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An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00057226
First received: March 27, 2003
Last updated: April 11, 2013
Last verified: March 2011
History of Changes
  Purpose

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.

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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

Estimated Enrollment: 364
Study Start Date: March 2003
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: NCT00057226

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00057226     History of Changes
Other Study ID Numbers: OHB20003
Study First Received: March 27, 2003
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW353162,
Major depressive disorder,
flexible

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

ClinicalTrials.gov processed this record on May 19, 2013