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Treatment of Patients With Major Depressive Disorder With MK0869

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00048607
First received: November 4, 2002
Last updated: May 7, 2009
Last verified: May 2009
History of Changes
  Purpose

A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression


Condition Intervention Phase
Major Depressive Disorder
 Drug: aprepitant
Drug: Comparator: paroxetine HCL
Drug: Comparator: Placebo (Unspecified)
 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 Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • HAMD-17 total score at week 8. Tolerability. [ Time Frame: at week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-I Scale score at week 8 and Sheehan Disability Scale at week 8 [ Time Frame: at week 8 ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: January 2002
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aprepitant
    Other Name: MK0869
    Drug: Comparator: paroxetine HCL Drug: Comparator: Placebo (Unspecified)
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: NCT00048607

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00048607     History of Changes
Other Study ID Numbers: 2006_408, Formally-65MBS4W, MK0869-062
Study First Received: November 4, 2002
Last Updated: May 7, 2009
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 May 23, 2013