NCT00034801CompletedPhase 4
A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression
Eli Lilly and Company30 sites in 1 country378 target enrollmentStarted: September 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 378
- Locations
- 30
Study Overview
Brief Summary
This is a research study comparing the safety and efficacy of two active study medications
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Study Sites (30)
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