Treatment of Patients With Major Depressive Disorder With MK0869 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 4, 2002

Last Updated Date

May 7, 2009

Start Date ^ICMJE

January 2002

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HAMD-17 total score at week 8. Tolerability. [ Time Frame: at week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

HAMD-17 total score at week 8. Tolerability.

Change History

Complete list of historical versions of study NCT00048607 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CGI-I Scale score at week 8 and Sheehan Disability Scale at week 8 [ Time Frame: at week 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

CGI-I Scale score at week 8 and Sheehan Disability Scale at week 8

Descriptive Information

Brief Title ^ICMJE

Treatment of Patients With Major Depressive Disorder With MK0869

Official Title ^ICMJE

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

Brief Summary

A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

Detailed Description

The duration of treatment is 8 weeks.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: aprepitant
Drug: Comparator: paroxetine HCL
Drug: Comparator: Placebo (Unspecified)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Patients with Major Depressive Disorder

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00048607

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2006_408, Formally-65MBS4W, MK0869-062

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP