Not Signed In -
Olanzapine Disintegrating Tablets |
Zyprexa Zydis Injection |
Clinical Trial: Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
This study has been completed.
|
Purpose
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Olanzapine and investigational agent | Phase IV |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
Further Study Details:
Expected Total Enrollment: 326
Study start: August 2001; Study completion: August 2002
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Male or female subject, 18-70 years of age
- Female subjects of childbearing potential must be using a medically accepted means of contraception
- Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
- Subjects must be considered reliable
Exclusion:
- Female subjects who are either pregnant or nursing
- Uncorrected hypothyroidism or hyperthyroidism
- Narrow-angle glaucoma
- Subjects who present a serious and immediate risk of endangering him or herself
Location Information
California
Torrance, California, United States
San Marcos, California, United States
Los Angeles, California, United States
Orange, California, United States
Berkley, California, United States
Colorado
Denver, Colorado, United States
Connecticut
Middleton, Connecticut, United States
District of Columbia
Washington, District of Columbia, United States
Florida
Winter Park, Florida, United States
Idaho
Boise, Idaho, United States
Illinois
Hoffman Estates, Illinois, United States
Massachusetts
Natick, Massachusetts, United States
Missouri
St. Louis, Missouri, United States
Nevada
Las Vegas, Nevada, United States
New Jersey
Clementon, New Jersey, United States
New York
Olean, New York, United States
Pennsylvania
Philadelphia, Pennsylvania, United States
Tennessee
Madison, Tennessee, United States
Texas
Houston, Texas, United States
Virginia
Roanoke, Virginia, United States
Richmond, Virginia, United States
More Information
Study ID Numbers: 5528
Record last reviewed: September 2002
Last Updated: October 13, 2004
Record first received: April 30, 2002
ClinicalTrials.gov Identifier: NCT00034580
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: September 2002
Last Updated: October 13, 2004
Record first received: April 30, 2002
ClinicalTrials.gov Identifier: NCT00034580
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
email this page
print this page
bookmark this page
feedback on this page
