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Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(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: NCT00035282
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : February 9, 2015
Sponsor:
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 8 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder
Study Start Date : September 2001
Primary Completion Date : December 2003
Study Completion Date : December 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. HAMD-17 total score at week 8. Tolerability. [ Time Frame: at week 8 ]

Secondary Outcome Measures :
  1. 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 ]


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
Criteria
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): NCT00035282


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00035282     History of Changes
Other Study ID Numbers: 0869-060
Formally-103
2006_401
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015

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