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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00048607

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 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, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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)

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:

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_408, Formally-65MBS4W, MK0869-062
Study First Received:	November 4, 2002
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00048607
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 15, 2009