Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)

May 2, 2017 updated by: Merck Sharp & Dohme LLC

A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of treatment is 20 months.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients with Major Depressive Disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months
Time Frame: after 10 weeks of treatment and over 6-10 months
after 10 weeks of treatment and over 6-10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6.
Time Frame: Week 10 at Month 6
Week 10 at Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2002

Primary Completion (Actual)

December 18, 2003

Study Completion (Actual)

December 22, 2003

Study Registration Dates

First Submitted

November 4, 2002

First Submitted That Met QC Criteria

November 4, 2002

First Posted (Estimate)

November 5, 2002

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0869-065
  • Formally-35MRB2
  • MK0869-065
  • 2006_405

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis Link

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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