45 completed, 4 recruiting, 1 terminated, 1 unknown. 52 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 52 | Completed 45, Recruiting 4, Terminated 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 1 | Completed 1 |
Follow Mania: new trials by email Literature Review of Mania trials Research Report on Mania
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 |
|---|---|---|---|---|---|---|
| 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 Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) KarXT, Lithium, Valproate - Bipolar Disorder Type I With Mania | Phase 3 | Recruiting | Bristol-Myers Squibb | 450 | 2025-07-18 | 2026-10-26 |
| A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2) KarXT, Placebo - Bipolar Disorder Type I With Mania or Mania With Mixed Features | Phase 3 | Recruiting | Bristol-Myers Squibb | 274 | 2025-06-13 | 2026-11-10 |
| A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder KarXT, Placebo - Bipolar-I Disorder With Mania or Mania With Mixed Features | Phase 3 | Recruiting | Bristol-Myers Squibb | 274 | 2025-06-11 | 2026-10-23 |
| 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 |
| 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 |
| A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features Cariprazine, Placebo - Bipolar I Disorder, Mania | Phase 3 | Completed | AbbVie | 901 | 2018-06-15 | 2023-09-28 |
| A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. Brexpiprazole - Bipolar I Disorder, Acute Mania | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 381 | 2017-10-24 | 2020-08-17 |
| A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder Brexpiprazole, Placebo - Bipolar I Disorder, Manic Episode | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 333 | 2017-09-19 | 2020-02-11 |
| A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder Brexpiprazole, Placebo - Bipolar I Disorder, Manic Episode | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 322 | 2017-09-14 | 2020-02-10 |
| Methylphenidate for the Treatment of Acute Mania methylphenidate, Placebo - Mania | Phase 3 | Completed | Michael Kluge | 42 | 2012-03-01 | 2016-06-10 |
| Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence Citicoline, Placebo - Mania, Hypomania | Phase 3 | Completed | University of Texas Southwestern Medical Center | 44 | 2010-07-01 | 2014-08-11 |
| Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. Aripiprazole - Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 524 | 2010-07-01 | 2016-02-08 |
| Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) ziprasidone oral capsules - Bipolar Disorder | Phase 3 | Withdrawn | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 2010-07-01 | 2021-02-21 | |
| Allopurinol for Mania: A Randomized Trial Administering Allopurinol vs. Placebo as add-on to Mood Stabilizers and/or Antipsychotics in Patients in a Bipolar Manic Episode Allopurinol, Placebo - Mania | Phase 3 | Completed | Sheba Medical Center | 180 | 2010-05-01 | 2012-05-08 |
| Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder Cariprazine - Bipolar I Disorder | Phase 3 | Completed | Forest Laboratories | 403 | 2010-02-28 | 2019-06-13 |
| Safety and Efficacy of Cariprazine for Bipolar I Disorder Cariprazine, Placebo - Mania, Bipolar I Disorder | Phase 3 | Completed | Forest Laboratories | 497 | 2010-02-01 | 2017-04-12 |
| Safety and Efficacy of Cariprazine for Mania Cariprazine, Placebo - Bipolar Disorder, Mania | Phase 3 | Completed | Forest Laboratories | 323 | 2010-02-01 | 2017-04-17 |
| Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes Phenytoin (brand name Dilantin), Hydrocortisone, Placebo - Healthy | Phase 3 | Completed | University of Texas Southwestern Medical Center | 17 | 2008-01-01 | 2015-08-19 |
| Safety and Efficacy Study of Lithium in Bipolar Disorder Lithium Carbonate Capsule - Bipolar Disorder, Mania | Phase 3 | Unknown | JDS Pharmaceuticals | 206 | 2007-01-01 | 2007-08-14 |
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Bipolar Disorder (35) · Affective Disorders, Psychotic (5) · Psychotic Disorders (5) · Depression (4) · Mood Disorders (4) · Schizophrenia (3) · Cocaine-Related Disorders (1) · Mental Disorders (1) · Teratogenesis (1)
Nervous System Diseases (52) · Neurobehavioral Manifestations (52) · Neurologic Manifestations (52) · Pathological Conditions, Signs and Symptoms (52) · Signs and Symptoms (52) · Mental Disorders (37) · Bipolar and Related Disorders (35) · Mood Disorders (31) · Schizophrenia Spectrum and Other Psychotic Disorders (11) · Behavior (4) · Behavioral Symptoms (4) · Chemically-Induced Disorders (1) · Pathologic Processes (1) · Substance-Related Disorders (1)
Risperidone (7) · Valproic Acid (6) · Lithium (5) · Topiramate (5) · 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide (4) · Quetiapine Fumarate (4) · cariprazine (4) · trospium chloride (4) · xanomeline (4) · Aripiprazole (3) · Lithium Carbonate (3) · Olanzapine (3) · Paliperidone Palmitate (3) · brexpiprazole (3) · Adrenal Cortex Hormones (1)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (13) · Otsuka Pharmaceutical Development & Commercialization, Inc. (6) · Bristol-Myers Squibb (4) · Abbott (3) · Forest Laboratories (3) · Novartis Pharmaceuticals (3) · University of Texas Southwestern Medical Center (3) · AstraZeneca (2) · Eli Lilly and Company (2) · AbbVie (1) · Beersheva Mental Health Center (1) · Biohaven Therapeutics Ltd. (1) · JDS Pharmaceuticals (1) · Janssen Pharmaceutica N.V., Belgium (1) · Michael Kluge (1)
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Elizabeth Diaz, MD (3) · Matthew Leoni, M.D. (2) · Alan G. Mallinger, M.D. (1) · Barbara Geller, MD (1) · Catherine Datto, MD (1) · Clara Gu (1) · E. Sherwood Brown, PH.D., M.D. (1) · Eva Kohegyi, MD (1)
PMID 19325497, PMID 29017067, PMID 31344528, PMID 12091192, PMID 12562742, PMID 15169694, PMID 15572276, PMID 16086617, PMID 16135859, PMID 17107240, PMID 17335331, PMID 19594501, PMID 19906348, PMID 20361904, PMID 20565430, PMID 20624657, PMID 20947174, PMID 21823911, PMID 22054797, PMID 22134043, PMID 22213771, PMID 22377512, PMID 22917200, PMID 23437959, PMID 23480324, PMID 25562205, PMID 26598475, PMID 26598476, PMID 28843918, PMID 29174864, PMID 35235061
2017 (2), 2025 (1), R01MH069801 (1), U01MH064846 (1), U01MH064850 (1), U01MH064868 (1), U01MH064869 (1), U01MH064887 (1), U01MH064911 (1)