Back to resultsLong Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
aprepitant
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Patients with Major Depressive Disorder
Sites / Locations
Outcomes
Primary Outcome Measures
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048594
Brief Title
Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2002 (Actual)
Primary Completion Date
December 18, 2003 (Actual)
Study Completion Date
December 22, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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 20 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aprepitant
Other Intervention Name(s)
MK0869
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Primary Outcome Measure Information:
Title
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months
Time Frame
after 10 weeks of treatment and over 6-10 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
Week 10 at Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with Major Depressive Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
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