Bupropion for Depression in ESRD Patients on Hemodialysis
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|ClinicalTrials.gov Identifier: NCT02238977|
Recruitment Status : Recruiting
First Posted : September 12, 2014
Last Update Posted : September 14, 2017
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.
- Bupropion and fluoxetine will both show efficacy in treating MDD;
- Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than fluoxetine; and
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression End Stage Renal Disease||Drug: Fluoxetine Drug: Bupropion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bupropion for Depression in ESRD Patients on Hemodialysis|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Fluoxetine
Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.
Other Name: Prozac
Bupropion sustained release (SR) 150 mg orally twice per week
Other Name: Wellbutrin SR
- Depression severity as measured by the 25-item Hamilton Depression Rating Scale [ Time Frame: up to 12 weeks ]
- Cognitive function as measured by Attention Switching Task of the Cambridge Neuropsychological Test Automated Battery [ Time Frame: Baseline and at weeks 4 and 12 of treatment ]
- Cognitive function as measured by the Modified Mini Mental Status (3MS) examination [ Time Frame: Baseline and at weeks 4 and 12 of treatment ]
- Clinical Global Impressions - Severity [ Time Frame: Baseline and weekly for 12 weeks ]
- Clinical Global Impressions Scale - Improvement [ Time Frame: Baseline and weekly for 12 weeks ]
- Tolerability as measured by Systematic Assessment for Treatment Emergent Events [ Time Frame: Baseline and weekly for 12 weeks ]
- Fatigue as measured by the Brief Fatigue Inventory [ Time Frame: Baseline and weekly for 12 weeks ]
- Subclinical changes in emotion and mood as measured by the Profile of Mood States rating scale [ Time Frame: Baseline and weekly for 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238977
|Contact: Pedro L Delgado, MDfirstname.lastname@example.org|
|Contact: Faye Smithemail@example.com|
|United States, Arkansas|
|University of Arkansas for Medical Sciences||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Pedro L Delgado, MD 501-526-8140 firstname.lastname@example.org|
|Principal Investigator: Pedro L Delgado, MD|
|Sub-Investigator: Michelle Krause, MD|
|Sub-Investigator: Alison Oliveto, Ph.D|
|Sub-Investigator: Andrew James, Ph.D.|