Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00035009
• Collaborator: (none)
• Enrollment: 468
• Actual Duration (Months): 30.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: MK0869, aprepitant; Drug: Comparator: paroxetine HCL	Phase 3

Detailed Description

The duration of treatment is 8 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 468 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Multicenter, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder With Melancholic Features
• Actual Study Start Date: Sep 20, 2001
• Actual Primary Completion Date: Dec 22, 2003
• Actual Study Completion Date: Mar 24, 2004

Outcome Measures

Primary Outcome Measures

1. Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated []

Secondary Outcome Measures

1. Actual CGI-I score at week 8, improving social disability by change from baseline in Sheehan Disability Score at Week 8, change from baseline in the HAMA score at week 8, change from baseline in depressed mood of the HAMD-17 at week 8 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Major Depressive Disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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 Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00035009
• Other Study ID Numbers: 0869-059; Formally-1A407; MK0869-059; 2006_402
• First Posted: May 3, 2002
• Last Update Posted: Apr 18, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Aprepitant; Paroxetine

Study Results

No Results Posted as of Apr 18, 2017