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

Lilly

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: placebo

Drug: divalproex sodium

Drug: olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00094549

7029

F1D-MC-HGKQ

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.