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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035009
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 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
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 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

Enrollment: 468
Actual Study Start Date: September 20, 2001
Study Completion Date: March 24, 2004
Primary Completion Date: December 22, 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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): NCT00035009


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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00035009     History of Changes
Other Study ID Numbers: 0869-059
Formally-1A407
MK0869-059
2006_402
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
Paroxetine
Aprepitant
Fosaprepitant
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists