Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: November 4, 2002
Last updated: March 10, 2015
Last verified: March 2015

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

Condition Intervention Phase
Major Depressive Disorder
Drug: aprepitant
Drug: Comparator: placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months [ Time Frame: after 10 weeks of treatment and over 6-10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6. [ Time Frame: Week 10 at Month 6 ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: January 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aprepitant
    Other Name: MK0869
    Drug: Comparator: placebo (unspecified)
Detailed Description:

The duration of treatment is 20 months.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Patients with Major Depressive Disorder

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048594

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00048594     History of Changes
Other Study ID Numbers: 0869-065, Formally-35MRB2, MK0869-065, 2006_405
Study First Received: November 4, 2002
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 02, 2015