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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00035295
First received: May 2, 2002
Last updated: March 15, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Estimated Enrollment: 572
Study Start Date: November 2001
Study Completion Date: December 2003
Detailed Description:

The duration of treatment is 8 weeks.

  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: NCT00035295

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

Publications:
Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00035295     History of Changes
Other Study ID Numbers: 2006_404, Formally-30915, MK0869-061
Study First Received: May 2, 2002
Last Updated: March 15, 2011
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 16, 2014