Status:
COMPLETED
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of ...
Eligibility Criteria
Inclusion
- Diagnosed with a mixed episode of bipolar I disorder.
- Have had at least one previous manic or mixed episode associated with bipolar disorder
- You must be between 18 and 60 years old.
- You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.
- If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.
Exclusion
- You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.
- You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.
- Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).
- You are allergic to any of the medications involved in this study.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00402324
Start Date
December 1 2006
End Date
February 1 2008
Last Update
June 3 2009
Active Locations (1)
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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.
Hialeah, Florida, United States, 33016