Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder
4 other identifiers
interventional
800
0 countries
N/A
Brief Summary
A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Jan 2002
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
January 3, 2002
CompletedFirst Submitted
Initial submission to the registry
November 4, 2002
CompletedFirst Posted
Study publicly available on registry
November 5, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2003
CompletedMay 5, 2017
May 1, 2017
2 years
November 4, 2002
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months
after 10 weeks of treatment and over 6-10 months
Secondary Outcomes (1)
CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6.
Week 10 at Month 6
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2002
First Posted
November 5, 2002
Study Start
January 3, 2002
Primary Completion
December 18, 2003
Study Completion
December 22, 2003
Last Updated
May 5, 2017
Record last verified: 2017-05