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Bipolar I Disorder
Open-data reference.
27 US clinical trials · 10 currently recruiting
Active & Recent Trials
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Xenon Pharmaceuticals
NCT07172516
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
AbbVie
NCT04777357
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Alkermes
NCT05303064
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
AbbVie
NCT06696755
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
Mayo Clinic
NCT07213466
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Vanda Pharmaceuticals
NCT05648591
Children's Bipolar Network Treatment Trial I
University of California, Los Angeles
NCT05427123
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
Medical University of South Carolina
NCT05064319
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Mclean Hospital
NCT06221852
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
Mclean Hospital
NCT05837104
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Massachusetts General Hospital
NCT06433635
ERG Components in Schizophrenia and Bipolar Disorder Type I
diaMentis
NCT03788811
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
Mclean Hospital
NCT03484494
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
BioXcel Therapeutics
NCT07116694
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
Sumitomo Pharma America
NCT01358357
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
Otsuka Pharmaceutical Development & Commercialization
NCT00094432
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
Forest Laboratories
NCT01059539
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
Sumitomo Pharma America
NCT01575561
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization
NCT03257865
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization
NCT03259555
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
AbbVie
NCT04578756
LiveWell: A Mobile Intervention for Bipolar Disorder
Northwestern University
NCT03088462
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
AbbVie
NCT06256367
The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
Mayo Clinic
NCT03156504
Sensoril(Ashwaganhda)for Bipolar Disorder
University of Pittsburgh
NCT00761761
A Study of Spoken Language in Mania
Mayo Clinic
NCT05956340
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Vanda Pharmaceuticals
NCT04127058
Phase Distribution
| Phase | Trial count |
|---|---|
| Early Phase 1 | 1 |
| Phase 2 | 4 |
| Phase 3 | 11 |
| Phase 4 | 4 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the Bipolar I Disorder Trial Landscape
ClinicalTrials.gov lists 27 US studies indexed under Bipolar I Disorder, and 10 of those are currently open to recruitment — roughly 37% 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 I Disorder shows 15 late-stage studies (Phase 3 and Phase 4 combined) alongside 5 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 I Disorder is led by AbbVie with 4 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 27 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 I Disorder?
PlainTrial tracks 27 US clinical trials for Bipolar I Disorder, of which 10 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for Bipolar I 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.
Read our methodology — how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.