Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will assess any efficacious benefit and any safety issues associated with the concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I disorder, manic or mixed episodes

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Carbamazepine; Olanzapine

Criteria

Inclusion Criteria:

1. Have a diagnosis of bipolar disorder and currently meet DSM-IV-TR criteria for a manic or mixed episode

2. Female patients must test negative on a serum pregnancy test at the time of enrollment and agree to use medically accepted contraception throughout the study.

3. Have YMRS score > or = 20 at both the screening (Visit 1) and randomization (Visit 2) visits.

Exclusion Criteria:

1. Have participated (been randomized) in a clinical trial of another investigational drug (including olanzapine or carbamazepine) within 30 days prior to Visit 1

2. Have a history of agranulocytosis (absolute neutrophil count< 500/uL) during the patient's lifetime

3. Have acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (HgbA1c>8%); severe hypertriglyceridemia (fasting triglycerides > or = 500 mg/dl;hepatic insufficiency (specifically any degree of jaundice); recent cerebrovascular accidents; uncontrolled seizure disorders; serious acute systemic infection or immunologic disease: unstable cardiovascular disorders (including ischemic heart disease); or renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases (specifically current absolute neutrophil count , <1500/uL)

4. Have a substance dependence (except nicotine or caffeine), based on DSM-IV-TR criteria, within the 30 days prior to study entry.

5. Require concomitant treatment with any other medication with primarily central nervous system (CNS) activity, other than those allowed in the protocol.