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

This study has been completed.

First Received on November 17, 2003. Last Updated on August 27, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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)

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00073203 History of Changes
Other Study ID Numbers:	CR004339
Study First Received:	November 17, 2003
Last Updated:	August 27, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012