Treatment of Patients With Major Depressive Disorder With MK0869 - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00035009

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 III

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study
Official Title:	A Double-Blind, Multicenter, Placebo- and Active-Controlled Acute and Extension Study of MK-0869 in the Treatment of Patients With Major Depressive Disorder With Melancholic Features

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

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

Show 25 Study Locations

Sponsors and Collaborators

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]

Publications indexed to this study:

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.

Study ID Numbers:	2006_402, Formally-1A407
Study First Received:	May 2, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00035009
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder

Paroxetine
Serotonin
Aprepitant
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009