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

Phase 2

Completed

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT00057239
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-03-27
• Study First Submitted QC: 2003-03-27
• Study First Posted: 2003-03-28
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-01
• Last Update Posted: 2010-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Brown Deer, Wisconsin, United States