114 completed, 21 recruiting, 19 unknown, 17 terminated. 57 Not applicable, 44 Phase 3, 41 Phase 2, 27 Phase 4, 12 Phase 1.
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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 |
|---|---|---|---|---|---|---|
| Safety and Feasibility of DBS for Bipolar Depression Medtronic Percept PC DBS system - Bipolar I Disorder, Bipolar Depression | Not applicable | Recruiting | Icahn School of Medicine at Mount Sinai | 5 | 2026-09-21 | 2026-09-22 |
| PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder Nutritional intervention - Bipolar Depression, Bipolar Disorder (BD) | Not applicable | Recruiting | University of Sao Paulo | 88 | 2026-04-01 | 2026-03-02 |
| Empagliflozin Adjunctive Therapy in Bipolar Depression Empagliflozin (EMPA) - Bipolar Disorder, Bipolar Depression | Not applicable | Not yet recruiting | University of Sao Paulo | 20 | 2026-03-09 | 2026-03-16 |
| 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 |
| Dopamine D3 Receptor Occupancy in Bipolar Depression Cariprazine - Bipolar Depression | Phase 4 | Withdrawn | New York State Psychiatric Institute | 2026-01-06 | 2026-04-14 | |
| EEG Microstate and Neuroinflammatory Biomarkers in Older Age Patients With Major Depressive Disorder Receiving ECT Electroconvulsive Therapy - Major Depression Moderate, Major Depression Severe | Recruiting | Istanbul University - Cerrahpasa | 62 | 2025-12-01 | 2026-07-31 | |
| 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 |
| HD-tDCS for Adolescent Bipolar Depression Targeting S1 Active HD-tDCS, Antipsychotics, mood stabilizers, etc., Sham HD-tDCS - Adolescent, Bipolar Depression | Not applicable | Recruiting | Jiangsu Province Nanjing Brain Hospital | 100 | 2025-09-16 | 2025-11-24 |
| Ketogenic Intervention for Bipolar Depression Ketogenic Diet - Bipolar Depression | Not applicable | Recruiting | Mayo Clinic | 30 | 2025-08-12 | 2026-08-17 |
| 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 |
| 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 |
| Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression ExAblate Neuro 4000 - Treatment-Resistant Depression, Bipolar Depression | Not applicable | Recruiting | Sunnybrook Health Sciences Centre | 10 | 2025-06-25 | 2025-08-06 |
| Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression Temporal Interference Stimulation, Sham Temporal Interference Stimulation - Bipolar Depression | Not applicable | Recruiting | First Affiliated Hospital of Zhejiang University | 160 | 2025-05-20 | 2026-05-27 |
| Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure Clozapine, Esketamine Nasal Product, Escitalopram - Schizophrenia and Related Disorders, Major Depressive Disorder | Phase 3 | Recruiting | Dr. Inge Winter | 1254 | 2025-04-27 | 2026-01-22 |
| The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. Escitalopram, Sertraline, Venlafaxine - Bipolar Depression | Phase 3 | Recruiting | Dr. Inge Winter | 418 | 2025-02-11 | 2025-09-26 |
| Deep Brain Stimulation of Treatment-Resistant Bipolar Depression Medtronic Percept RC System, One Month Blinded Discontinuation Period - Bipolar Depression | Not applicable | Recruiting | Wayne Goodman MD | 10 | 2025-01-01 | 2026-01-26 |
| FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression Ketamine, Functional magnetic resonance imaging (fMRI) - Bipolar Depression, Treatment Resistant Bipolar Depression | Phase 2 | Completed | Drew Cumming | 20 | 2024-11-12 | 2026-10-15 |
| Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression Psilocybin, Functional MRI - Bipolar Depression | Phase 1 | Active not recruiting | University Health Network, Toronto | 30 | 2024-10-09 | 2026-08-10 |
| Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression deep Transcranial Magnetic Stimulation (dTMS) -active, deep Transcranial Magnetic Stimulation (dTMS) -sham - Bipolar Depression | Not applicable | Recruiting | Tianjin Anding Hospital | 100 | 2024-08-01 | 2026-02-27 |
| Task-State-Based Temporal Interference Stimulation (TI) to Improve Depression in Patients With Bipolar Disorder Temporal Interference Stimulation - Bipolar Depression | Not applicable | Completed | First Affiliated Hospital of Zhejiang University | 36 | 2024-07-16 | 2026-05-27 |
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Bipolar Disorder (190) · Depression (61) · Depressive Disorder, Major (26) · Depressive Disorder (19) · Depressive Disorder, Treatment-Resistant (12) · Mood Disorders (10) · Suicidal Ideation (10) · Anxiety Disorders (3) · Cognitive Dysfunction (2) · Inflammation (2) · Insulin Resistance (2) · Mania (2) · Mental Disorders (2) · Metabolic Syndrome (2) · Schizophrenia (2)
Bipolar and Related Disorders (189) · Mental Disorders (188) · Mood Disorders (180) · Behavior (69) · Behavioral Symptoms (68) · Depressive Disorder (29) · Self-Injurious Behavior (11) · Pathological Conditions, Signs and Symptoms (9) · Suicide (9) · Nervous System Diseases (7) · Signs and Symptoms (7) · Neurologic Manifestations (6) · Metabolic Diseases (4) · Neurobehavioral Manifestations (4) · Nutritional and Metabolic Diseases (4)
Ketamine (16) · Lurasidone Hydrochloride (12) · Quetiapine Fumarate (10) · Lithium (9) · Lamotrigine (6) · Transcranial Magnetic Stimulation (5) · Valproic Acid (5) · lumateperone (5) · Escitalopram (4) · Midazolam (4) · Minocycline (4) · Therapeutics (4) · Ultraviolet Therapy (4) · Sertraline (3) · cariprazine (3)
Mclean Hospital (12) · AstraZeneca (9) · Intra-Cellular Therapies, Inc. (5) · Massachusetts General Hospital (5) · Mayo Clinic (5) · NeuroRx, Inc. (5) · Sumitomo Pharma America, Inc. (5) · University of Sao Paulo (5) · Centre for Addiction and Mental Health (4) · New York State Psychiatric Institute (4) · University Health Network, Toronto (4) · First Affiliated Hospital of Zhejiang University (3) · Indiana University (3) · Medical University of South Carolina (3) · National Institute of Mental Health (NIMH) (3)
United States (102) · Canada (28) · Russia (10) · Ukraine (10) · China (9) · Spain (9) · Brazil (7) · Colombia (7) · France (6) · Germany (6) · India (6) · Poland (6) · Serbia (6) · South Korea (6) · Bulgaria (5)
Amit Anand, MD (4) · Susan Kozauer, MD (4) · Joshua Rosenblat, MD, MSc (3) · Martin Brecher, MD (3) · Andrew Nierenberg, MD (2) · Beth L Murphy, MD, PhD (2) · Brent P Forester, MD (2) · Daniel Blumberger, MD, MSc (2) · Declan M McLoughlin, PhD (2) · Gregory Sahlem, MD (2) · Lori L Davis, MD (2) · Mark Frye, MD (2) · Nassir Ghaemi, MD, MPH (2)
PMID 41017591, PMID 14702256, PMID 20854181, PMID 26730454, PMID 27215976, PMID 27529375, PMID 34510411, PMID 37339360, PMID 39098761, PMID 41401709, PMID 15780843, PMID 17229469, PMID 19956089, PMID 20074703, PMID 20122366, PMID 20122369, PMID 20136801, PMID 21034692, PMID 21808751, PMID 22545088, PMID 22827578, PMID 23059166, PMID 23364679, PMID 24170180, PMID 24170221, PMID 24331545, PMID 24699040, PMID 24715548, PMID 25340384, PMID 25522399, PMID 25721187, PMID 25844756, PMID 26363720, PMID 26911380, PMID 27089521, PMID 27366831, PMID 28706563, PMID 29111077, PMID 29146409, PMID 29673379, PMID 30102967, PMID 30172724, PMID 30184133, PMID 30466205, PMID 30524702, PMID 31066887, PMID 31630035, PMID 31923551, PMID 31969269, PMID 32055965
2016 (2), 1UH3NS136631 (1), 2018 (1), 2019 (1), 2023 (1), K23MH077287 (1), R01MH078060 (1), R01MH079261 (1), R01MH090276 (1), T32DA022975 (1)