Trials / Completed
CompletedNCT00107731
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 710 (planned)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | quetiapine fumarate | |
| DRUG | lithium | |
| DRUG | divalproex |
Timeline
- Start date
- 2004-04-01
- Completion
- 2006-10-01
- First posted
- 2005-04-08
- Last updated
- 2009-03-25
Locations
166 sites across 18 countries: United States, Australia, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Norway, Poland, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00107731. Inclusion in this directory is not an endorsement.