Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00094432 · ClinicalTrials.gov registry record · Phase 3
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
A Phase 3 study of Bipolar I Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 650
- Enrollment target
- 20
- Study locations
NCT00094432: Completed Phase 3 study of Bipolar I Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00094432 is a Phase 3 study of Bipolar I Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 650 participants, above the 305-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (113% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094432, a Phase 3 study of Bipolar I Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 650 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aripiprazole
Study Locations (20)
California
- Local Institution - La Mesa
- Local Institution - La Palma
- Local Institution - Long Beach
- Local Institution - Redlands
- Local Institution - San Diego
- Local Institution - Sherman Oaks
Florida
- Local Institution - Coral Springs
- Local Institution - Jacksonville
- Local Institution - St. Petersburg
Illinois
- Local Institution - Edwardsville
- Local Institution - Oak Brook
- Local Institution - Springfield
Louisiana
- Local Institution - New Orleans
- Local Institution - Shreveport
Arizona
- Local Institution - Mesa
District of Columbia
- Local Institution - Washington D.C.
Georgia
- Local Institution - Marietta
Indiana
- Local Institution - Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
What the finished NCT00094432 record still lists
NCT00094432 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, above the 305-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (113% higher).
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00094432 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00094432 about?
NCT00094432 is a clinical study titled "A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode". The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
What is the current status of trial NCT00094432?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 650 participants. The study started on 2004-06. Estimated completion is 2006-11.
What conditions does trial NCT00094432 study?
This clinical trial studies the following conditions: Bipolar I Disorder.
What interventions are being tested in trial NCT00094432?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00094432?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00094432 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00094432's enrollment target sits among peer trials
650 3rd of 26 higher than 24 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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.
RECRUITING · Phase 3
-
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
RECRUITING · Phase 3
-
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
RECRUITING · Phase 3
-
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
COMPLETED · Phase 3
-
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
COMPLETED · Phase 3
-
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
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02934477 · 650 participants
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis
- NCT04579120 · 650 participants
Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
- NCT04875702 · 650 participants · Phase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
- NCT05046600 · 650 participants
Registry of Arthrex Hand and Wrist Products
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia