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Bipolar I Disorder: later-stage trial registry
10 of 27 indexed Bipolar I Disorder trials are currently recruiting, with more weight in Phase 3-4.
Corpus placement: #598 of 28,707 conditions by registered trial count.
27 US clinical trials · 10 currently recruiting · #598 of 28,707 conditions by registered trial count
Bipolar I Disorder: 27 US clinical trials tracked, 10 recruiting.
Bipolar I Disorder is the subject of 27 registered US clinical trials on ClinicalTrials.gov, 10 of them currently open to new participants. 15 are in Phase 3-4 (later-stage) and 5 in Phase 1-2 (earlier-stage). The most active sponsor is AbbVie, running 4 of these trials.
Enrollment posture brief
Registry condition bipolar-i-disorder
OPEN 10 | RECR 37% | LATE 15 | EARLY 5 | RANK #598 | SPON 4
Volume-matched condition peers
Nearest open-share peer: Liver Cancer (37% recruiting · 81 trials)
Bipolar I Disorder lists 10 open slots (37% of 27 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →
Key findings
What ClinicalTrials.gov does not surface for Bipolar I Disorder on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.
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Bipolar I Disorder is recruiting below its size-band peers.
10 of 27 indexed trials (37%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.
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Sponsorship of Bipolar I Disorder trials is spread across many organizations.
AbbVie accounts for 4 of 27 trials (14.8%). 16 distinct sponsors appear on at least one study for this condition label.
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Typical Bipolar I Disorder enrolment sits around 195 participants.
Median target enrolment is 195 among the 27 trials that report a genuine target (sentinel values excluded). 10 of those (37%) plan for fewer than 100 participants.
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Bipolar I Disorder research is mostly interventional.
24 interventional and 3 observational studies make up this index (88.9% interventional). Study type is sponsor-reported on ClinicalTrials.gov.
Open and recent trials
27 total, page 1 of 1
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 |
|---|---|
| Phase 1 | 1 |
| Phase 2 | 4 |
| Phase 3 | 11 |
| Phase 4 | 4 |
Top Sponsors
Named interventions
Most-linked intervention names on Bipolar I Disorder records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.
US sites by state
Facility locations filed on Bipolar I Disorder trials. A trial with sites in several states counts in each.
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Related
What to do with this Bipolar I Disorder page
27 registered trials, 10 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.
- 10 Bipolar I Disorder trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
- AbbVie sponsors the most Bipolar I Disorder trials on record, review their full trial history before evaluating a specific study. See AbbVie's trials
- Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide
Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Bipolar I Disorder condition card totals 27 registered trials; most-linked intervention Placebo; top US site state California. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.