Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00035009
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 MK0869 in the treatment of depression


Condition Intervention Phase
Major Depressive Disorder
Drug: MK0869, aprepitant
Drug: Comparator: paroxetine HCL
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 MK0869 in the Treatment of Patients With Major Depressive Disorder With Melancholic Features

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated

Secondary Outcome Measures:
  • Actual CGI-I score at week 8, improving social disability by change from baseline in Sheehan Disability Score at Week 8, change from baseline in the HAMA score at week 8, change from baseline in depressed mood of the HAMD-17 at week 8

Estimated Enrollment: 450
Study Start Date: September 2001
Study Completion Date: March 2004
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

Major Depressive Disorder

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035009

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: NCT00035009     History of Changes
Other Study ID Numbers: 2006_402, Formally-1A407, MK0869-059
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
Paroxetine
Aprepitant
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 28, 2014