Treatment of Patients With Major Depressive Disorder With MK0869 (0869-068)(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 Geriatric Outpatients 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

Major Depressive Disorder

Intervention / Treatment

Detailed Description

The duration of treatment is 10 weeks.

Study Type

Interventional

Enrollment (Actual)

540

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

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
HAMD-17 score </= 10 after 10 weeks; maintenance of antidepressant effect for 6-10 months; tolerability Time Frame: After 10 weeks & 6-10 months	After 10 weeks & 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; MADRS total score change at Month 6, HAMA total score change at Month 6 Time Frame: 6 Months	6 Months

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)

November 21, 2001

Primary Completion (Actual)

December 29, 2003

Study Completion (Actual)

December 31, 2003

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria