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

Lilly

Status and phase

Completed

Phase 4

Conditions

Bipolar I Disorder

Treatments

Drug: olanzapine

Drug: divalproex

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00402324

F1D-US-HGMO

10825

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.