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

A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression

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.

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