NCT00057226

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
365

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

March 27, 2003

Last Update Submit

April 15, 2015

Conditions

Depressive Disorder, Major

Keywords

GW353162,Major depressive disorder,flexible

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 the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the 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

Cerritos, California, 90703, United States

Location

GSK Investigational Site

San Diego, California, 92108, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Boynton Beach, Florida, 33437, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Marietta, Georgia, 30060, United States

Location

GSK Investigational Site

Libertyville, Illinois, 60048, United States

Location

GSK Investigational Site

Oakbrook Terrace, Illinois, 60181, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Lafayette, Indiana, 47905, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71101, United States

Location

GSK Investigational Site

Rockville, Maryland, 20852, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Toledo, Ohio, 43623, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38119, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229-3815, United States

Location

GSK Investigational Site

Bellevue, Washington, 98004, 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, 2004

Study Completion

April 1, 2004

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(21)