Not Signed In -
Paroxetine |
Paxil; Paxil CR |
Clinical Trial: A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects with Major Depressive Disorder
This study has been completed.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: R228060 Drug: Placebo and Paroxetine | Phase II |
MedlinePlus related topics: Mental Health
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)
Expected Total Enrollment: 488
Study completion: May 2004
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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.
Location Information
New Jersey
JJ PRD Research Center, Titusville, New Jersey, 08560, United States
More Information
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 17, 2003
ClinicalTrials.gov Identifier: NCT00073203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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