End Stage Renal Disease Clinical Trial
Official title:
Bupropion for Depression in ESRD Patients on Hemodialysis
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.
n/a
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