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NCT02238977 · ClinicalTrials.gov registry record · Phase 4
Bupropion for Depression in ESRD Patients on Hemodialysis
A Phase 4 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT02238977 is a Phase 4 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 1 participants.
The verdict
NCT02238977, a Phase 4 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study 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.
Interventions
- DRUG Fluoxetine
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-03-31 |
| Est. Completion | 2018-03-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02238977
The ClinicalTrials.gov registry entry for NCT02238977 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine is the first listed.
NCT02238977 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02238977 about?
NCT02238977 is a clinical study titled "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 ...
What is the current status of trial NCT02238977?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2016-03-31. Estimated completion is 2018-03-01.
What interventions are being tested in trial NCT02238977?
The interventions under investigation include: Fluoxetine (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT02238977?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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