- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034983
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)
April 24, 2017 updated by: Merck Sharp & Dohme LLC
A Worldwide, Multicenter, Double-Blind, Parallel, Active-Controlled, Long-Term Safety Study of MK0869 in 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
Intervention / Treatment
Detailed Description
The duration of treatment is 1 year.
Study Type
Interventional
Enrollment (Actual)
900
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
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 |
---|---|
Long-term safety and tolerability.
Time Frame: Duration of treatment
|
Duration of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences
Time Frame: Duration of treatment
|
Duration of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 29, 2001
Primary Completion (Actual)
December 29, 2003
Study Completion (Actual)
December 29, 2003
Study Registration Dates
First Submitted
May 2, 2002
First Submitted That Met QC Criteria
May 2, 2002
First Posted (Estimate)
May 3, 2002
Study Record Updates
Last Update Posted (Actual)
April 26, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Antiemetics
- Gastrointestinal Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Neurokinin-1 Receptor Antagonists
- Paroxetine
- Aprepitant
Other Study ID Numbers
- 0869-066
- Formally-497B
- MK0869-066
- 2006_407
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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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