An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder

NCT ID: NCT00057226

Last Updated: 2015-04-16

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

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-04-30

Brief Summary

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

Detailed Description

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Conditions

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Depressive Disorder, Major

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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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Cerritos, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Washington D.C., District of Columbia, United States

Site Status

GSK Investigational Site

Boynton Beach, Florida, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

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GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Marietta, Georgia, United States

Site Status

GSK Investigational Site

Libertyville, Illinois, United States

Site Status

GSK Investigational Site

Oakbrook Terrace, Illinois, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Lafayette, Indiana, United States

Site Status

GSK Investigational Site

Shreveport, Louisiana, United States

Site Status

GSK Investigational Site

Rockville, Maryland, United States

Site Status

GSK Investigational Site

Saint Charles, Missouri, United States

Site Status

GSK Investigational Site

Albuquerque, New Mexico, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Toledo, Ohio, United States

Site Status

GSK Investigational Site

Memphis, Tennessee, United States

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GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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OHB20003

Identifier Type: -

Identifier Source: org_study_id

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