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NCT00107731 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 710
- Enrollment target
NCT00107731: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00107731 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 710 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00107731, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 710 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Interventions
- DRUG quetiapine fumarate
- DRUG lithium
- DRUG divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
What the finished NCT00107731 record still lists
NCT00107731 is an interventional study that assigns participants to a tested intervention. The registered 710 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which quetiapine fumarate is the first listed.
NCT00107731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00107731 about?
NCT00107731 is a clinical study titled "Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder". The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized tr...
What is the current status of trial NCT00107731?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 710 participants. The study started on 2004-04. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00107731?
The interventions under investigation include: quetiapine fumarate (DRUG), lithium (DRUG), divalproex (DRUG).
Who is sponsoring clinical trial NCT00107731?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00107731's enrollment target sits among peer trials
710 502nd of 2000 higher than 1,496 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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