Bupropion for Depression in ESRD Patients on Hemodialysis
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|ClinicalTrials.gov Identifier: NCT02238977|
Recruitment Status : Terminated (Study stopped due to difficulty recruiting)
First Posted : September 12, 2014
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
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)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bupropion for Depression in ESRD Patients on Hemodialysis|
|Actual Study Start Date :||March 31, 2016|
|Actual Primary Completion Date :||March 1, 2018|
|Actual Study Completion Date :||March 1, 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 [ Time Frame: up to 12 weeks ]
Depression severity as measured by the 25-item Hamilton Depression Rating Scale. The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient/participant and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score the more severe the depression. The scale is scored by summing the total of all items. The maximum possible total score is 66 and the minimum is 0. A score > 17 is considered compatible with a diagnosis of major depression. A score < 10 is considered clinical remission.
The interview and scoring takes about 15 minutes.
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
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|