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

This study has been completed.

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00073203
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: R228060
Drug: Placebo and Paroxetine
Phase II

MedlinePlus related topics:   Depression   

Drug Information available for:   Paroxetine    Paroxetine hydrochloride    Paroxetine Mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Estimated Enrollment:   488
Estimated Study Completion Date:   May 2004

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073203

Locations
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.
  More Information


Study ID Numbers:   R228060-MDD-201
First Received:   November 17, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00073203
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008




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