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Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(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: NCT00048594
Recruitment Status : Completed
First Posted : November 5, 2002
Last Update Posted : May 5, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: aprepitant Drug: Comparator: placebo (unspecified) Phase 3

Detailed Description:
The duration of treatment is 20 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : January 3, 2002
Primary Completion Date : December 18, 2003
Study Completion Date : December 22, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: aprepitant
    Other Name: MK0869
    Drug: Comparator: placebo (unspecified)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Patients with Major Depressive Disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048594

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

Study Data/Documents: CSR Synopsis Link  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00048594     History of Changes
Other Study ID Numbers: 0869-065
First Posted: November 5, 2002    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action