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

Condition(s) targeted: Bipolar I Disorder

Intervention: quetiapine fumarate (Drug); lithium (Drug); divalproex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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)

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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:

- 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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Starting date: April 2004
Last updated: October 3, 2007