Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown efficacy in bipolar depressive episodes in retrospective studies. However, there has been no prospective study about the monotherapy of olanzapine. The investigators conducted a randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for treatment of the depressed phase of bipolar disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University, China
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• Outpatients with clinical diagnosis of bipolarⅠdisorder

• MADRS total score ≥ 20

• CGI-S rating ≥ 4

• Normal results of physical examinations, laboratory and electrocardiogram tests

• Being taken care of by a guardians during the trial

Exclusion Criteria:

• Pregnant or lactating women

• YMRS total score ≥ 15

• Treatment with olanzapine within 3 months prior to study entry

• Retrospective history of poor antidepressive response to or intolerance of olanzapine

• Mental retardation

• Addictive disorder

• Diabetes mellitus

• Dyslipidaemia

• Cardiovascular diseases

• Hypertension