164 completed, 23 terminated, 18 unknown, 12 withdrawn. 232 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 232 | Completed 164, Terminated 23, Unknown 18, Withdrawn 12, Recruiting 11, Not yet recruiting 2, Active not recruiting 1, Suspended 1 |
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 |
|---|---|---|---|---|---|---|
| Broadband Near Infrared Spectroscopy to Understand the Role of Brain Cytochrome C Oxidase in Bipolar Disorder Lurasidone (Latuda) - Bipolar Disorder Depression | Phase 4 | Not yet recruiting | Martin Lan | 60 | 2026-11-01 | 2026-09-08 |
| The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression Lumateperone 42 mg - Bipolar Depression Depressed Phase, Obesity & Overweight | Phase 4 | Recruiting | Massachusetts General Hospital | 25 | 2026-09-09 | 2026-09-11 |
| Neuromodulation of Mood Switch Circuitry in Bipolar Disorder MagVenture MagPro TMS system, Sham Stimulation - Bipolar Disorder (BD), Bipolar 1 Depression | Phase 4 | Recruiting | Weill Medical College of Cornell University | 62 | 2026-08-03 | 2026-09-23 |
| RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) Vortioxetine, Cariprazine (Augmentation Phase) - Unipolar Depression, Bipolar Depression | Phase 4 | Recruiting | Mayo Clinic | 120 | 2026-02-17 | 2026-06-22 |
| Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder Group Therapy Program, semaglutide, Phentermine-Topiramate - Bipolar I Disorder, Bipolar II Disorder | Phase 4 | Recruiting | Mayo Clinic | 100 | 2026-01-19 | 2026-03-11 |
| Dopamine D3 Receptor Occupancy in Bipolar Depression Cariprazine - Bipolar Depression | Phase 4 | Withdrawn | New York State Psychiatric Institute | 2026-01-06 | 2026-04-14 | |
| Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression repetitive transcranial magnetic stimulation, intermittent theta burst stimulation - Depression - Major Depressive Disorder, Depression Bipolar | Phase 4 | Recruiting | Region Örebro County | 350 | 2025-12-15 | 2025-12-16 |
| A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor Valbenazine - Schizophrenia, Schizoaffective Disorder | Phase 4 | Recruiting | Neurocrine Biosciences | 100 | 2025-08-29 | 2026-09-18 |
| Exercise and Olanzapine-samidorphan Olanzapine-samidorphan + exercise - Schizophenia Disorder, Schizoaffective Disorder | Phase 4 | Recruiting | New York State Psychiatric Institute | 30 | 2025-06-26 | 2026-07-13 |
| Lithium for Prevention of Cognitive Declining in Mood Illnesses Trace lithium dose plus treatment as usual, Placebo pill plus treatment as usual - Dementia, Bipolar Disorder (BD) | Phase 4 | Not yet recruiting | University of Chile | 250 | 2024-11-01 | 2024-10-30 |
| Lithium Versus Lamotrigine in Bipolar Disorder, Type II Lithium Carbonate, Lamotrigine - Bipolar II Disorder | Phase 4 | Recruiting | University Hospital Bispebjerg and Frederiksberg | 200 | 2024-05-08 | 2026-03-20 |
| Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder Sublingual film containing Igalmi - Bipolar Disorder, Schizophrenia | Phase 4 | Completed | BioXcel Therapeutics Inc | 29 | 2023-10-02 | 2026-08-11 |
| Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department Sublingual film containing dexmedetomidine (BXCL501) - Agitation, Schizophrenia | Phase 4 | Withdrawn | Brigham and Women's Hospital | 2023-09-01 | 2026-01-28 | |
| Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder Dexmedetomidine, Lorazepam 2 MG/ML - Schizophrenia Agitation, Schizo Affective Disorder | Phase 4 | Unknown | Temple University | 32 | 2023-07-01 | 2023-10-23 |
| Non-invasive BCI and Application Verification for Depressed People SSRI, rTMS, Neuro-Feedback - Depression, Major Depressive Disorder | Phase 4 | Recruiting | Shanghai Mental Health Center | 400 | 2023-07-01 | 2024-05-16 |
| Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia Valbenazine - Schizophrenia, Schizoaffective Disorder | Phase 4 | Completed | Neurocrine Biosciences | 59 | 2023-05-09 | 2026-01-16 |
| AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium Anhydrous Amiloride Hydrochloride, Placebo - Bipolar Disorder | Phase 4 | Active not recruiting | Assistance Publique - Hôpitaux de Paris | 148 | 2023-01-11 | 2025-05-09 |
| Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) Lithium, Cariprazine - Depression, Bipolar | Phase 4 | Recruiting | Aalborg University Hospital | 122 | 2022-12-13 | 2026-10-29 |
| Multi-factor Model Constraction for Early Warning and Diagnosis of MDD Omega 3 fatty acid - Major Depressive Disorder, Bipolar Disorder | Phase 4 | Unknown | Shanghai Mental Health Center | 600 | 2022-08-23 | 2022-09-07 |
| The Role of Negr1 In Modulating Neuroplasticity in Major Depression (RONIN) Venlafaxine - Major Depressive Disorder, Bipolar Affective Disorder, Currently Depressed, Moderate | Phase 4 | Unknown | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 30 | 2022-03-01 | 2023-11-14 |
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Depression (39) · Mania (27) · Schizophrenia (27) · Psychotic Disorders (26) · Depressive Disorder, Major (20) · Alcoholism (12) · Depressive Disorder (7) · Mood Disorders (6) · Substance-Related Disorders (6) · Anxiety Disorders (5) · Cognitive Dysfunction (5) · Generalized Anxiety Disorder (4) · Psychomotor Agitation (4) · Weight Gain (4)
Bipolar and Related Disorders (232) · Mental Disorders (230) · Mood Disorders (226) · Behavior (54) · Behavioral Symptoms (45) · Pathological Conditions, Signs and Symptoms (44) · Signs and Symptoms (41) · Nervous System Diseases (40) · Neurologic Manifestations (35) · Neurobehavioral Manifestations (32) · Schizophrenia Spectrum and Other Psychotic Disorders (31) · Chemically-Induced Disorders (23) · Depressive Disorder (19) · Substance-Related Disorders (17) · Alcohol-Related Disorders (12)
Lithium (27) · Olanzapine (27) · Quetiapine Fumarate (26) · Valproic Acid (22) · Lamotrigine (16) · Aripiprazole (15) · Lithium Carbonate (15) · Risperidone (13) · ziprasidone (12) · Sugars (9) · Fluoxetine (8) · Venlafaxine Hydrochloride (6) · Carbamazepine (5) · Ketamine (5) · Metformin (4)
Massachusetts General Hospital (22) · Eli Lilly and Company (11) · New York State Psychiatric Institute (10) · University of Texas Southwestern Medical Center (10) · The University of Texas Health Science Center at San Antonio (7) · Stanford University (6) · University Hospitals Cleveland Medical Center (6) · Mayo Clinic (5) · AstraZeneca (4) · Cambridge Health Alliance (4) · Federal University of Rio Grande do Sul (4) · Icahn School of Medicine at Mount Sinai (4) · Indiana University (4) · Shanghai Mental Health Center (4) · Creighton University (3)
United States (155) · Canada (10) · China (9) · Brazil (6) · South Korea (6) · Russia (5) · Australia (4) · Denmark (4) · Puerto Rico (4) · Spain (4) · Taiwan (4) · Germany (3) · Greece (3) · India (3) · Italy (3)
Janet Wozniak, MD (6) · Joseph Biederman, MD (6) · Amit Anand, MD (5) · Charles Bowden, MD (3) · Katherine Burdick, PhD (3) · Mark A Frye, MD (3) · Melissa P DelBello, MD (3) · Charles L Bowden, MD (2) · Kathleen T Brady, M.D., Ph.D. (2) · Keming Gao, MD, PhD (2) · Lori L Davis, MD (2)
PMID 21095016, PMID 28832750, PMID 10511011, PMID 10588403, PMID 10913502, PMID 11072948, PMID 15685125, PMID 17229469, PMID 17805214, PMID 17898346, PMID 18162014, PMID 18245032, PMID 18312036, PMID 18312058, PMID 18346292, PMID 18829872, PMID 19014751, PMID 19210948, PMID 19389332, PMID 19472307, PMID 19593175, PMID 19629023, PMID 19877980, PMID 19923006, PMID 20148867, PMID 20360317, PMID 20840778, PMID 21176032, PMID 21360754, PMID 21443567, PMID 21808751, PMID 21975110, PMID 22035648, PMID 22076437, PMID 22152405, PMID 22420596, PMID 22467848, PMID 22708645, PMID 22945416, PMID 22963894, PMID 22967772, PMID 23059166, PMID 23099447, PMID 23122916, PMID 23158959, PMID 23288387, PMID 23521871, PMID 23624296, PMID 23670706, PMID 23911057
R01MH060353 (2), 2016 (1), 2023 (1), K12DA000357 (1), K23AA016340 (1), K23AA017666 (1), N01MH080001 (1), P20MH068662 (1), P30MH086045 (1), R01DA021245 (1), R01DA022221 (1), R01DA022460 (1), R01MH060845 (1), R01MH061609 (1), R01MH072912 (1)