NCT00035048CompletedPhase 3
A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Geriatric Outpatients With Major Depressive Disorder
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 540
- Primary Endpoint
- HAMD-17 score </= 10 after 10 weeks; maintenance of antidepressant effect for 6-10 months; tolerability
Study Overview
Brief Summary
A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.
Detailed Description
The duration of treatment is 10 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
HAMD-17 score </= 10 after 10 weeks; maintenance of antidepressant effect for 6-10 months; tolerability
Time Frame: After 10 weeks & 6-10 months
Secondary Outcomes
- CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; MADRS total score change at Month 6, HAMA total score change at Month 6(6 Months)
Investigators
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