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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00057239

Collaborator

(none)

546

Enrollment

Locations

Duration (Months)

18.8

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	Drug: Radafaxine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2003

Actual Primary Completion Date :

May 1, 2004

Actual Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

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

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. [8 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Little Rock	Arkansas	United States	72223
2	GSK Investigational Site	Newport Beach	California	United States	92660-2814
3	GSK Investigational Site	Farmington	Connecticut	United States	6708
4	GSK Investigational Site	Largo	Florida	United States	33773
5	GSK Investigational Site	Maitland	Florida	United States	32751
6	GSK Investigational Site	Miami	Florida	United States	33156
7	GSK Investigational Site	North Miami	Florida	United States	33161
8	GSK Investigational Site	Edwardsville	Illinois	United States	62025
9	GSK Investigational Site	Glen Burnie	Maryland	United States	21061
10	GSK Investigational Site	Farmington Hills	Michigan	United States	48336
11	GSK Investigational Site	Minneapolis	Minnesota	United States	55454
12	GSK Investigational Site	Clementon	New Jersey	United States	08021
13	GSK Investigational Site	Kenilworth	New Jersey	United States	07033
14	GSK Investigational Site	Lawrence	New York	United States	11559
15	GSK Investigational Site	Charlotte	North Carolina	United States	28203
16	GSK Investigational Site	Cleveland	Ohio	United States	44106
17	GSK Investigational Site	Dayton	Ohio	United States	45408
18	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73118
19	GSK Investigational Site	Eugene	Oregon	United States	97401
20	GSK Investigational Site	Portland	Oregon	United States	97209
21	GSK Investigational Site	Portland	Oregon	United States	97210
22	GSK Investigational Site	Conshohocken	Pennsylvania	United States	19428
23	GSK Investigational Site	Dallas	Texas	United States	75235
24	GSK Investigational Site	Houston	Texas	United States	77004
25	GSK Investigational Site	Irving	Texas	United States	75039
26	GSK Investigational Site	Woodstock	Vermont	United States	05091
27	GSK Investigational Site	Seattle	Washington	United States	98104
28	GSK Investigational Site	Tacoma	Washington	United States	98499
29	GSK Investigational Site	Brown Deer	Wisconsin	United States	53223