Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression | NCT00060489 | Trialant
CompletedInterventionalPhase 3Updated Jan 26, 2011
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
ClinicalTrials.gov ID
NCT00060489
Lead Sponsor
AstraZenecaINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Last Update Posted
Jan 26, 2011Estimated
Start Date
Sep 2002
Primary Completion Date
Sep 2003Actual
Completion Date
Sep 2003Actual
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.
Bipolar Disorder
Depression, Bipolar
SEROQUEL (quetiapine fumarate) Tablets
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written Informed Consent;
Bipolar disorder with most recent episode depressed;
Outpatient status
Exclusion Criteria:
Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks