Status:
COMPLETED
Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00094549
Start Date
October 1 2004
End Date
December 1 2006
Last Update
January 26 2007
Active Locations (42)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Scottsdale, Arizona, United States, 85251
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Beverly Hills, California, United States, 90211
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Costa Mesa, California, United States, 92626
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
Escondido, California, United States, 92025