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NCT00081380 · ClinicalTrials.gov registry record · Phase 3
Efficacy and 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
NCT00081380 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 710 participants.
The verdict
NCT00081380, 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 Seroquel®, quetiapine fumarate (atypical antipsychotic)
- DRUG lithium (mood stabilizer)
- DRUG divalproex (mood stabilizer)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2004-03 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081380
The ClinicalTrials.gov registry entry for NCT00081380 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 710 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Seroquel®, quetiapine fumarate (atypical antipsychotic) is the first listed.
NCT00081380 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00081380 about?
NCT00081380 is a clinical study titled "Efficacy and 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 NCT00081380?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 710 participants. The study started on 2004-03. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00081380?
The interventions under investigation include: Seroquel®, quetiapine fumarate (atypical antipsychotic) (DRUG), lithium (mood stabilizer) (DRUG), divalproex (mood stabilizer) (DRUG).
Who is sponsoring clinical trial NCT00081380?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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