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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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R228060

Intervention Type DRUG

Placebo and Paroxetine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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JJ PRD Research Center

Titusville, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CR004339

Identifier Type: -

Identifier Source: org_study_id