Back to resultsTreatment of Patients With Major Depressive Disorder With MK0869 (0869-059)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0869, aprepitant
Comparator: paroxetine HCL
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
Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated
Secondary Outcome Measures
Actual CGI-I score at week 8, improving social disability by change from baseline in Sheehan Disability Score at Week 8, change from baseline in the HAMA score at week 8, change from baseline in depressed mood of the HAMD-17 at week 8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035009
Brief Title
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)
Official Title
A Double-Blind, Multicenter, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder With Melancholic Features
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 20, 2001 (Actual)
Primary Completion Date
December 22, 2003 (Actual)
Study Completion Date
March 24, 2004 (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
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0869, aprepitant
Intervention Type
Drug
Intervention Name(s)
Comparator: paroxetine HCL
Primary Outcome Measure Information:
Title
Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated
Secondary Outcome Measure Information:
Title
Actual CGI-I score at week 8, improving social disability by change from baseline in Sheehan Disability Score at Week 8, change from baseline in the HAMA score at week 8, change from baseline in depressed mood of the HAMD-17 at week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Citations:
PubMed Identifier
17825841
Citation
Liu KS, Snavely DB, Ball WA, Lines CR, Reines SA, Potter WZ. Is bigger better for depression trials? J Psychiatr Res. 2008 Jul;42(8):622-30. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.
Results Reference
background
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 Links
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 (0869-059)
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