NCT00035009

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
Completed

Started Sep 2001

Typical duration for phase_3 major-depressive-disorder

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2004

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

May 2, 2002

Last Update Submit

April 17, 2017

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

MK0869, aprepitantDRUG
Comparator: paroxetine HCLDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Major Depressive Disorder

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.

    PMID: 17825841BACKGROUND

  • 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 Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.

    PMID: 16248986RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

September 20, 2001

Primary Completion

December 22, 2003

Study Completion

March 24, 2004

Last Updated

April 18, 2017

Record last verified: 2017-04