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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073203

Enrollment

488

Registered

2003-11-19

Start date

Unknown

Completion date

2004-05-31

Last updated

2009-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

DRUGR228060

DRUGPlacebo and Paroxetine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026