Data updated: Jun 28, 2026
Bipolar Disorder Clinical Trial Landscape
Bipolar Disorder is being studied across 288 clinical trials registered since 2008, with 46 programs currently active. The competitive pipeline includes 19 active Phase 3 trials, 16 active Phase 2 trials, and 4 active Phase 1 trials.
Top industry sponsors include Intra-Cellular Therapies, Inc., Bristol-Myers Squibb, Xenon Pharmaceuticals Inc..
Trial activity
46 active / 288 total since 2008
Active by phase 19 Ph3 / 96 16 Ph2 / 74 4 Ph1 / 34 7 Ph4 / 84
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
Sorted by active Active Done Failed
Intra-Cellular Therapies, Inc. 4 4 0
Bristol-Myers Squibb 3 0 0
Xenon Pharmaceuticals Inc. 2 0 0
Eli Lilly 1 3 0
BioXcel Therapeutics Inc 1 2 0
Neurocrine Biosciences 1 1 0
Autobahn Therapeutics, Inc. 1 0 0
Alto Neuroscience 1 0 0
Neurocentrx Pharma Pty Ltd 1 0 0
AstraZeneca 0 8 0
Sumitomo Pharma America, Inc. 0 6 0
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 0 0 5
GSK 0 4 1
Forest Laboratories 0 4 0
Otsuka Pharmaceutical Development & Commercialization, Inc. 0 3 0
How the field has grown
New-trial starts peaked in 2017 (16 registered); 2025 saw 16. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (37 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.
New trials started by year
2016 12
2017 16
2018 10
2019 7
2020 5
2021 8
2022 10
2023 13
2024 15
2025 16
2026 7
TheraRadar.com
Median Phase 3 enrollment by start year
2016 (7) 265
2017 (3) 100
2018 (3) 23
2019 (0) 0
2020 (2) 434
2021 (3) 63
2022 (1) 74
2023 (1) 360
2024 (7) 350
2025 (8) 409
2026 (2) 75
TheraRadar.com
Full trial pipeline
Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.
NCT06929273 RECRUITING
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bristol-Myers Squibb n=450
NCT07172516 RECRUITING
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Xenon Pharmaceuticals Inc. n=400
NCT07140913 RECRUITING
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
Bristol-Myers Squibb n=424
NCT06951711 RECRUITING
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bristol-Myers Squibb n=274
NCT05054699 ACTIVE NOT RECRUITING
Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study
University of Sao Paulo n=100
NCT07263022 NOT YET RECRUITING
Cognitive Strategies in Early Psychosis 2
University of Minnesota n=24
NCT07217860 ENROLLING BY INVITATION
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Xenon Pharmaceuticals Inc. n=400
NCT06986460 RECRUITING
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Tyler Kaster n=80
NCT05603104 RECRUITING
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
Dr. Inge Winter n=1,254
NCT05973786 RECRUITING
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.
Dr. Inge Winter n=418
NCT06529029 RECRUITING
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Michigan State University n=30
NCT06372964 RECRUITING
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Intra-Cellular Therapies, Inc. n=384
NCT06229210 RECRUITING
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Intra-Cellular Therapies, Inc. n=500
NCT06462612 RECRUITING
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
Intra-Cellular Therapies, Inc. n=350
NCT06462586 RECRUITING
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Intra-Cellular Therapies, Inc. n=350
NCT05867849 RECRUITING
Cannabidiol for Bipolar Depression (CBD-BD)
University of British Columbia n=360
NCT04569448 RECRUITING
Brexpiprazole Treatment for Bipolar I Depression
Douglas Mental Health University Institute n=58
NCT05625555 ACTIVE NOT RECRUITING
Predictors of Intravenous Ketamine Response in TRD
Abraham Nunes n=40
NCT07664852 NOT YET RECRUITING
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Daniel Lindqvist n=126
NCT02600494 COMPLETED
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Intra-Cellular Therapies, Inc. n=554
NCT04285515 COMPLETED
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Intra-Cellular Therapies, Inc. n=488
NCT02731612 COMPLETED
Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients
Lakshmi N Yatham n=100
NCT04939649 COMPLETED
Ketamine As an Adjunctive Therapy for Major Depression (2)
University of Dublin, Trinity College n=63
NCT01737268 COMPLETED
Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Astellas Pharma Inc n=20
NCT02362412 COMPLETED
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Astellas Pharma Inc n=22
NCT01725308 COMPLETED
A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Astellas Pharma Inc n=431
NCT02918370 COMPLETED
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
University of Texas Southwestern Medical Center n=75
NCT01244815 COMPLETED
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Organon and Co n=404
NCT01349907 COMPLETED
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
Organon and Co n=322
NCT03395392 COMPLETED
NRX-101 for Bipolar Depression With Subacute Suicidal Ideation
NeuroRx, Inc. n=74
NCT01928446 TERMINATED
Lithium for Suicidal Behavior in Mood Disorders
VA Office of Research and Development n=519
NCT04276883 COMPLETED
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
BioXcel Therapeutics Inc n=380
NCT03674671 SUSPENDED
Ketamine Versus Electroconvulsive Therapy in Depression
University of Ottawa n=240
NCT02600507 COMPLETED
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Intra-Cellular Therapies, Inc. n=529
NCT02800161 COMPLETED
Trehalose as add-on Therapy in Bipolar Depression
Consorcio Centro de Investigación Biomédica en Red (CIBER) n=60
NCT03249376 COMPLETED
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Intra-Cellular Therapies, Inc. n=381
