Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
2 other identifiers
interventional
326
1 country
21
Brief Summary
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2001
Shorter than P25 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 30, 2002
CompletedFirst Posted
Study publicly available on registry
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedJuly 19, 2006
July 1, 2006
April 30, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Berkley, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
San Marcos, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Middleton, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Winter Park, Florida, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Hoffman Estates, Illinois, United States
Unknown Facility
Natick, Massachusetts, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Clementon, New Jersey, United States
Unknown Facility
Olean, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Madison, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Roanoke, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 30, 2002
First Posted
May 1, 2002
Study Start
August 1, 2001
Study Completion
August 1, 2002
Last Updated
July 19, 2006
Record last verified: 2006-07