Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)

Major Depressive Disorder Clinical Trial

Official title:

A Double-Blind, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035282
• Other study ID #: 0869-060
• Secondary ID: Formally-1032006
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2002
• Last updated: February 6, 2015
• Start date: September 2001
• Est. completion date: December 2003

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

The duration of treatment is 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Patients with Major Depressive Disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• aprepitant

• Comparator: placebo (unspecified)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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	HAMD-17 total score at week 8. Tolerability.		at week 8	No
Secondary	CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8		at week 8	No