A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Completed · Phase 4 · Has a placebo group
Conditions studied: Bipolar I Disorder
In brief
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 bipolar I disorder.
Key facts
- Study ID
- NCT00402324
- Run by
- Eli Lilly and Company
- People needed
- 202
- Starts
- 2006-12-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2009-06-03
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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