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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: Clinical Trial Phase 4 study, sponsored by University of Arkansas.
NCT02238977 is a Phase 4 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 (ext
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 |
Why NCT02238977 stopped before completion
NCT02238977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine is the first listed.
NCT02238977 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02238977's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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