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| Sponsor: | 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.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic) Drug: lithium (mood stabilizer) Drug: divalproex (mood stabilizer) |
Phase III |
| 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| Study Director: | AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca |
More Information
| Study ID Numbers: | D1447C00127 |
| Study First Received: | April 9, 2004 |
| Last Updated: | December 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00081380 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bipolar I Disorder Manic Depressive Disorder Manic Depression, Mixed |
|
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Antipsychotic Agents Pharmacologic Actions |
Affective Disorders, Psychotic Quetiapine Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents Lithium |