NCT02238977

Bupropion for Depression in ESRD Patients on Hemodialysis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will evaluate the response and remission rates for major depressive disorder (MDD) in end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis (HD) treated with bupropion or fluoxetine for 12 weeks. In addition, the study will document the relative tolerability and safety, and longitudinally contrast the effects of bupropion and fluoxetine on measures of cognitive function, fatigue, inflammation, and tryptophan (TRP) and TRP catabolites in blood. It is hypothesized that both drugs will significantly reduce MDD symptoms from baseline, and be tolerable and safe, but bupropion will be associated with greater reduction in pro-inflammatory cytokines, cognitive impairment, and fatigue compared with fluoxetine. The Specific Aims of this study are: Aim 1: Determine the efficacy of bupropion and fluoxetine in treatment of MDD in ESRD/HD patients. Aim 2: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and fatigue differ between bupropion and fluoxetine. Aim 3: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and fatigue correlate with change in inflammation, measures of TRP availability to brain, or neurotoxic TRP metabolites. Hypotheses: 1. Bupropion and fluoxetine will both show efficacy in treating MDD; 2. Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than fluoxetine; and 3. Change in cognition and fatigue over time will correlate with change in c-reactive protein (CRP) and quinolinic acid and change in overall depression score will correlate with measures of TRP availability.

Conditions

• Major Depression
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Fluoxetine	Antidepressant
DRUG	Bupropion	Antidepressant

Timeline

• Start date: 2016-03-31
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2014-09-12
• Last updated: 2018-07-17
• Results posted: 2018-07-17

Locations

1 site across 1 country: United States