Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

ClinicalTrials.gov 37 recruiting now official registry

Bipolar Disorder clinical trials

Every US clinical trial registered for Bipolar Disorder — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

163 US clinical trials · 37 currently recruiting

The research picture

Bipolar Disorder has 163 registered US clinical trials, 37 of them open to new participants right now — about 23% of the total.

37
recruiting participants now
23%
of trials open to enrollment
45
in Phase 3–4 (later-stage)
11
top sponsor: Massachusetts General Hospital

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING 16,000 participants

Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

National Institute of Mental Health (NIMH)

NCT00024635

RECRUITING 1,260 participants

NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder

National Institute of Mental Health (NIMH)

NCT05669703

RECRUITING 1,000 participants

University of Iowa Interventional Psychiatry Service Patient Registry

Mark Niciu

NCT04480918

RECRUITING NA 600 participants

Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations

Massachusetts General Hospital

NCT04296604

RECRUITING Phase 3 500 participants

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Intra-Cellular Therapies

NCT06229210

RECRUITING Phase 3 424 participants

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

NCT07140913

RECRUITING Phase 2 400 participants

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Eli Lilly and Company

NCT07286175

RECRUITING Phase 3 400 participants

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Xenon Pharmaceuticals

NCT07172516

RECRUITING NA 350 participants

Enhanced Coordinated Specialty Care for Early Psychosis

Mclean Hospital

NCT06071858

RECRUITING NA 300 participants

Taking Action for College Students

Temple University

NCT06700902

RECRUITING 200 participants

mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders

VA Office of Research and Development

NCT06204705

RECRUITING NA 200 participants

Cerebellar Stimulation and Cognitive Control

Krystal Parker, PhD

NCT03217110

RECRUITING 200 participants

Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study

Mayo Clinic

NCT06897670

RECRUITING NA 190 participants

CBT-CP for Veterans With SMI

VA Office of Research and Development

NCT06758414

RECRUITING NA 150 participants

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

University of California, Berkeley

NCT06555406

RECRUITING NA 136 participants

Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder

Massachusetts General Hospital

NCT06274567

RECRUITING NA 120 participants

Early Intervention for Youth at High Risk for Bipolar Disorder

University of Pittsburgh

NCT04815239

RECRUITING NA 111 participants

Reduction of Anticholinergic Medications Among Persons With Schizophrenia or Other Psychiatric Disorders

University of Pittsburgh

NCT07043803

RECRUITING NA 107 participants

Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

University of Pittsburgh

NCT06081426

RECRUITING 100 participants

Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder

University Hospitals Cleveland Medical Center

NCT03829787

RECRUITING NA 100 participants

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Stony Brook University

NCT06373016

RECRUITING NA 100 participants

Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study

University of Texas at Austin

NCT05838274

RECRUITING NA 100 participants

Personalized Mobile Cognitive Behavioral Therapy Application

Weill Medical College of Cornell University

NCT05699525

RECRUITING NA 84 participants

Visual Perception in Schizophrenia

University of Rochester

NCT06911931

RECRUITING NA 80 participants

Enhancing Rehabilitation for Veterans With Serious Mental Illness

VA Office of Research and Development

NCT06586164

RECRUITING 80 participants

Children's Bipolar Network Treatment Trial I

University of California, Los Angeles

NCT05427123

RECRUITING NA 70 participants

A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

Massachusetts General Hospital

NCT06609902

RECRUITING Phase 2 68 participants

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

Medical University of South Carolina

NCT05064319

RECRUITING NA 60 participants

Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)

Joao L. DeQuevedo

NCT04080778

RECRUITING NA 52 participants

Getting Out of the House: Using Behavioral Activation to Increase Community Participation

Temple University

NCT06336616

RECRUITING Phase 2 50 participants

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Leslie Swanson

NCT06226025

RECRUITING Phase 4 50 participants

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

Neurocrine Biosciences

NCT07105111

RECRUITING Phase 2 30 participants

The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects

Yale University

NCT05786066

RECRUITING Phase 2 30 participants

BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study

Massachusetts General Hospital

NCT02481245

RECRUITING Phase 2 30 participants

Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy

Michigan State University

NCT06529029

RECRUITING Phase 2 25 participants

Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Mclean Hospital

NCT05457465

RECRUITING NA 20 participants

Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness

VA Office of Research and Development

NCT05491538

ACTIVE NOT RECRUITING 6,000 participants

Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression

University of Texas Southwestern Medical Center

NCT06002204

ACTIVE NOT RECRUITING 4,185 participants

Evaluation of the Genetics of Bipolar Disorder

National Institute of Mental Health (NIMH)

NCT00001174

ACTIVE NOT RECRUITING NA 190 participants

Effectiveness RCT of Customized Adherence Enhancement

Case Western Reserve University

NCT04622150

ACTIVE NOT RECRUITING NA 176 participants

Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders

Case Western Reserve University

NCT04675593

ACTIVE NOT RECRUITING 120 participants

Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

Brigham and Women's Hospital

NCT03336918

ACTIVE NOT RECRUITING 120 participants

Imaging mGluR5 and Synaptic Density in Psychiatric Disorders

Yale University

NCT03898297

ACTIVE NOT RECRUITING NA 40 participants

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Mclean Hospital

NCT03484494

ACTIVE NOT RECRUITING NA 8 participants

Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)

National Institute of Mental Health (NIMH)

NCT05172271

COMPLETED NA 2,443 participants

Person-Centered Versus Measurement-Based Care in Mental Health

University of Pittsburgh

NCT02507349

COMPLETED 1,303 participants

Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study

National Institute of Mental Health (NIMH)

NCT00006177

COMPLETED Phase 4 1,270 participants

A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Otsuka Pharmaceutical Development & Commercialization

NCT00261443

COMPLETED Phase 3 1,255 participants

Quetiapine Fumarate Bipolar Maintenance Monotherapy

AstraZeneca

NCT00314184

COMPLETED Phase 4 1,169 participants

A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

Otsuka Pharmaceutical Development & Commercialization

NCT00277212

COMPLETED Phase 3 676 participants

Seroquel in Bipolar Depression Versus SSRI

AstraZeneca

NCT00119652

COMPLETED Phase 3 488 participants

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

Forest Laboratories

NCT02670551

COMPLETED Phase 3 434 participants

Study Evaluating Bifeprunox in Bipolar Depression

Wyeth is now a wholly owned subsidiary of Pfizer

NCT00134459

COMPLETED NA 384 participants

Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites

University of Michigan

NCT00747201

COMPLETED Phase 3 380 participants

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

BioXcel Therapeutics

NCT04276883

COMPLETED Phase 3 379 participants

Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

Washington University School of Medicine

NCT00057681

COMPLETED Phase 3 343 participants

Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Novartis Pharmaceuticals

NCT00107926

COMPLETED Phase 4 340 participants

Optimizing Electroconvulsive Therapy for Depression

New York State Psychiatric Institute

NCT00045916

COMPLETED Phase 3 301 participants

Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients

GlaxoSmithKline

NCT00723450

COMPLETED 300 participants

A Study of Pregnant and Postpartum Women With and Without Mood Disorders

Johns Hopkins University

NCT03615794

COMPLETED NA 292 participants

Early Detection and Intervention for the Prevention of Psychosis

MaineHealth

NCT00531518

COMPLETED NA 291 participants

Implementation Trial of Evidence Based Practices for Mood Disorders

University of Arkansas

NCT02150577

COMPLETED NA 240 participants

The Appeal and Impact of E-cigarettes in Smokers With SMI

Dartmouth-Hitchcock Medical Center

NCT03050853

COMPLETED Phase 4 224 participants

Treatment of Bipolar Mania in Older Adults

Weill Medical College of Cornell University

NCT00254488

COMPLETED 224 participants

A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder

Janssen Research & Development

NCT03017781

COMPLETED Phase 3 220 participants

Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.

Hadassah Medical Organization

NCT00158990

COMPLETED NA 205 participants

LiveWell: A Mobile Intervention for Bipolar Disorder

Northwestern University

NCT03088462

COMPLETED Phase 4 181 participants

Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Novartis

NCT00139594

COMPLETED NA 180 participants

Examination of Glutamate and mGluR5 in Psychiatric Disorders

Yale University

NCT02727972

COMPLETED NA 174 participants

Comparing Mobile Health (mHealth) and Clinic-Based Self-Management Interventions for Serious Mental Illness

Dartmouth-Hitchcock Medical Center

NCT02421965

COMPLETED Phase 2 168 participants

Supported Employment: Motivational Enhancement for Entry and Outcome

VA Office of Research and Development

NCT01041976

COMPLETED NA 168 participants

Virtual Reality Job Interview Training in Severe Mental Illness

University of Michigan

NCT03049813

COMPLETED Phase 1 152 participants

Valproate Efficacy in Cocaine-Bipolar Comorbidity

University of Miami

NCT00240110

COMPLETED 150 participants

The Evaluation and Follow-up of Patients With Bipolar Disorder

National Institute of Mental Health (NIMH)

NCT00001652

COMPLETED Phase 3 150 participants

An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

Abbott

NCT00067262

COMPLETED 139 participants

The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

NYU Langone Health

NCT03166098

COMPLETED NA 123 participants

Contingency Management of Alcohol Abuse in the Severely Mentally ILL

University of Washington

NCT01567943

COMPLETED Phase 3 120 participants

Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)

University Hospitals Cleveland Medical Center

NCT00671853

COMPLETED NA 120 participants

Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI

Dartmouth-Hitchcock Medical Center

NCT02334280

COMPLETED 118 participants

Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Massachusetts General Hospital

NCT00580268

COMPLETED Phase 3 118 participants

Self-Management Addressing Heart Disease Risk Trial

US Department of Veterans Affairs

NCT00499096

COMPLETED Phase 4 115 participants

Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence

University of Texas Southwestern Medical Center

NCT00223249

COMPLETED NA 108 participants

Family Intervention for Mental Illness and Substance Abuse

Dartmouth-Hitchcock Medical Center

NCT00043693

COMPLETED 107 participants

Brain Imaging in Depression

National Institute of Mental Health (NIMH)

NCT00050700

COMPLETED Phase 4 103 participants

Targeting Cognition in Bipolar Disorder With Pramipexole

Brigham and Women's Hospital

NCT02397837

COMPLETED Phase 3 102 participants

Acute Treatment of Bipolar II Depression

Stanford University

NCT00074776

COMPLETED 102 participants

Bipolar Disorder in Epilepsy

Northwell Health

NCT00365482

COMPLETED NA 90 participants

Development of a Personalized Real-time Intervention for Bipolar Disorder

University of California, San Diego

NCT01670123

COMPLETED NA 88 participants

Pilot Trial of Peer Support for Bipolar Disorder

Kaiser Permanente

NCT02404246

COMPLETED NA 87 participants

Mobile Self-Tracking of Mental Health

VA Office of Research and Development

NCT05023252

COMPLETED 80 participants

Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers

Johns Hopkins University

NCT03638687

COMPLETED NA 78 participants

Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI

University of California, San Diego

NCT03198364

COMPLETED Phase 3 75 participants

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

University of Texas Southwestern Medical Center

NCT02918370

COMPLETED Phase 3 75 participants

Treatment of Mania Symptoms With Drug Therapy

Palo Alto Veterans Institute for Research

NCT00183443

COMPLETED Phase 4 75 participants

Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania

University of Cincinnati

NCT00393978

COMPLETED NA 65 participants

Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms

Yale University

NCT05317481

COMPLETED NA 65 participants

Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder

University of Rochester

NCT00252486

COMPLETED NA 62 participants

Uridine Adolescent Bipolar Depression Randomized Controlled Trial

University of Utah

NCT01805440

COMPLETED Phase 3 60 participants

Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

University Hospitals Cleveland Medical Center

NCT00194077

COMPLETED Phase 4 60 participants

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

University of Pittsburgh

NCT00177567

Phase Distribution

PhaseTrial count
Phase 1 3
Phase 2 12
Phase 3 23
Phase 4 22

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Bipolar Disorder Trial Landscape

ClinicalTrials.gov lists 163 US studies indexed under Bipolar Disorder, and 37 of those are currently open to recruitment — roughly 23% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Bipolar Disorder shows 45 late-stage studies (Phase 3 and Phase 4 combined) alongside 15 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Bipolar Disorder is led by Massachusetts General Hospital with 11 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 100 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Bipolar Disorder?

PlainTrial tracks 163 US clinical trials for Bipolar Disorder, of which 37 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Bipolar Disorder?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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