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NCT00080314 · ClinicalTrials.gov registry record · Phase 3
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT00080314: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00080314 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
NCT00080314, 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 study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
Interventions
- DRUG Placebo
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
What the finished NCT00080314 record still lists
NCT00080314 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 2 interventions - of which Placebo is the first listed.
NCT00080314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00080314 about?
NCT00080314 is a clinical study titled "Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode". The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
What is the current status of trial NCT00080314?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2004-01. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00080314?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00080314?
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 NCT00080314'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
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