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

Primary Purpose

Major Depressive Disorder (MDD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radafaxine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder (MDD) focused on measuring GW353162, Major Depressive Disorder, MDD

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 27, 2003
Last Updated
October 1, 2010
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00057239
Brief Title
An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy, Safety and Tolerability of Two Doses (20mg and 60mg) of a Once-Daily Oral Formulation of GW353162 in Subjects With Major Depressive Disorder for a Treatment Period of Eight Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
Keywords
GW353162, Major Depressive Disorder, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
546 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Radafaxine
Primary Outcome Measure Information:
Title
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, M.D.
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
GSK Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660-2814
Country
United States
Facility Name
GSK Investigational Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
6708
Country
United States
Facility Name
GSK Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
GSK Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
GSK Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
GSK Investigational Site
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62025
Country
United States
Facility Name
GSK Investigational Site
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
GSK Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
GSK Investigational Site
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
GSK Investigational Site
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
GSK Investigational Site
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
GSK Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Investigational Site
City
Conshohocken
State/Province
Pennsylvania
ZIP/Postal Code
19428
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
GSK Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Facility Name
GSK Investigational Site
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
GSK Investigational Site
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States

12. IPD Sharing Statement

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

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