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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035009
• Other study ID #: 0869-059
• Secondary ID: Formally-1A407MK
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2002
• Last updated: April 17, 2017
• Start date: September 20, 2001
• Est. completion date: March 24, 2004

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The duration of treatment is 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: March 24, 2004
• Est. primary completion date: December 22, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older
• Eligibility: Major Depressive Disorder

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• MK0869, aprepitant

• Comparator: paroxetine HCL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

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 (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychia — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated
Secondary	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