Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

Lilly

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: carbamazepine

Drug: olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00190892

F1D-MC-HGKR

7031

Details and patient eligibility

About

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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a diagnosis of bipolar disorder and currently meet DSM-IV-TR criteria for a manic or mixed episode
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.
Have YMRS score > or = 20 at both the screening (Visit 1) and randomization (Visit 2) visits.

Exclusion criteria

Have participated (been randomized) in a clinical trial of another investigational drug (including olanzapine or carbamazepine) within 30 days prior to Visit 1
Have a history of agranulocytosis (absolute neutrophil count< 500/uL) during the patient's lifetime
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)
Have a substance dependence (except nicotine or caffeine), based on DSM-IV-TR criteria, within the 30 days prior to study entry.
Require concomitant treatment with any other medication with primarily central nervous system (CNS) activity, other than those allowed in the protocol.