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Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034983
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: aprepitant Drug: Comparator: paroxetine HCL Phase 3

Detailed Description:
The duration of treatment is 1 year.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Worldwide, Multicenter, Double-Blind, Parallel, Active-Controlled, Long-Term Safety Study of MK0869 in Outpatients With Major Depressive Disorder
Actual Study Start Date : October 29, 2001
Primary Completion Date : December 29, 2003
Study Completion Date : December 29, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: aprepitant
    Other Name: MK0869
    Drug: Comparator: paroxetine HCL

Primary Outcome Measures :
  1. Long-term safety and tolerability. [ Time Frame: Duration of treatment ]

Secondary Outcome Measures :
  1. Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences [ Time Frame: Duration of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Major Depressive Disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034983

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00034983     History of Changes
Other Study ID Numbers: 0869-066
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors