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