Lethargic Depression Study
Phase 3
Completed
- Conditions
- EpilepsyMajor Depressive Disorder (MDD)
- Registration Number
- NCT00064467
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
- Secondary Outcome Measures
Name Time Method Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie bupropion's efficacy in treating lethargic symptoms of MDD?
How does extended-release bupropion compare to SSRIs in managing energy deficits in MDD patients?
Are there specific biomarkers that predict response to bupropion in MDD with lethargic symptoms?
What are the potential adverse events associated with high-dose bupropion in MDD treatment?
What is the role of norepinephrine and dopamine reuptake inhibition in bupropion's antidepressant effects?
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸San Antonio, Texas, United States
GSK Investigational Site🇺🇸San Antonio, Texas, United States