123 completed, 11 recruiting, 11 unknown, 8 terminated. 52 Phase 3, 34 Phase 4, 24 Phase 2, 23 Not applicable, 4 Phase 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 |
|---|---|---|---|---|---|---|
| An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania NBI-1117568, Placebo - Bipolar I Disorder, Mania | Phase 2 | Recruiting | Neurocrine Biosciences | 150 | 2025-12-24 | 2026-09-29 |
| 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 |
| Immune Mechanisms of Antipsychotic Treatment Response Psychosis | Recruiting | King's College London | 500 | 2025-08-06 | 2026-03-25 | |
| Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder RAP-219, Placebo - Bipolar 1 Disorder | Phase 2 | Completed | Rapport Therapeutics Inc. | 253 | 2025-07-25 | 2026-10-26 |
| 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 |
| LRFN5 and OLFM4 in Bipolar Disorder Bipolar Disorder (BD) | Completed | Elazığ Mental Health and Diseases Hospital | 72 | 2025-07-07 | 2026-06-29 | |
| 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 |
| Effect of Blue Light Blocking on Reducing Manic Symptoms in Bipolar Disorder Blue-blocking glasses, Clear glasses - Bipolar, Manic | Not applicable | Not yet recruiting | Rayan NASSERDINE | 96 | 2025-04-01 | 2024-12-27 |
| A Novel Blood Test as a Biomarker in Mental Health Depression - Major Depressive Disorder, Schizophenia Disorder | Recruiting | Fraser Health | 500 | 2025-03-25 | 2026-03-05 | |
| LHC-CIDI-5 in Hong Kong CIDI-5, LHC-CIDI-5 - Major Depressive Episode (MDE), Major Depressive Disorder (MDD) | Recruiting | The University of Hong Kong | 2500 | 2025-01-18 | 2026-03-10 | |
| Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS (R)-3-hydroxybutyl (R)-3-hydroxybutyrate), Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride - Schizophrenia and Related Disorders, Psychosis | Not applicable | Completed | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 28 | 2024-12-01 | 2026-04-27 |
| Clocks in Sync - Circadian Rhythm and Bipolar Mania Blue-blocking glasses, Time-restricted eating, Lightly tinted glasses - Bipolar Disorder, Mania | Not applicable | Completed | Ottawa Hospital Research Institute | 21 | 2024-09-17 | 2026-02-18 |
| Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas blood sample - Bipolar Disorder | Unknown | Assiut University | 100 | 2024-09-05 | 2024-08-30 | |
| 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 |
| BHV-7000 Open-Label Extension Bipolar Mania Study BHV-7000 - Bipolar Disorder | Phase 2 | Terminated | Biohaven Therapeutics Ltd. | 94 | 2024-06-24 | 2025-12-16 |
| 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 |
| Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa mHealer - Psychosis, Mania | Not applicable | Recruiting | University of Washington | 360 | 2023-10-25 | 2024-07-25 |
| CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB Cognitive Behavioural Therapy for Problematic Impulsive Behaviours - Impulsivity, Bipolar Disorder | Not applicable | Suspended | University of Exeter | 10 | 2023-08-17 | 2025-04-30 |
| Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum Schizophrenia, Psychosis | Completed | University of Liverpool | 168 | 2023-08-01 | 2026-04-07 |
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Bipolar Disorder (114) · Depression (36) · Psychotic Disorders (22) · Schizophrenia (14) · Mood Disorders (12) · Alcoholism (7) · Depressive Disorder, Major (7) · Affective Disorders, Psychotic (5) · Anxiety Disorders (5) · Substance-Related Disorders (5) · Depressive Disorder (4) · Mental Disorders (3) · Behavior, Addictive (2) · Generalized Anxiety Disorder (2)
Nervous System Diseases (158) · Neurobehavioral Manifestations (158) · Neurologic Manifestations (158) · Pathological Conditions, Signs and Symptoms (158) · Signs and Symptoms (158) · Mental Disorders (125) · Bipolar and Related Disorders (114) · Mood Disorders (106) · Behavior (41) · Behavioral Symptoms (38) · Schizophrenia Spectrum and Other Psychotic Disorders (34) · Chemically-Induced Disorders (9) · Alcohol-Related Disorders (7) · Depressive Disorder (7) · Pathologic Processes (4)
Lithium (13) · Quetiapine Fumarate (13) · Risperidone (10) · Valproic Acid (10) · Lithium Carbonate (6) · Olanzapine (6) · 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide (5) · Aripiprazole (5) · Lamotrigine (5) · Topiramate (5) · cariprazine (5) · Allopurinol (4) · trospium chloride (4) · xanomeline (4) · ziprasidone (4)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (13) · Massachusetts General Hospital (13) · National Institute of Mental Health (NIMH) (8) · AstraZeneca (7) · Mclean Hospital (7) · Otsuka Pharmaceutical Development & Commercialization, Inc. (7) · Forest Laboratories (5) · Bristol-Myers Squibb (4) · University of Texas Southwestern Medical Center (4) · Abbott (3) · Eli Lilly and Company (3) · Medical University of South Carolina (3) · Novartis Pharmaceuticals (3) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (3) · University of Cincinnati (3)
United States (91) · Ukraine (15) · Poland (12) · Bulgaria (10) · Canada (10) · Russia (10) · Romania (8) · China (7) · France (7) · Germany (7) · India (7) · Israel (7) · Australia (6) · Croatia (6) · Serbia (6)
Janet Wozniak, MD (5) · Joseph Biederman, MD (4) · Beth L Murphy, MD, PhD (3) · Elizabeth Diaz, MD (3) · Amit Anand, MD (2) · Kathleen T Brady, M.D., Ph.D. (2) · Matthew Leoni, M.D. (2) · Melissa DelBello, MD (2) · Robert J. DeRubeis, PhD (2)
PMID 29017067, PMID 31344528, PMID 19325497, PMID 11765093, PMID 12091192, PMID 12562742, PMID 15005752, PMID 15110730, PMID 15169694, PMID 15330403, PMID 15349007, PMID 15465989, PMID 15541061, PMID 15569893, PMID 15572276, PMID 15677618, PMID 15723025, PMID 15898966, PMID 15950022, PMID 15960566, PMID 16023735, PMID 16086617, PMID 16135859, PMID 16168792, PMID 16176440, PMID 16197928, PMID 16338761, PMID 16339615, PMID 16339616, PMID 16426088, PMID 16448626, PMID 16449473, PMID 16449474, PMID 16552982, PMID 16566627, PMID 16595351, PMID 16635643, PMID 16675760, PMID 16677228, PMID 16816280, PMID 16816301, PMID 16928441, PMID 17007487, PMID 17042830, PMID 17107240, PMID 17335331, PMID 17392295, PMID 17404119, PMID 17728418, PMID 17805214
2017 (2), 2025 (1), K23AA017666 (1), K24DA000435 (1), R01MH060353 (1), R01MH069801 (1), R01MH075025 (1), R01MH080097 (1), R01MH080098 (1), R01MH127531 (1), U01MH064846 (1), U01MH064850 (1), U01MH064868 (1), U01MH064869 (1), U01MH064887 (1)