment-resistant psychosis.\n* History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.",{"count":242,"type":20},150,[57],"The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.",[246,247],"Bipolar I Disorder","Mania",[246,247,133],"2026-03-20",{"date":251,"type":37},"2026-03-24",{"date":253,"type":37},"2025-12-24",{"date":255,"type":20},"2028-02",{"name":43,"class":44},6,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},"100608049","phase-3-a-study-to-evaluate-the-maintenance-effect-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100608049","NCT07196501","A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.\n* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.\n* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.\n* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).\n* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.\n\nKey Exclusion Criteria:\n\n* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.\n* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.\n* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":266,"type":20},550,[23],"The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.",[26],[26,28,30],"2026-03-17",{"date":273,"type":37},"2026-03-19",{"date":275,"type":37},"2025-08-18",{"date":277,"type":20},"2028-07",{"name":43,"class":44},45,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":196,"conditions":289,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100590101","phase-3-nbi-1117568-scz3029-evaluation-of-nbi-1117568-in-inpatient-adults-with-schizophrenia-100590101","NCT06963034","NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of schizophrenia\n* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.\n* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation\n* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements\n\nKey Exclusion Criteria:\n\n* Participant has known hypersensitivity to any component of the formulation of NBI-1117568.\n* Participant has an unstable or poorly controlled medical condition or chronic disease\n* Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others\n* Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening\n* Participant has a positive alcohol test or drug screen for disallowed substances\n* Participants have a history of poor or suspected poor compliance in clinical research studies and\u002For in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.",{"count":194,"type":20},[23],[105],"2026-03-05",{"date":292,"type":37},"2026-03-06",{"date":294,"type":37},"2025-05-08",{"date":296,"type":20},"2027-10",{"name":43,"class":44},21,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":24,"conditions":306,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":314,"locationsCount":315},"100586110","phase-3-nbi-1065845-mdd3025-study-to-assess-the-efficacy-and-safety-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100586110","NCT06911112","NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)",{"count":19,"type":20},[23],[26],[28,29,26,30,31,32],"2025-11-26",{"date":310,"type":37},"2025-12-01",{"date":312,"type":37},"2025-03-31",{"date":41,"type":20},{"name":43,"class":44},10,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":24,"conditions":323,"keywords":324,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":331,"locationsCount":70},"100576540","phase-3-study-to-assess-the-efficacy-and-safety-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100576540","NCT06786624","Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)",{"count":19,"type":20},[23],[26],[28,29,26,30,31,32],"2025-10-28",{"date":327,"type":37},"2025-10-29",{"date":329,"type":37},"2025-01-22",{"date":41,"type":20},{"name":43,"class":44},""]