Clinical Trial: A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects with Major Depressive Disorder


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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 and Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

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

MedlinePlus related topics: Mental Health

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:

Expected Total Enrollment: 488

Study completion: May 2004

Eligibility

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both

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.

Location Information

New Jersey
JJ PRD Research Center, Titusville, New Jersey, 08560, United States

More Information

Study ID Numbers: R228060-MDD-201
Record last reviewed: May 2004
Record first received: November 17, 2003
ClinicalTrials.gov Identifier: NCT00073203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20

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