Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic)
* Drug: lithium (mood stabilizer)
* Drug: divalproex (mood stabilizer)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open-Label A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode. Able to understand and comply with the requirements of the study. Exclusion Criteria: Open-Label Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year. Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator. Previously randomized into this study or D1447C00126

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic)|nan|
|Drug: lithium (mood stabilizer)|nan|
|Drug: divalproex (mood stabilizer)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar I Disorder, Manic Depressive Disorder, Manic Depression, Mixed