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

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.

Completed

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

JJ PRD Research Center

Titusville, New Jersey, 08560, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

R228060

Drug

Placebo and Paroxetine

Drug

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Registry information

Official study 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)

Important dates

Study completion: 2004
First posted: Nov 19, 2003
Registry last updated: Aug 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed