Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients

AstraZeneca1 site in 1 country1,255 target enrollmentMarch 2005

ConditionsBipolar Disorder

Drugsquetiapine fumarate

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bipolar Disorder
Sponsor: AstraZeneca
Enrollment: 1255
Locations: 1
Primary Endpoint: Time from randomization to recurrence of a mood event
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

July 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•18 years or older
•A diagnosis of Bipolar I Disorder
•Have a current manic, depressed or mixed episode
•Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
•Female patients of childbearing potential must be using a reliable method of contraception

Exclusion Criteria

•Pregnancy
•Substance or alcohol dependence at enrollment
•Unstable thyroid function
•Unstable Diabetes
•Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
•Use of an experimental drug within 30 days of enrollment