Lethargic Depression Study
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
1 other identifier
interventional
268
1 country
24
Brief Summary
This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2003
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 8, 2003
CompletedFirst Posted
Study publicly available on registry
July 10, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedMay 30, 2017
May 1, 2017
1.9 years
July 8, 2003
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Secondary Outcomes (1)
Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (24)
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Sherman Oaks, California, 91403, United States
GSK Investigational Site
Temecula, California, 92591, United States
GSK Investigational Site
Denver, Colorado, 80212, United States
GSK Investigational Site
Cromwell, Connecticut, 06416, United States
GSK Investigational Site
Hamden, Connecticut, 06518, United States
GSK Investigational Site
Middletown, Connecticut, 06457, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
Cedar Rapids, Iowa, 52401, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Farmington Hills, Michigan, 48336, United States
GSK Investigational Site
Ridgeland, Mississippi, 39157, United States
GSK Investigational Site
Moorestown, New Jersey, 08057, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Beachwood, Ohio, 44122, United States
GSK Investigational Site
Portland, Oregon, 97201, United States
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208, United States
GSK Investigational Site
Austin, Texas, 78746, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Lake Jackson, Texas, 77566, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (3)
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.
RESULTJefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.
PMID: 16848645RESULTRush 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.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2003
First Posted
July 10, 2003
Study Start
June 1, 2003
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
May 30, 2017
Record last verified: 2017-05