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Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035295
First Posted: May 3, 2002
Last Update Posted: April 18, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

A clinical study to determine the efficacy and safety of an Treatment of MK0869

in the treatment of depression.


Condition Intervention Phase
Major Depressive Disorder Drug: MK0869, aprepitant Drug: Comparator: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter, Placebo-and Active-Controlled Acute and Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HAMD-17 total score at week 8. Tolerability.

Secondary Outcome Measures:
  • CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8

Enrollment: 584
Actual Study Start Date: November 8, 2001
Study Completion Date: December 5, 2003
Primary Completion Date: December 5, 2003 (Final data collection date for primary outcome measure)
Detailed Description:
The duration of treatment is 8 weeks.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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): NCT00035295


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

Publications:
Study Data/Documents: CSR Snyopsis Links  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00035295     History of Changes
Other Study ID Numbers: 0869-061
2006_404
First Submitted: May 2, 2002
First Posted: May 3, 2002
Last Update Posted: April 18, 2017
Last Verified: April 2017

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