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

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