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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00035009

First received: May 2, 2002

Last updated: March 15, 2011

Last verified: March 2011

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: 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:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Aprepitant Fosaprepitant Paroxetine Mesylate Fosaprepitant dimeglumine

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of Efficacy of the Substance P (Neurokinin(1) Receptor) Antagonist Aprepitant in the Treatment of Major Depressive Disorder. Biol Psychiatry. 2005 Oct 21; [Epub ahead of print]

Liu KS, Snavely DB, Ball WA, Lines CR, Reines SA, Potter WZ. Is bigger better for depression trials? J Psychiatr Res. 2008 Jul;42(8):622-30. Epub 2007 Sep 7.

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 June 17, 2013

To Top