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

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

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

Drug Information available for: 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

No publications provided

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

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Antiemetics
Peripheral Nervous System Agents

Depressive Disorder, Major
Depressive Disorder
Antidepressive Agents
Aprepitant
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Disease
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Depressive Disorder, Major
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms

Pathologic Processes
Mental Disorders
Autonomic Agents
Therapeutic Uses
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Aprepitant

ClinicalTrials.gov processed this record on May 07, 2009