177 completed. 177 Phase 3, 15 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 177 | Completed 177 |
| Phase 2 | 15 | Completed 15 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder Lumateperone, Placebos - Bipolar Depression, Major Depressive Disorder | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 488 | 2020-02-27 | 2025-03-19 |
| Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film - Agitation Associated With Bipolar Disorder, Agitation,Psychomotor | Phase 3 | Completed | BioXcel Therapeutics Inc | 380 | 2020-02-24 | 2026-08-11 |
| NRX101 Glx Biomarker Validation Study NRX-101, Lurasidone HCl, Placebo - Bipolar Depression, Suicidal Ideation | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 8 | 2018-11-01 | 2022-08-09 |
| A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania Probio-Tec BG-VCap-6.5, Placebo - Mania (Neurotic) | Phase 3 | Completed | University of Texas Southwestern Medical Center | 67 | 2018-09-06 | 2025-12-19 |
| Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally Lumateperone, Placebo - Bipolar Depression | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 381 | 2017-11-27 | 2022-06-03 |
| Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients lurasidone, Placebo - Bipolar Disorder | Phase 3 | Completed | Lakshmi N Yatham | 100 | 2017-05-08 | 2025-02-14 |
| Aripiprazole for Bipolar Disorder and Alcohol Use Disorder Aripiprazole, Placebo - Bipolar Disorder, Alcoholism | Phase 3 | Completed | University of Texas Southwestern Medical Center | 75 | 2016-11-01 | 2024-09-19 |
| Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression Minocycline, Celecoxib, Placebo - Depression, Bipolar Disorder | Phase 3 | Completed | Pakistan Institute of Living and Learning | 265 | 2016-08-01 | 2019-08-05 |
| Trehalose as add-on Therapy in Bipolar Depression Trehalose, Maltose - Bipolar Disorder, Bipolar Depression | Phase 3 | Completed | Consorcio Centro de Investigación Biomédica en Red (CIBER) | 60 | 2016-06-01 | 2023-02-08 |
| Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder Cariprazine, Placebo - Bipolar Disorder, Depression | Phase 3 | Completed | Forest Laboratories | 493 | 2016-03-31 | 2019-03-12 |
| Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression Cariprazine, Placebo - Bipolar Disorder, Depression | Phase 3 | Completed | Forest Laboratories | 488 | 2016-03-17 | 2019-01-30 |
| Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression Lumateperone (ITI-007), Placebo - Bipolar Depression | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 529 | 2016-03-07 | 2023-05-17 |
| Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression ITI-007 (Lumateperone), Placebo - Bipolar Depression | Phase 3 | Completed | Intra-Cellular Therapies, Inc. | 554 | 2015-12-15 | 2025-11-03 |
Showing 20 of 177. Sign in to see all of them.
Mania (32) · Depression (20) · Psychotic Disorders (13) · Schizophrenia (11) · Depressive Disorder, Major (9) · Affective Disorders, Psychotic (6) · Mood Disorders (5) · Depressive Disorder (4) · Mental Disorders (3) · Anxiety Disorders (2) · Psychomotor Agitation (2) · Sleep Initiation and Maintenance Disorders (2) · Social Stigma (2) · Substance-Related Disorders (2)
Bipolar and Related Disorders (177) · Mental Disorders (174) · Mood Disorders (172) · Pathological Conditions, Signs and Symptoms (38) · Nervous System Diseases (37) · Signs and Symptoms (37) · Neurobehavioral Manifestations (35) · Neurologic Manifestations (35) · Behavior (27) · Behavioral Symptoms (24) · Schizophrenia Spectrum and Other Psychotic Disorders (22) · Depressive Disorder (8) · Chemically-Induced Disorders (3) · Aberrant Motor Behavior in Dementia (2) · Body Weight (2)
Quetiapine Fumarate (24) · Risperidone (16) · Valproic Acid (16) · Lamotrigine (13) · Lithium (13) · Lurasidone Hydrochloride (13) · Aripiprazole (12) · Olanzapine (10) · Lithium Carbonate (9) · asenapine (8) · ziprasidone (8) · lumateperone (6) · Topiramate (5) · 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide (4) · Sugars (4)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (16) · AstraZeneca (15) · Organon and Co (8) · Otsuka Pharmaceutical Development & Commercialization, Inc. (8) · Sumitomo Pharma America, Inc. (8) · GlaxoSmithKline (7) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (7) · University Hospitals Cleveland Medical Center (7) · Intra-Cellular Therapies, Inc. (6) · Astellas Pharma Inc (4) · Eli Lilly and Company (4) · Lindner Center of HOPE (4) · University of Pittsburgh (4) · Forest Laboratories (3) · Novartis Pharmaceuticals (3)
United States (106) · Russia (23) · Ukraine (18) · Canada (17) · Bulgaria (15) · India (14) · France (13) · Japan (13) · South Africa (12) · Colombia (11) · Germany (11) · Poland (11) · Serbia (11) · Romania (10) · Taiwan (10)
Susan Kozauer, MD (4) · BioXcel MM (2) · Catherine Datto, MD (2) · Erin Michalak (2) · Intra-Cellular Therapies, Inc. Clinical Trial (2) · Jehannine Austin, PhD, CCGC, CGC (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 37339360, PMID 37551609, PMID 39098761, PMID 39520655, 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, PMID 14702242, PMID 15169694
2016 (2), 2004 (1), 2019 (1), R01DK097599 (1), R01MH050165 (1), R01MH063632 (1), R01MH069801 (1), R01MH073817 (1), R01MH073871 (1), R01MH074033 (1), R01MH074707 (1), R01MH078060 (1), R01MH079261 (1), R21MH067055 (1), R34MH080958 (1)