A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosed with a mixed episode of bipolar I disorder.

• Have had at least one previous manic or mixed episode associated with bipolar disorder

• You must be between 18 and 60 years old.

• You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.

• If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.

Exclusion Criteria:

• You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.

• You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.

• Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).

• You are allergic to any of the medications involved in this study.