An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: March 27, 2003
Last updated: April 15, 2015
Last verified: April 2015
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)

Condition Intervention Phase
Depressive Disorder, Major
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 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.

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 the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study

Enrollment: 365
Study Start Date: March 2003
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00057226

  Show 21 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00057226     History of Changes
Other Study ID Numbers: OHB20003
Study First Received: March 27, 2003
Last Updated: April 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Major depressive disorder,

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders processed this record on November 24, 2015