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Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0869, aprepitant
Comparator: placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients with Major Depressive Disorder

Sites / Locations

    Outcomes

    Primary Outcome Measures

    HAMD-17 total score at week 8. Tolerability.

    Secondary Outcome Measures

    CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8

    Full Information

    First Posted
    May 2, 2002
    Last Updated
    April 17, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00035295
    Brief Title
    Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)
    Official Title
    A Double-Blind, Multicenter, Placebo-and Active-Controlled Acute and Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 8, 2001 (Actual)
    Primary Completion Date
    December 5, 2003 (Actual)
    Study Completion Date
    December 5, 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    A clinical study to determine the efficacy and safety of an Treatment of MK0869 in the treatment of depression.
    Detailed Description
    The duration of treatment is 8 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    584 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0869, aprepitant
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Primary Outcome Measure Information:
    Title
    HAMD-17 total score at week 8. Tolerability.
    Secondary Outcome Measure Information:
    Title
    CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patients with Major Depressive Disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16248986
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17825841
    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. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Snyopsis Links
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)

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