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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00057239
First received: March 27, 2003
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder (MDD)
Drug: Radafaxine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 546
Study Start Date: March 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Radafaxine
    Other Name: Radafaxine
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057239

  Show 29 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, M.D. GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00057239     History of Changes
Other Study ID Numbers: OHB20001
Study First Received: March 27, 2003
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW353162
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014