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

Major Depressive Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073203
• Other study ID #: CR004339
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2003
• Last updated: August 27, 2009
• Est. completion date: May 2004

Study information

• Verified date: May 2004
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• R228060

• Placebo and Paroxetine

Locations

Country	Name	City	State
United States	JJ PRD Research Center	Titusville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

United States,