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Lethargic Depression Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00064467
First received: July 8, 2003
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.


Condition Intervention Phase
Epilepsy
Major Depressive Disorder (MDD)
Drug: Extended-release bupropion (HCl)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.

Secondary Outcome Measures:
  • Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.

Estimated Enrollment: 268
Study Start Date: June 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Extended-release bupropion (HCl)
    Other Name: Extended-release bupropion (HCl)
Detailed Description:

A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.
  • Generally in good health.
  • Subject must read and write at a level sufficient to provide written informed consent.

Exclusion criteria:

  • Current or past history of seizure disorder.
  • Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder.
  • Currently using illicit drugs or other psychotropic drugs.
  • Patient poses a current suicidal risk or has attempted suicide in the past 6 months.
  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 ClinicalTrials.gov identifier: NCT00064467

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90210
GSK Investigational Site
Sherman Oaks, California, United States, 91403
GSK Investigational Site
Temecula, California, United States, 92591
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80212
United States, Connecticut
GSK Investigational Site
Cromwell, Connecticut, United States, 06416
GSK Investigational Site
Hamden, Connecticut, United States, 06518
GSK Investigational Site
Middletown, Connecticut, United States, 06457
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33156
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
United States, Iowa
GSK Investigational Site
Cedar Rapids, Iowa, United States, 52401
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
United States, Mississippi
GSK Investigational Site
Ridgeland, Mississippi, United States, 39157
United States, New Jersey
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, Ohio
GSK Investigational Site
Beachwood, Ohio, United States, 44122
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97201
United States, Rhode Island
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78746
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
GSK Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Publications:
Rush J, VanMeter SA, Wightman D, Hampton KD, Krishen A, Modell JG. Wellbutrin XL for the treatment of adults with major depressive disorder. American Psychiatric Association 158th Annual Meeting, Atlanta, GA, 21-26 May, 2005, Abstract No. 787.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00064467     History of Changes
Other Study ID Numbers: AK130931
Study First Received: July 8, 2003
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
lethargic
decreased interest
decreased motivation
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014