Quetiapine Fumarate Bipolar Maintenance Monotherapy

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00314184

Run by

AstraZeneca

People needed

1255

Starts

2005-03-01

Expected to finish

2007-07-01

Last updated by the study team

2008-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — San Diego, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — North Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Eagle, Idaho, United States
• Research Site — Hoffman Estates, Illinois, United States
• Research Site — Terre Haute, Indiana, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Flowood, Mississippi, United States
• Research Site — Saint Charles, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Clementon, New Jersey, United States
• Research Site — Rochester, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Portland, Oregon, United States
• Research Site — Salem, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — Cerritos, California, United States

Full record on ClinicalTrials.gov

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