Quetiapine Fumarate Bipolar Maintenance Monotherapy
Phase 3
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00314184
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1255
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time from randomization to recurrence of a mood event
- Secondary Outcome Measures
Name Time Method Time from randomization to recurrence of a manic event Time from randomization to recurrence of a depressed event
Trial Locations
- Locations (1)
Research Site
🇺🇦Vinnitsa, Ukraine