Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goals of this study are:

A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.

B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.

C. To assess how olanzapine compares to divalproex.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Olanzapine; Valproic Acid

Criteria

Inclusion Criteria:

• You must be 18 to 65 years old.

• You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.

• You must be able to visit the doctor's office as scheduled for 15 weeks.

• All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.

Exclusion Criteria:

• You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.

• You are pregnant or breastfeeding

• You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.