Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00257972 · ClinicalTrials.gov registry record · Phase 3
Study of Aripiprazole in Patients With Bipolar I Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT00257972: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00257972 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00257972, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
Interventions
- DRUG aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00257972 record still lists
NCT00257972 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which aripiprazole is the first listed.
NCT00257972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00257972 about?
NCT00257972 is a clinical study titled "Study of Aripiprazole in Patients With Bipolar I Disorder". The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
What is the current status of trial NCT00257972?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2004-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00257972?
The interventions under investigation include: aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00257972?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00257972's enrollment target sits among peer trials
400 922nd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
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