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

Purpose

A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: aprepitant Drug: Comparator: placebo (unspecified)	Phase III

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder

Further study details as provided by Merck:

Primary Outcome Measures:

Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months [ Time Frame: after 10 weeks of treatment and over 6-10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6. [ Time Frame: Week 10 at Month 6 ] [ Designated as safety issue: No ]

Enrollment:	800
Study Start Date:	May 2002
Study Completion Date:	March 2004

Detailed Description:

The duration of treatment is 20 months.

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: NCT00048594

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_405, Formally-35MRB2, MK0869-065
First Received:	November 4, 2002
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00048594
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

Aprepitant

Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes

Disease

Autonomic Agents

Therapeutic Uses

Physiological Effects of Drugs

Gastrointestinal Agents

Antiemetics

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00048594