Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00035282
First received: May 2, 2002
Last updated: February 6, 2015
Last verified: February 2015

May 2, 2002
February 6, 2015
September 2001
December 2003   (final data collection date for primary outcome measure)
HAMD-17 total score at week 8. Tolerability. [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00035282 on ClinicalTrials.gov Archive Site
CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8 [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)
A Double-Blind, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder

A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

The duration of treatment is 8 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: aprepitant
    Other Name: MK0869
  • Drug: Comparator: placebo (unspecified)
Not Provided
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. Epub 2007 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
December 2003
December 2003   (final data collection date for primary outcome measure)

Patients with Major Depressive Disorder

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00035282
0869-060, Formally-103, 2006_401
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2015

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