Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Lithium Carbonate; Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed

• The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20

• The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12

Exclusion Criteria:

• Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk

• Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation

• Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug