Back to resultsTreatment of Patients With Major Depressive Disorder With MK0869 (0869-063)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0869, aprepitant
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Major depressive disorder
Sites / Locations
Outcomes
Primary Outcome Measures
HAMD-17 total score at week 8. Tolerability.
Secondary Outcome Measures
CGI-I Scale score at week 8 and at least a 50% reduction in the HAMD-17 total score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034944
Brief Title
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-063)
Official Title
A Double-Blind, Multicenter, Placebo Controlled, Acute and Extension Study of 2 Doses of MK0869 in the Treatment of Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 24, 2002 (Actual)
Primary Completion Date
December 17, 2003 (Actual)
Study Completion Date
December 17, 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 MK0869 in the treatment of depression.
Detailed Description
The duration of treatment is 8 weeks.
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
Masking
ParticipantInvestigator
Enrollment
495 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0869, aprepitant
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Primary Outcome Measure Information:
Title
HAMD-17 total score at week 8. Tolerability.
Secondary Outcome Measure Information:
Title
CGI-I Scale score at week 8 and at least a 50% reduction in the HAMD-17 total score.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major depressive disorder
12. IPD Sharing Statement
Citations:
PubMed Identifier
16248986
Citation
Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-063)
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