177 completed, 22 terminated, 10 unknown, 9 recruiting. 229 Phase 3, 22 Phase 2.
Follow Bipolar Disorder: new trials by email Literature Review of Bipolar Disorder trials Research Report on Bipolar 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 |
|---|---|---|---|---|---|---|
| Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression Pramipexole, Placebo - Bipolar Disorder (BD) | Phase 3 | Recruiting | Daniel Lindqvist | 126 | 2026-10-01 | 2026-10-22 |
| Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II. Lacosamide, Placebo - Bipolar Affective Disorder | Phase 3 | Recruiting | University of Sao Paulo | 40 | 2026-01-09 | 2026-02-20 |
| An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE) Azetukalner - Bipolar Depression, Bipolar I Disorder | Phase 3 | Active not recruiting | Xenon Pharmaceuticals Inc. | 400 | 2025-10-30 | 2026-10-13 |
| A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine Xanomeline/Trospium Chloride, Placebo - Mania, Bipolar Disorder | Phase 3 | Recruiting | Bristol-Myers Squibb | 424 | 2025-10-08 | 2026-11-03 |
| A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) Azetukalner, Placebo - Bipolar Disorder, Bipolar Depression | Phase 3 | Active not recruiting | Xenon Pharmaceuticals Inc. | 400 | 2025-08-08 | 2026-10-13 |
| Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression MagPro X100/R30 stimulator, Cool-B70 coil - Bipolar Depression Depressed Phase | Phase 3 | Recruiting | Tyler Kaster | 80 | 2025-05-27 | 2026-10-05 |
| Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure Clozapine, Esketamine Nasal Product, Escitalopram - Schizophrenia and Related Disorders, Major Depressive Disorder | Phase 3 | Terminated | Dr. Inge Winter | 1 | 2025-04-27 | 2026-11-05 |
| The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. Escitalopram, Sertraline, Venlafaxine - Bipolar Depression | Phase 3 | Recruiting | Dr. Inge Winter | 418 | 2025-02-11 | 2025-09-26 |
| Study of Lumateperone in the Treatment of Patients With Bipolar Mania Lumateperone, Placebo - Bipolar Disorder, Manic | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 351 | 2024-07-17 | 2026-07-24 |
| Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy Sigma-Stim, RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) - Suicidal Ideation, Major Depressive Disorder | Phase 2 / Phase 3 | Active not recruiting | Michigan State University | 30 | 2024-07-03 | 2026-11-02 |
| Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania Lumateperone, Placebo - Bipolar Disorder, Manic | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 354 | 2024-06-19 | 2026-07-24 |
| BHV-7000 Acute Treatment of Bipolar Mania BHV-7000, Placebo - Bipolar Disorder | Phase 2 / Phase 3 | Completed | Biohaven Therapeutics Ltd. | 274 | 2024-05-28 | 2025-12-16 |
| Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients Lumateperone, Placebo - Bipolar Depression | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 384 | 2024-05-14 | 2026-11-03 |
| Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder Lumateperone - Schizophrenia, Bipolar Disorder | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 300 | 2024-01-25 | 2026-11-03 |
| Predictors of Intravenous Ketamine Response in TRD Ketamine, Midazolam - Treatment Resistant Depression, Major Depressive Disorder | Phase 3 | Active not recruiting | Abraham Nunes | 40 | 2024-01-19 | 2026-05-22 |
| Cannabidiol for Bipolar Depression (CBD-BD) Cannabidiol, Placebo - Bipolar Disorder | Phase 3 | Recruiting | University of British Columbia | 360 | 2023-10-15 | 2025-04-23 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) BXCL501, Matching Placebo - Agitation,Psychomotor, Bipolar I Disorder | Phase 3 | Completed | BioXcel Therapeutics Inc | 452 | 2022-11-21 | 2026-08-07 |
| NRX-101 for Bipolar Depression With Subacute Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation and Behavior | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 74 | 2022-05-12 | 2024-05-08 |
| Ketamine As an Adjunctive Therapy for Major Depression (2) Ketamine, Midazolam - Major Depressive Episode, Unipolar Depression | Phase 3 | Completed | University of Dublin, Trinity College | 63 | 2021-09-13 | 2025-02-13 |
| Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study Magnetic Seizure Therapy, Electroconvulsive Therapy - Major Depressive Disorder, Bipolar Depression | Phase 2 / Phase 3 | Completed | University of Sao Paulo | 100 | 2021-05-31 | 2026-09-29 |
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Mania (35) · Depression (31) · Psychotic Disorders (16) · Schizophrenia (16) · Depressive Disorder, Major (14) · Affective Disorders, Psychotic (6) · Mood Disorders (6) · Depressive Disorder (5) · Suicidal Ideation (5) · Mental Disorders (3) · Psychomotor Agitation (3) · Sleep Initiation and Maintenance Disorders (3) · Anxiety Disorders (2) · Depressive Disorder, Treatment-Resistant (2)
Bipolar and Related Disorders (229) · Mental Disorders (226) · Mood Disorders (223) · Nervous System Diseases (43) · Pathological Conditions, Signs and Symptoms (43) · Behavior (42) · Signs and Symptoms (42) · Neurobehavioral Manifestations (40) · Neurologic Manifestations (40) · Behavioral Symptoms (39) · Schizophrenia Spectrum and Other Psychotic Disorders (28) · Depressive Disorder (15) · Self-Injurious Behavior (6) · Nutritional and Metabolic Diseases (4) · Suicide (4)
Quetiapine Fumarate (28) · Lithium (18) · Valproic Acid (17) · Risperidone (16) · Aripiprazole (15) · Lamotrigine (14) · Lurasidone Hydrochloride (14) · ziprasidone (14) · Lithium Carbonate (12) · Olanzapine (11) · asenapine (8) · lumateperone (8) · Ketamine (6) · Sertraline (5) · Topiramate (5)
AstraZeneca (16) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (16) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (12) · Otsuka Pharmaceutical Development & Commercialization, Inc. (9) · University Hospitals Cleveland Medical Center (9) · Intra-Cellular Therapies, Inc. (8) · Organon and Co (8) · Sumitomo Pharma America, Inc. (8) · GlaxoSmithKline (7) · Lindner Center of HOPE (7) · University of British Columbia (5) · Astellas Pharma Inc (4) · Eli Lilly and Company (4) · National Cheng-Kung University Hospital (4) · NeuroRx, Inc. (4)
United States (129) · Canada (27) · Russia (24) · Ukraine (21) · Bulgaria (18) · India (17) · Germany (15) · Colombia (14) · France (14) · Japan (14) · Serbia (14) · Poland (13) · Romania (12) · South Africa (12) · Taiwan (12)
Intra-Cellular Therapies, Inc. Clinical Trial (4) · Susan Kozauer, MD (4) · Keming Gao, MD, PhD (3) · Martin Brecher, MD (3) · Ru-Band Lu, MD (3) · BioXcel MM (2)
PMID 34523118, PMID 32792252, PMID 41017591, PMID 18588360, PMID 19956459, PMID 22198448, PMID 23473546, PMID 23609405, PMID 23761037, PMID 24111980, PMID 24329543, PMID 25978742, PMID 26598478, PMID 26730454, PMID 27215976, PMID 27529375, PMID 29105003, PMID 31969269, PMID 32942346, PMID 33677183, PMID 33915374, PMID 35394365, PMID 37339360, PMID 37551609, PMID 39098761, PMID 39520655, PMID 41401709, PMID 10609422, PMID 10831476, PMID 10941997, PMID 11018230, PMID 11196004, PMID 11252648, PMID 11256459, PMID 11349236, PMID 11511403, PMID 11522262, PMID 11593071, PMID 11748774, PMID 11772699, PMID 11869753, PMID 11874212, PMID 11874218, PMID 11903206, PMID 12023929, PMID 12027038, PMID 12091192, PMID 12397882, PMID 12562742, PMID 14525558
2016 (2), 2023 (2), 2004 (1), 2019 (1), 2025 (1), R01DK097599 (1), R01MH050165 (1), R01MH063632 (1), R01MH069801 (1), R01MH073817 (1), R01MH073871 (1), R01MH074033 (1), R01MH074707 (1), R01MH078060 (1), R01MH079261 (1)