NCT01986101 COMPLETED
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Sumitomo Pharma Co., Ltd. n=525
NCT02726659 TERMINATED
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's n=1
NCT03310593 TERMINATED
Cannabidiol as an Adjunctive Treatment for Bipolar Depression
Hospital de Clinicas de Porto Alegre n=36
NCT03768726 TERMINATED
Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. n=23
NCT02075047 TERMINATED
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. n=171
NCT01113541 TERMINATED
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. n=13
NCT01124877 WITHDRAWN
Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
NCT01117220 WITHDRAWN
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
NCT02519543 COMPLETED
Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder
Cynthia Calkin n=50
NCT00575328 TERMINATED
Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females
Massachusetts General Hospital n=8
NCT01934972 COMPLETED
A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder
University of Arizona n=30
NCT02703363 COMPLETED
Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression
Pakistan Institute of Living and Learning n=265
NCT02670538 COMPLETED
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
Forest Laboratories n=493
NCT02670551 COMPLETED
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
Forest Laboratories n=488
NCT01372722 WITHDRAWN
Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder
University Hospital, Bonn
NCT00914680 COMPLETED
Berlin Magnetic Seizure Therapy Depression Trial 01
Charite University, Berlin, Germany n=32
NCT01429272 COMPLETED
Minocycline and Aspirin in the Treatment of Bipolar Depression
Laureate Institute for Brain Research, Inc. n=99
NCT02308956 COMPLETED
Task Sharing for the Care of Severe Mental Disorders in a Low-income Country
University of Cape Town n=324
NCT01979133 COMPLETED
Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
University of Texas Southwestern Medical Center n=10
NCT00566020 COMPLETED
A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -
GlaxoSmithKline n=92
NCT01504659 TERMINATED
Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
Juvenile Bipolar Research Foundation n=5
NCT00723450 COMPLETED
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
GlaxoSmithKline n=301
NCT00671853 COMPLETED
Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
University Hospitals Cleveland Medical Center n=120
NCT01403662 COMPLETED
Evaluating the Efficacy of Adjunctive Minocycline for the Treatment of Bipolar Depression
University Health Network, Toronto n=29
NCT00852592 COMPLETED
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
Northwestern University n=46
NCT01467713 TERMINATED
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
Takeda n=642
NCT02423824 COMPLETED
Cognitive Dysfunction and Glucagon-like Peptide-1 Agonists
University Health Network, Toronto n=21
NCT01256177 COMPLETED
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
AstraZeneca n=361
NCT00868959 COMPLETED
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Sumitomo Pharma America, Inc. n=817
NCT01677182 TERMINATED
Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
Takeda n=535
NCT01562184 COMPLETED
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
The University of New South Wales n=120
NCT01093963 TERMINATED
Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression
Lindner Center of HOPE n=25
NCT01586793 COMPLETED
Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression
Douglas Mental Health University Institute n=8
NCT00621842 COMPLETED
Lamotrigine for Symptoms of Geriatric Bipolar Depression
University Hospitals Cleveland Medical Center n=57
NCT00499096 COMPLETED
Self-Management Addressing Heart Disease Risk Trial
US Department of Veterans Affairs n=118
NCT01520350 TERMINATED
Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study
Serge Beaulieu n=2
NCT00817323 WITHDRAWN
What is the Antidepressant Mechanism of Action of Quetiapine in Bipolar Depression?
University of British Columbia
NCT00868452 COMPLETED
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
Sumitomo Pharma America, Inc. n=348
NCT00868699 COMPLETED
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Sumitomo Pharma America, Inc. n=505
NCT00665366 COMPLETED
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc. n=493
NCT01284517 COMPLETED
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Sumitomo Pharma America, Inc. n=356
NCT01166425 COMPLETED
Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) n=81
NCT00993850 COMPLETED
Sleep Disturbance and Bipolar Disorder
University of California, Berkeley n=52
NCT01685151 WITHDRAWN
A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder
Takeda
NCT01197846 COMPLETED
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder
Centro de Investigación Biomédica en Red de Salud Mental n=28
NCT00713804 COMPLETED
Impact of Genetic Counseling for Individuals With Mental Illness
University of British Columbia n=120
NCT00883493 COMPLETED
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
AstraZeneca n=421
NCT00857584 COMPLETED
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
AstraZeneca n=27
NCT00714818 COMPLETED
Impact of Genetic Counseling for Female First Degree Relatives of Individuals With Mental Illness
University of British Columbia n=13
NCT00763230 COMPLETED
A Study of Transcranial Direct Current Stimulation (tDCS) to Treat Depression
The University of New South Wales n=68
Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only