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Clinical Trials/NCT00035048
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

Merck Sharp & Dohme LLC0 sites540 target enrollmentStarted: November 21, 2001Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

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