Back to resultsTreatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
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
Long-term safety and tolerability.
Secondary Outcome Measures
Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034983
Brief Title
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)
Official Title
A Worldwide, Multicenter, Double-Blind, Parallel, Active-Controlled, Long-Term Safety Study of MK0869 in Outpatients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 29, 2001 (Actual)
Primary Completion Date
December 29, 2003 (Actual)
Study Completion Date
December 29, 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 1 year.
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
900 (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: paroxetine HCL
Primary Outcome Measure Information:
Title
Long-term safety and tolerability.
Time Frame
Duration of treatment
Secondary Outcome Measure Information:
Title
Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences
Time Frame
Duration of treatment
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
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
30373688
Citation
Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478.
Results Reference
derived
Learn more about this trial
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)
We'll reach out to this number within 24 hrs