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

Tracking Information

First Received Date ^ICMJE

March 27, 2003

Last Updated Date

October 13, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00057239 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Major Depressive Disorder (MDD)

Intervention ^ICMJE

Drug: Radafaxine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

546

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00057239

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

OHB20001

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP