Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Key facts

Study ID

NCT00083954

Run by

AstraZeneca

People needed

530

Starts

2004-06-01

Expected to finish

2005-08-01

Last updated by the study team

2013-01-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

You may not qualify if…

• More than 8 mood episodes in the past year from screen (visit 1);
• A current Axis I disorder other than bipolar disorder within 6 months of screening;
• patients with clinically significant abnormal laboratory findings in the investigator's judgment

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Cerritos, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrance, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Maitland, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Boise, Idaho, United States
• Research Site — Oak Brook, Illinois, United States
• Research Site — Overbrook Terrace, Illinois, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Clementon, New Jersey, United States
• Research Site — Moorestown, New Jersey, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Brooklyn, New York, United States
• Research Site — New York, New York, United States
• Research Site — Staten Island, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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