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A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00073203
Recruitment Status : Completed
First Posted : November 19, 2003
Last Update Posted : August 28, 2009
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:

The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder.

Approximately 488 subjects will be involved in the study.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: R228060 Drug: Placebo and Paroxetine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 6- Week, Randomized, Double-Blind, Parallel-Group, Active-and Placebo-Controlled Trial to Assess the Efficacy of R228060 in Adult Subjects With Major Depressive Disorder (MDD)
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Paroxetine





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up.
  • Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol.
  • The subject also needs to be an outpatient to participate in this study.

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 ClinicalTrials.gov identifier (NCT number): NCT00073203


Locations
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United States, New Jersey
JJ PRD Research Center
Titusville, New Jersey, United States, 08560
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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ClinicalTrials.gov Identifier: NCT00073203     History of Changes
Other Study ID Numbers: CR004339
First Posted: November 19, 2003    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: May 2004

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors