Back to resultsA 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R228060
Placebo and Paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility 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.
Sites / Locations
- JJ PRD Research Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00073203
First Posted
November 17, 2003
Last Updated
August 27, 2009
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00073203
Brief Title
A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
488 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
R228060
Intervention Type
Drug
Intervention Name(s)
Placebo and Paroxetine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
JJ PRD Research Center
City
Titusville
State/Province
New Jersey
ZIP/Postal Code
08560
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder
We'll reach out to this number within 24 hrs