Long Term Treatment of Patients With Major Depressive Disorder With MK0869

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00048594
First received: November 4, 2002
Last updated: July 30, 2008
Last verified: July 2008
  Purpose

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: May 2002
Study Completion Date: March 2004
Intervention Details:
    Drug: aprepitant
    Other Name: MK0869
    Drug: Comparator: placebo (unspecified)
Detailed Description:

The duration of treatment is 20 months.

  Eligibility

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

Patients with Major Depressive Disorder

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

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00048594     History of Changes
Other Study ID Numbers: 2006_405, Formally-35MRB2, MK0869-065
Study First Received: November 4, 2002
Last Updated: July 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 15, 2014