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Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048607
Recruitment Status : Completed
First Posted : November 5, 2002
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 4, 2002
First Posted Date  ICMJE November 5, 2002
Last Update Posted Date May 5, 2017
Actual Study Start Date  ICMJE July 30, 2002
Actual Primary Completion Date December 31, 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
HAMD-17 total score at week 8. Tolerability. [ Time Frame: at week 8 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
CGI-I Scale score at week 8 and Sheehan Disability Scale at week 8 [ Time Frame: at week 8 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)
Official Title  ICMJE A Double-Blind, Multicenter, Placebo and Active-Controlled, Acute Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: aprepitant
    Other Name: MK0869
  • Drug: Comparator: paroxetine HCL
  • Drug: Comparator: Placebo (Unspecified)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2006)
600
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 31, 2003
Actual Primary Completion Date December 31, 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Patients with Major Depressive Disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00048607
Other Study ID Numbers  ICMJE 0869-062
Formally-65MBS4W
MK0869-062
2006_408
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP