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| Sponsored by: |
AstraZeneca |
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00081380 |
Purpose
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.
| Condition | Intervention | Phase |
|
Bipolar Disorder |
Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic) Drug: lithium (mood stabilizer) Drug: divalproex (mood stabilizer) |
Phase III |
| MedlinePlus related topics: | Bipolar Disorder |
| Drug Information available for: | Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated) |
| Estimated Enrollment: | 710 |
| Study Start Date: | March 2004 |
| Study Completion Date: | September 2006 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Open-Label
Exclusion Criteria:
Open-Label
Contacts and Locations![]() |
Show 94 Study Locations |
| AstraZeneca |
| Study Director: | AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca |
More Information
| Study ID Numbers: | D1447C00127 |
| First Received: | April 9, 2004 |
| Last Updated: | December 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00081380 |
| Health Authority: | United States: Food and Drug Administration |
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