NCT00057239

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
546

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

March 27, 2003

Last Update Submit

October 1, 2010

Conditions

Major Depressive Disorder (MDD)

Keywords

GW353162Major Depressive DisorderMDD

Outcome Measures

Primary Outcomes (1)

  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment

    8 Weeks

Secondary Outcomes (1)

  • Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study.

    8 Weeks

Interventions

RadafaxineDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

GSK Investigational Site

Little Rock, Arkansas, 72223, United States

Location

GSK Investigational Site

Newport Beach, California, 92660-2814, United States

Location

GSK Investigational Site

Farmington, Connecticut, 6708, United States

Location

GSK Investigational Site

Largo, Florida, 33773, United States

Location

GSK Investigational Site

Maitland, Florida, 32751, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

North Miami, Florida, 33161, United States

Location

GSK Investigational Site

Edwardsville, Illinois, 62025, United States

Location

GSK Investigational Site

Glen Burnie, Maryland, 21061, United States

Location

GSK Investigational Site

Farmington Hills, Michigan, 48336, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55454, United States

Location

GSK Investigational Site

Clementon, New Jersey, 08021, United States

Location

GSK Investigational Site

Kenilworth, New Jersey, 07033, United States

Location

GSK Investigational Site

Lawrence, New York, 11559, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28203, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Dayton, Ohio, 45408, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73118, United States

Location

GSK Investigational Site

Eugene, Oregon, 97401, United States

Location

GSK Investigational Site

Portland, Oregon, 97209, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Conshohocken, Pennsylvania, 19428, United States

Location

GSK Investigational Site

Dallas, Texas, 75235, United States

Location

GSK Investigational Site

Houston, Texas, 77004, United States

Location

GSK Investigational Site

Irving, Texas, 75039, United States

Location

GSK Investigational Site

Woodstock, Vermont, 05091, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Tacoma, Washington, 98499, United States

Location

GSK Investigational Site

Brown Deer, Wisconsin, 53223, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

radafaxine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • GSK Clinical Trials, M.D.

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2003

First Posted

March 28, 2003

Study Start

March 1, 2003

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(29)