Last updated: 11/04/2018 04:36:01
Lethargic Depression Study
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Extended-release bupropion (HCl)
Enrollment:
268
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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.
Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for major depressive disorder with symptoms of reduced energy, pleasure, and interest: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry, 2006; 67:865-873
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.
Medical condition
Epilepsy, Major Depressive Disorder (MDD)
Product
bupropion
Collaborators
Not applicable
Study date(s)
June 2003 to May 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.
- Generally in good health.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Cromwell, Connecticut, United States, 06416
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
Status
Study Complete
Location
GSK Investigational Site
Middletown, Connecticut, United States, 06457
Status
Study Complete
Location
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
Status
Study Complete
Location
GSK Investigational Site
Ridgeland, Mississippi, United States, 39157
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80212
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97201
Status
Study Complete
Location
GSK Investigational Site
Hamden, Connecticut, United States, 06518
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
Status
Study Complete
Location
GSK Investigational Site
Cedar Rapids, Iowa, United States, 52401
Status
Study Complete
Location
GSK Investigational Site
Temecula, California, United States, 92591
Status
Study Complete
Location
GSK Investigational Site
Sherman Oaks, California, United States, 91403
Status
Study Complete
Location
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-31-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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