21 completed, 8 recruiting, 6 unknown, 4 active not recruiting. 15 Phase 2, 12 Not applicable, 6 Phase 3, 6 Phase 4, 1 Early Phase 1.
Follow Bipolar II Disorder: new trials by email Literature Review of Bipolar II Disorder trials Research Report on Bipolar II 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 |
|---|---|---|---|---|---|---|
| Digital Phenotypes for Predicting Depression_Validation Major Depressive Disorder, Bipolar I Disorder | Enrolling by invitation | Korea University Anam Hospital | 200 | 2026-05-13 | 2026-10-19 | |
| A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder Icalcaprant, Placebo for Icalcaprant - Bipolar I Disorder, Bipolar II Disorder | Phase 2 | Recruiting | AbbVie | 195 | 2026-02-03 | 2026-08-14 |
| 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 |
| 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 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 |
| Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression Device: Stimulation-ON, Device: Stimulation-OFF, Device: Stimulation -ON Active Control - Bipolar II Disorder, Bipolar II Disorder, Most Recent Episode Major Depressive | Not applicable | Recruiting | Andrew Krystal | 10 | 2025-07-16 | 2025-08-17 |
| SYNCED - SYNChronized Eating in Bipolar Depression Study Time restricted eating, Eating ad libitum with nutritional counselling - Bipolar Depression, Bipolar I Disorder | Not applicable | Recruiting | University of Ottawa | 40 | 2025-07-10 | 2026-05-01 |
| Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality Psilocybin, Therapeutic Support - Bipolar II Disorder, Depression, Bipolar | Phase 2 | Recruiting | The University of Texas Health Science Center, Houston | 10 | 2025-07-07 | 2026-08-12 |
| Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder BXCL501 Sublingual Film - Bipolar I Disorder, Bipolar II Disorder | Phase 2 | Completed | BioXcel Therapeutics Inc | 33 | 2025-06-19 | 2026-10-05 |
| 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 | |
| Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder ABBV-932, Placebo for ABBV-932 - Bipolar I Disorder, Bipolar II Disorder | Phase 2 | Completed | AbbVie | 161 | 2024-10-15 | 2026-10-14 |
| 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 |
| 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 |
| Phase 2 Clinical Trial of GH001 in Bipolar II Disorder GH001 - Bipolar II Disorder | Phase 2 | Terminated | GH Research Ireland Limited | 6 | 2023-04-06 | 2025-02-18 |
| Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness LCHF Ketogenic Diet - Bipolar Disorder I, Bipolar II Disorder | Not applicable | Unknown | Stanford University | 30 | 2023-01-30 | 2023-01-30 |
| 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 |
| Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression Aerobic Physical Exercise, Relaxing Physical Exercise, Information about physical exercise - Bipolar Disorder, Bipolar Depression | Not applicable | Suspended | Region Stockholm | 54 | 2022-10-26 | 2026-02-10 |
| Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression Ketamine Hydrochloride - Bipolar Disorder, Bipolar Depression | Phase 2 | Completed | Joshua Rosenblat | 41 | 2022-08-11 | 2026-03-05 |
| Ketamine for Treatment-Resistant Bipolar Disorder Ketamine Hydrochloride, Midazolam Hydrochloride - Bipolar Disorder, Bipolar Depression | Phase 2 | Completed | Joshua Rosenblat | 71 | 2022-07-04 | 2026-03-05 |
| Children's Bipolar Network Treatment Trial I Medication or psychosocial treatment - Bipolar Disorder, Bipolar I Disorder | Recruiting | University of California, Los Angeles | 80 | 2022-07-01 | 2026-02-05 |
Showing 20 of 45. Sign in to see all of them.
Bipolar Disorder (45) · Depression (9) · Depressive Disorder, Major (8) · Psychotic Disorders (7) · Schizophrenia (5) · Mental Disorders (4) · Mood Disorders (4) · Suicidal Ideation (4) · Depressive Disorder (2) · Lymphoma, Follicular (2) · Mania (2) · Motor Activity (2) · Obesity (2) · Psychomotor Agitation (2) · Substance-Related Disorders (2)
Bipolar and Related Disorders (44) · Mental Disorders (41) · Mood Disorders (41) · Behavior (17) · Behavioral Symptoms (13) · Pathological Conditions, Signs and Symptoms (7) · Schizophrenia Spectrum and Other Psychotic Disorders (7) · Signs and Symptoms (7) · Depressive Disorder (6) · Nervous System Diseases (5) · Neurobehavioral Manifestations (4) · Neurologic Manifestations (4) · Self-Injurious Behavior (4) · Body Weight (3) · Body Weight Changes (3)
Ketamine (5) · Quetiapine Fumarate (3) · Dexmedetomidine (2) · Gabapentin (2) · Lamotrigine (2) · Lithium Carbonate (2) · Midazolam (2) · Therapeutics (2) · Acetylcysteine (1) · Ashwagandha (1) · Circadian Rhythm (1) · Cognitive Behavioral Therapy (1) · Dextroamphetamine (1) · Dosage Forms (1) · Exercise (1)
Medical University of South Carolina (3) · AbbVie (2) · BioXcel Therapeutics Inc (2) · Centre for Addiction and Mental Health (2) · Joshua Rosenblat (2) · Mayo Clinic (2) · Stanford University (2) · University of Pittsburgh (2) · Xenon Pharmaceuticals Inc. (2) · Andrew Krystal (1) · Community Health Center, Inc. (1) · Ege University (1) · GH Research Ireland Limited (1) · Hospital de Clinicas de Porto Alegre (1) · Hucircadian (1)
United States (27) · Canada (6) · Germany (2) · South Korea (2) · United Kingdom (2) · Belgium (1) · Brazil (1) · Bulgaria (1) · Denmark (1) · France (1) · Hong Kong (1) · Japan (1) · Netherlands (1) · Puerto Rico (1) · Spain (1)
BioXcel MM (2) · James J Prisciandaro, PhD (2) · Joshua Rosenblat, MD, MSc (2) · Ana P Anzolin, Master (1) · Andrew Krystal, MD, MS (1) · Charles L. Bowden, M.D. (1) · Daniel Blumberger, MD, MSc (1) · David G Harper, PhD (1) · David Guard, PhD (1) · David Guggenheim, PsyD (1) · David J Miklowitz, PhD (1) · Ellen Scotton, Master (1) · Gayatri Saraf, MD (1) · Harry Lando, PhD (1)
PMID 22117393, PMID 22420597, PMID 23521871, PMID 24330893, PMID 24377402, PMID 31752508, PMID 32306747, PMID 32773576, PMID 33593332, PMID 34131914, PMID 34390300, PMID 34523118, PMID 35503059, PMID 36970275, PMID 38142892, PMID 38479192, PMID 38688118, PMID 39086163, PMID 41401709, PMID 41864720, PMID 42103384, PMID 42442821, PMID 42684694, PMID 42702010, PMID 42765891
2023 (1), P30MH086045 (1), R01DA054275 (1)