Back to resultsEfficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seroquel®, quetiapine fumarate (atypical antipsychotic)
lithium (mood stabilizer)
divalproex (mood stabilizer)
Sponsored by
About this trial
This is an interventional prevention trial for Bipolar Disorder focused on measuring Bipolar I Disorder, Manic Depressive Disorder, Manic Depression, Mixed
Eligibility Criteria
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
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Outcomes
Primary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00081380
Brief Title
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I Disorder, Manic Depressive Disorder, Manic Depression, Mixed
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
710 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Seroquel®, quetiapine fumarate (atypical antipsychotic)
Intervention Type
Drug
Intervention Name(s)
lithium (mood stabilizer)
Intervention Type
Drug
Intervention Name(s)
divalproex (mood stabilizer)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Birmingham
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United States
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Scottsdale
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Little Rock
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Cerritos
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Orange
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Pico Rivera
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Riverside
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Farmington
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New Britain
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Jacksonville
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Orlando
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Smyrna
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Hoffman Estates
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Joliet
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Vancouver
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Victoria
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Winnipeg
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Halifax
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Hamilton
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Kingston
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Markham
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Montreal
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Quebec
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12. IPD Sharing Statement
Citations:
PubMed Identifier
23761037
Citation
Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
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