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)
Data Collection
Bipolar and Related Disorders+1
+ Mental Disorders
+ Bipolar Disorder
Prevention Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.710 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 94 locations
Research Site
Scottsdale, United StatesResearch Site
Little Rock, United StatesResearch Site
Anaheim, United States