Quetiapine Fumarate Bipolar Maintenance Monotherapy

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate

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