Status:
COMPLETED
Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00190892
Start Date
September 1 2004
End Date
June 1 2006
Last Update
January 26 2007
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Everton Park, Queensland, Australia
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Epping, Victoria, Australia
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Frankston, Victoria, Australia
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Malvern, Victoria, Australia