NCT00073203

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

August 28, 2009

Status Verified

May 1, 2004

First QC Date

November 17, 2003

Last Update Submit

August 27, 2009

Conditions

Major Depressive Disorder

Interventions

R228060DRUG
Placebo and ParoxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

JJ PRD Research Center

Titusville, New Jersey, 08560, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2003

First Posted

November 19, 2003

Study Completion

May 1, 2004

Last Updated

August 28, 2009

Record last verified: 2004-05

Locations

US(1)