NCT00057213

Brief Summary

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication 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
367

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Typical duration for phase_2

Geographic Reach
1 country

21 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
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

4.1 years

First QC Date

March 27, 2003

Last Update Submit

April 15, 2015

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder (MDD),FlexibleGW353162,

Outcome Measures

Primary Outcomes (1)

  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS) 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, fatigue and pain;incidence of adverse events over course of study;

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 (21)

GSK Investigational Site

Peoria, Arizona, 85381 - 4828, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85251, United States

Location

GSK Investigational Site

Garden Grove, California, 92845, United States

Location

GSK Investigational Site

Irvine, California, 92618, United States

Location

GSK Investigational Site

National City, California, 91950, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Winter Park, Florida, 32789, United States

Location

GSK Investigational Site

Springfield, Illinois, 62702, United States

Location

GSK Investigational Site

Terre Haute, Indiana, 47802, United States

Location

GSK Investigational Site

Florence, Kentucky, 41042, United States

Location

GSK Investigational Site

Brockton, Massachusetts, 2301, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27514, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Lyndhurst, Ohio, 44124, United States

Location

GSK Investigational Site

Eugene, Oregon, 97401, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19106, United States

Location

GSK Investigational Site

Austin, Texas, 78756, United States

Location

GSK Investigational Site

Galveston, Texas, 77555, United States

Location

GSK Investigational Site

Lake Jackson, Texas, 77566, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

radafaxine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 27, 2003

First Posted

March 28, 2003

Study Start

March 1, 2003

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(21)