Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Haloperidol; Haloperidol decanoate; Olanzapine

Criteria

Inclusion Criteria:

• Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".

• Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.

Exclusion Criteria:

• Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.

• The duration of the current episode is more than 90 days at Visit 1.

• Have a history or a diagnosis of diabetes mellitus.

• Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).