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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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 Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Aprepitant Paroxetine Mesylate

U.S. FDA Resources

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]

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 7, 2009
ClinicalTrials.gov Identifier:	NCT00048607 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents
Aprepitant

ClinicalTrials.gov processed this record on March 18, 2010