5 completed, 4 recruiting, 2 enrolling by invitation, 2 not yet recruiting. 3 Not applicable, 3 Phase 2, 3 Phase 3, 3 Phase 4.
Follow Bipolar 1 Disorder: new trials by email Literature Review of Bipolar 1 Disorder trials Research Report on Bipolar 1 Disorder
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Risperidone vs Cariprazine in Acute Mania Risperidone, Cariprazine - Bipolar 1 Disorder | Phase 4 | Not yet recruiting | Pakistan Institute of Medical Sciences | 50 | 2027-06-01 | 2026-06-24 |
| Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial Stimulation by the Sigma ECT/FEAST device, Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL), Stimulation by Sigmastim ECT 200J device administered in bilateral (BT) - Major Depressive Episode (MDE), Unipolar Disorder | Not applicable | Not yet recruiting | Centre Hospitalier St Anne | 108 | 2026-11-02 | 2026-10-05 |
| Socio-cognitive and Biological Responses to Maltreatment Bipolar 1 Disorder, Control Subjects | Recruiting | Medical University Innsbruck | 160 | 2026-07-20 | 2026-10-07 | |
| Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder Alzheimer Disease, Dementia With Lewy Bodies (DLB) | Enrolling by invitation | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | 1799 | 2026-02-19 | 2026-02-23 | |
| Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders Major Depressive Disorder (MDD), Schizophenia Disorder | Enrolling by invitation | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | 1310 | 2026-02-01 | 2026-04-24 | |
| Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder RAP-219, Placebo - Bipolar 1 Disorder | Phase 2 | Active not recruiting | Rapport Therapeutics Inc. | 253 | 2025-07-25 | 2026-08-10 |
| Feasibility and Preliminary Results of the Efficacy of Blue-Blocking Glasses on Manic Symptoms in Bipolar Disorder Blue-blocking glasses - Bipolar 1 Disorder | Not applicable | Recruiting | Centre Hospitalier St Anne | 25 | 2024-07-19 | 2025-09-26 |
| Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients Endoxifen enteric-coated tablet (8 mg), Placebo Tablets - Bipolar 1 Disorder | Phase 3 | Unknown | Jina Pharmaceuticals Inc. | 490 | 2024-03-19 | 2025-03-17 |
| Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia | Recruiting | Beth Israel Deaconess Medical Center | 320 | 2023-01-01 | 2026-03-10 | |
| Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning Circadian Rhythms for Mood (CRM) application - Active, Circadian Rhythms for Mood (CRM) application - Sham - Major Depressive Disorder, Bipolar 1 Disorder | Not applicable | Completed | Hucircadian | 93 | 2022-05-27 | 2025-03-17 |
| CLOZAPINE Response in Biotype-1 clozapine, risperidone - Schizophrenia, Schizoaffective Disorder | Phase 4 | Recruiting | University of Texas Southwestern Medical Center | 524 | 2022-03-01 | 2026-05-11 |
| A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease There is no intervention in this study - Gut Microbiome, Gastrointestinal Microbiome | Suspended | ProgenaBiome | 1000 | 2019-07-11 | 2026-09-21 | |
| A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder Abilify MyCite - Digital Medicine System, Aripiprazole or other oral antipsychotics - Schizophrenia, Bipolar 1 Disorder | Phase 4 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2 | 2018-06-28 | 2019-11-08 |
| Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder Schizophrenia, Bipolar 1 Disorder | Completed | Korea Otsuka Pharmaceutical Co., Ltd. | 1030 | 2016-12-13 | 2022-02-14 | |
| Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder Aripiprazole, Ingestible Event Marker (IEM) - Bipolar 1 Disorder, Schizophrenia | Phase 2 | Withdrawn | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2014-03-01 | 2015-04-28 | |
| Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia Bipolar 1 Disorder, Schizophrenia | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 47 | 2013-12-01 | 2014-01-31 | |
| Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder ELND005, Lamotrigine, Valproic acid - Bipolar 1 Disorder | Phase 2 | Terminated | OPKO Health, Inc. | 309 | 2012-08-01 | 2019-10-21 |
| Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) Asenapine, Placebo - Bipolar 1 Disorder | Phase 3 | Completed | Organon and Co | 367 | 2012-04-06 | 2024-06-18 |
| Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384) asenapine, placebo - Bipolar 1 Disorder | Phase 3 | Completed | Forest Laboratories | 561 | 2011-12-01 | 2015-12-04 |
| An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315) OLZ/SAM - Bipolar 1 Disorder, Schizophrenia Disorder | Available | Alkermes, Inc. | 2026-08-04 |
Schizophrenia (7) · Depressive Disorder, Major (6) · Bipolar Disorder (4) · Alzheimer Disease (3) · Parkinson Disease (3) · Frontotemporal Dementia (2) · Lewy Body Disease (2) · Mania (2) · Mental Disorders (2) · Nervous System Diseases (2) · Psychotic Disorders (2) · Treatment Adherence and Compliance (2) · Acne Vulgaris (1) · Amyotrophic Lateral Sclerosis (1) · Anxiety Disorders (1)
Mental Disorders (10) · Mood Disorders (7) · Depressive Disorder (6) · Schizophrenia Spectrum and Other Psychotic Disorders (6) · Nervous System Diseases (5) · Basal Ganglia Diseases (3) · Behavior (3) · Bipolar and Related Disorders (3) · Brain Diseases (3) · Central Nervous System Diseases (3) · Dementia (3) · Metabolic Diseases (3) · Movement Disorders (3) · Neurocognitive Disorders (3) · Neurodegenerative Diseases (3)
Aripiprazole (2) · Risperidone (2) · asenapine (2) · 3-carboxamido-4-hydroxynaltrexone (1) · Circadian Rhythm (1) · Clozapine (1) · Lamotrigine (1) · Olanzapine (1) · Valproic Acid (1) · cariprazine (1) · lybalvi (1) · picolinic acid (1) · scyllitol (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (3) · Centre Hospitalier St Anne (2) · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (2) · Alkermes, Inc. (1) · Beth Israel Deaconess Medical Center (1) · Forest Laboratories (1) · Hucircadian (1) · Jina Pharmaceuticals Inc. (1) · Korea Otsuka Pharmaceutical Co., Ltd. (1) · Medical University Innsbruck (1) · OPKO Health, Inc. (1) · Organon and Co (1) · Pakistan Institute of Medical Sciences (1) · ProgenaBiome (1) · Rapport Therapeutics Inc. (1)
United States (11) · France (3) · Spain (3) · Bulgaria (2) · Romania (2) · South Korea (2) · Turkey (Türkiye) (2) · Austria (1) · Canada (1) · Croatia (1) · Czechia (1) · India (1) · Monaco (1) · Philippines (1) · Poland (1)
Carol Tamminga, M.D. (1) · Edwin A Gomez, MD (1) · Kimberly Largay, MD (1) · Matcheri S. Keshavan, MD (1) · Sabine Hazan, MD (1) · Shashank Rohatagi, PhD (1)
PMID 26496015, PMID 28946761, PMID 35483736, PMID 39086163
R01MH127174 (1)