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Lethargic Depression Study

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 8, 2003
Last updated: May 24, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An 8 Week, Multicenter, Randomized, Double-blind, Placebo Controlled Comparison of the Efficacy of Extended Release Bupropion Hydrochloride and Placebo in the Treatment of Adult Outpatients With Major Depressive Disorder With Lethargic Symptoms

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)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00064467

  Hide Study 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
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

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.
Rush J, VanMeter SA, Wightman DS, Hampton KD, Krishen A, Modell JG. Bupropion XL for the treatment of adults with major depressive disorder. 45th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting, Boca Raton, FL, 6-9June, 2005.

Responsible Party: GlaxoSmithKline Identifier: NCT00064467     History of Changes
Other Study ID Numbers: AK130931
Study First Received: July 8, 2003
Last Updated: May 24, 2017

Keywords provided by GlaxoSmithKline:
decreased interest
decreased motivation

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on September 19, 2017