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

NCT ID: NCT00057213

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

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-04-30

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

Peoria, Arizona, United States

Site Status

GSK Investigational Site

Scottsdale, Arizona, United States

Site Status

GSK Investigational Site

Garden Grove, California, United States

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GSK Investigational Site

Irvine, California, United States

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GSK Investigational Site

National City, California, United States

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GSK Investigational Site

Miami, Florida, United States

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GSK Investigational Site

Winter Park, Florida, United States

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GSK Investigational Site

Springfield, Illinois, United States

Site Status

GSK Investigational Site

Terre Haute, Indiana, United States

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GSK Investigational Site

Florence, Kentucky, United States

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GSK Investigational Site

Brockton, Massachusetts, United States

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GSK Investigational Site

New York, New York, United States

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GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Lyndhurst, Ohio, United States

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GSK Investigational Site

Eugene, Oregon, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, United States

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GSK Investigational Site

Austin, Texas, United States

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GSK Investigational Site

Galveston, Texas, United States

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GSK Investigational Site

Lake Jackson, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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OHB20002

Identifier Type: -

Identifier Source: org_study_id

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