An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder

NCT ID: NCT00057239

Last Updated: 2010-10-04

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

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-05-31

Brief Summary

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A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in Patients with Major Depressive Disorder (MDD)

Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Radafaxine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Major Depressive Disorder (MDD)
* Duration of current depressive episode 12 weeks - 24 months
* Patients can read and write at a level sufficient to provide a signed consent
* If female, patients must be practicing an acceptable method of birth control

Exclusion Criteria

* Patients have other psychiatric disorders that would affect patient's response to treatment
* Patients have not responded to two or more adequate courses of antidepressant therapy
* Patients cannot be currently abusing illicit drugs or alcohol
* Patients are not currently receiving psychotherapy
* Patients have received electroconvulsive therapy within 6 months prior to screening
* Patients are pregnant or lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, M.D.

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Newport Beach, California, United States

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GSK Investigational Site

Farmington, Connecticut, United States

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Largo, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Edwardsville, Illinois, United States

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Glen Burnie, Maryland, United States

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Farmington Hills, Michigan, United States

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Minneapolis, Minnesota, United States

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Clementon, New Jersey, United States

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Kenilworth, New Jersey, United States

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Lawrence, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Conshohocken, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Woodstock, Vermont, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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GSK Investigational Site

Brown Deer, Wisconsin, United States

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Countries

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United States

Other Identifiers

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OHB20001

Identifier Type: -

Identifier Source: org_study_id