Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression
2 other identifiers
interventional
378
1 country
30
Brief Summary
This is a research study comparing the safety and efficacy of two active study medications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 depression
Started Sep 2001
Shorter than P25 for phase_4 depression
30 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
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 2, 2002
CompletedFirst Posted
Study publicly available on registry
May 3, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedJuly 19, 2006
July 1, 2006
May 2, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects 18-60 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:
- Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
- Female subjects who are either pregnant or nursing
- Uncorrected hypothyroidism or hyperthyroidism
- Narrow-angle glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Tuscaloosa, Alabama, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Chula Vista, California, United States
Unknown Facility
Lafayette, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Poway, California, United States
Unknown Facility
Rosemeade, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
New Britain, Connecticut, United States
Unknown Facility
Winter Park, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Gaithersburg, Maryland, United States
Unknown Facility
Mount Pleasant, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Lincoln, Nebraska, United States
Unknown Facility
Clementon, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, 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
May 2, 2002
First Posted
May 3, 2002
Study Start
September 1, 2001
Study Completion
March 1, 2003
Last Updated
July 19, 2006
Record last verified: 2006-07