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

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.
ClinicalTrials.gov Identifier: NCT00035009
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: MK0869, aprepitant Drug: Comparator: paroxetine HCL Phase 3

Detailed Description:
The duration of treatment is 8 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
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
Actual Study Start Date : September 20, 2001
Primary Completion Date : December 22, 2003
Study Completion Date : March 24, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 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


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

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.

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 Posted: May 3, 2002    Key Record Dates
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
Paroxetine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors