Bupropion for Fatigue in Kidney Failure
(BRISK Trial)
Recruiting in Palo Alto (17 mi)
Overseen bySubrata Debnath, MB.BS., Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Must not be taking: Bupropion, Antidepressants, MAO inhibitors
Disqualifiers: Eating disorders, Seizure, Depression, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients.
In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on bupropion or antidepressants.
What evidence supports the effectiveness of the drug bupropion for reducing fatigue in patients with kidney failure?
Research shows that bupropion can significantly reduce fatigue in cancer patients, suggesting it might also help with fatigue in kidney failure. In studies, patients taking bupropion reported feeling less tired and had improved quality of life.
12345Is bupropion generally safe for humans?
Bupropion, used under various names like Wellbutrin and Zyban, has been studied in clinical trials for different conditions, including depression and cancer-related fatigue. These studies generally found that bupropion was well-tolerated with minimal adverse effects, suggesting it is generally safe for human use.
13456How is the drug Bupropion unique for treating fatigue in kidney failure?
Bupropion is unique for treating fatigue in kidney failure because it is primarily an antidepressant that works by affecting neurotransmitters (chemical messengers in the brain), which may help alleviate fatigue differently than other treatments like physical activity or erythropoiesis-stimulating agents. Unlike these other treatments, Bupropion's mechanism targets brain chemistry, potentially offering a novel approach to managing fatigue in this population.
7891011Eligibility Criteria
This trial is for end-stage kidney disease patients who experience fatigue while on maintenance hemodialysis. Participants should be currently undergoing routine dialysis and willing to take bupropion tablets during their sessions.Inclusion Criteria
Blood hemoglobin of ≥10.0 g/dL based on most recent routine laboratory profile
Dialysis adequacy measured with Kt/V of ≥1.2
Ability to understand and the willingness to sign a written informed consent document
+1 more
Exclusion Criteria
I have had long-term effects after recovering from COVID-19.
Diagnosis of cognitive impairment including dementia
Current participation in another interventional trial
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete questionnaires and provide biological specimens.
8 weeks
3 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if bupropion, a medication used for depression and to quit smoking, can reduce fatigue in hemodialysis patients. It involves taking the drug three times a week for eight weeks during dialysis, along with completing questionnaires about fatigue and quality of life.
1Treatment groups
Experimental Treatment
Group I: Hemodialysis GroupExperimental Treatment1 Intervention
Fixed dose bupropion hydrochloride 150 mg extended-release tablets will be administered orally thrice a week during routine dialysis sessions for consecutive 8 weeks.
Bupropion is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇪🇺 Approved in European Union as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇨🇦 Approved in Canada as Zyban for:
- Smoking cessation
🇦🇺 Approved in Australia as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Hospital Dialysis Medical Center (DMC)San Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
References
An open-label study of the effects of bupropion SR on fatigue, depression and quality of life of mixed-site cancer patients and their partners. [2015]This preliminary study investigated whether bupropion sustained release (SR) improved symptomatic fatigue, depression and quality of life in cancer patients and caregiver quality of life. The sample consisted of a prospective open case series of 21 cancer patients, with fatigue and with or without depression at moderate to severe levels, referred for psychiatric assessment from a tertiary care cancer centre. Both patient symptom ratings and caregiver ratings were measured before and after 4 weeks of treatment with the maximally tolerated dose of bupropion in the range of 100-300 mg per day. At trial completion, significant improvement was found for symptoms of fatigue and depression. Subjects were divided into two groups: depressed and non-depressed (based on a cut-off score of 17 on the Hamilton Depression Rating Scale). Both groups reported improvement for fatigue and depressive symptoms. Depressed subjects and their caregivers did not experience any change in quality of life, while the non-depressed subjects and their caregivers reported improvements. Results from this small group of patients suggest that bupropion may have potential as an effective pharmaceutical agent for treating cancer-related fatigue. A randomized, placebo-controlled trial with this medication is indicated.
Assessment of Potential In vitro Genotoxic and Cytotoxic Effects of Bupropion Hydrochloride (Wellbutrin) in Human Peripheral Lymphocytes and Human Cortical Neuron. [2021]Wellbutrin (bupropion hydrochloride; WB), an anti-depressant of the aminoketone class is new highly selective norepinephrine and dopamine reuptake inhibitor; it is effective in the treatment of patients with major depression.
Potential Role of Bupropion Sustained Release for Cancer-Related Fatigue: a Double-Blind, Placebo-Controlled Study [2018]Background: Cancer-related fatigue (CRF) is very common and can be experienced at all stages of disease and in survivors. CRF causes patients more distress than pain or nausea and vomiting. Different pharmacologic interventions have been evaluated for the management of CRF. The purpose of this study was to determine the efficacy of bupropion sustained release (SR) as a treatment for fatigue in patients with cancer. Methods: In this randomized, double-blind, placebo-controlled trial, patients with fatigue due to cancer were randomly assigned to either 150mg daily of bupropion SR or matching placebo. The primary endpoint was the changes in average daily fatigue from baseline to week 4 using the Functional Assessment of Chronic Illness-therapy- Fatigue (FACIT-F) questionnaire. Results: 40 patients were randomly assigned to treatment with bupropion SR or placebo (20 in each group). Analysis of covariance (ANCOVA) showed a significant improvement in fatigue and quality of life in the bupropion group compared to baseline (P=0.000). Secondary outcome, including depression, severity of fatigue and performance status didn’t show significant difference between groups. Generally, bupropion SR was tolerated well. Conclusion: Four weeks of 150 mg bupropion SR improve fatigue significantly in cancer patients. Bupropion has potential as an effective and safe pharmaceutical agent for treating CRF.
Bupropion sustained release treatment reduces fatigue in cancer patients. [2017]To demonstrate that bupropion sustained release (SR) can reduce the symptoms of fatigue experienced by cancer patients.
Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. [2019]This multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of extended-release bupropion (bupropion XL) in the treatment of major depressive disorder (MDD) with prominent symptoms of decreased energy, pleasure, and interest.
Methodologic approach to adverse events applied to bupropion clinical trials. [2013]A strategy for identifying and classifying adverse events and for assessing their relationship to therapy and frequency of occurrence is presented. Data from clinical trials of bupropion (Wellbutrin), a novel antidepressant, are presented as an example. Bupropion was studied in four double-blind, placebo-controlled trials (N = 360) at dosages of 300-750 mg/day. The incidence and frequency of adverse events associated with bupropion were minimal, and correlated well with the known pharmacologic and clinical properties of this new antidepressant.
Psychometric Properties of the Brief Fatigue Inventory in Hemodialysis Patients during a Dialysis Day: A Preliminary Report. [2023]The aim of this study was to evaluate the psychometric properties of the Brief Fatigue Inventory (BFI) in hemodialysis patients. During a dialysis day, patients completed both 9-item BFI and 21-item Beck Depression Inventory (BDI)-II questionnaires. The psychometric properties of the BFI were assessed in terms of reliability and validity. The BFI had an overall Cronbach's coefficient alpha of .92. Inter-item correlation coefficients between BFI items ranged from .38 to. 81 (all p < .0001). Exploratory factor analysis revealed bidimensional factor structure of the BFI-fatigue "severity" and fatigue "interference" explaining 11.0% and 62.0% of the total variance in the data set, respectively. In criterion validity analysis, BFI composite score correlated significantly with the total BDI-II score-Pearson correlation coefficient .40 (p < .0001). These preliminary results support the satisfactory psychometric properties of the BFI in assessing fatigue among hemodialysis patients during a dialysis day in a clinic setting.
'It's when you're not doing too much you feel tired': A qualitative exploration of fatigue in end-stage kidney disease. [2023]Fatigue is commonly experienced in end-stage kidney disease (ESKD) patients. In order to develop patient-centred psychosocial interventions to help patients manage fatigue symptoms, a more in-depth understanding regarding the experience of fatigue is needed.
Cognitive-behavioural therapy (CBT) for renal fatigue (BReF): a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients. [2018]Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients.
Fatigue in Patients with Chronic Kidney Disease: Evidence and Measures. [2018]As many as 70% to 97% of individuals with chronic kidney disease (CKD) report fatigue. Fatigue is one of the common, troubling symptoms that affects one's quality of life. This narrative review summarizes the evidence and gaps about the epidemiology, causative factors, and assessment of fatigue in individuals with CKD. Most studies are focused on the hemodialysis population, with very few focused on the peritoneal dialysis and transplant populations in which fatigue is also prevalent. Understanding fatigue and its correlates can help in assessing fatigue and in implementing interventions to alleviate fatigue.
Fatigue in CKD: Epidemiology, Pathophysiology, and Treatment. [2023]Fatigue is a commonly reported and debilitating symptom among patients with CKD, yet little is known about its epidemiology, pathogenesis, and treatment. Various measurement tools have been used in published studies to identify and quantify fatigue. These include several single-item measures embedded in longer questionnaires for assessing depression, quality of life, or symptom burden in patients with kidney disease. Approximately 70% of patients with CKD report fatigue, with up to 25% reporting severe symptoms. Patient-reported fatigue is associated with death, dialysis initiation, and hospitalization among individuals with CKD. The pathophysiology is multifactorial and likely includes decreased oxygen delivery and increased reliance on anaerobic metabolism, thus generating lactic acidosis in response to exertion; the effects of chronic metabolic acidosis and hyperphosphatemia on skeletal muscle myocytes; protein-energy wasting and sarcopenia; and depression. Physical activity has been shown to improve fatigue in some small but promising trials, and so should be recommended, given the additional benefits of exercise. Targeting higher hemoglobin levels with erythropoiesis-stimulating agents may improve fatigue, but potential adverse cardiovascular effects preclude their use to solely treat fatigue without the presence of another indication. Current guidelines recommend cautious individualization of hemoglobin targets for those at low cardiovascular risk who still experience fatigue or functional limitation despite a hemoglobin level of 10 g/dl. Sodium bicarbonate supplementation for the treatment of metabolic acidosis may also improve functional status. Selective serotonin reuptake inhibitors have not been consistently shown to improve fatigue in patients with kidney disease, but an ongoing trial will evaluate the effect of alternative antidepressant drug and behavioral activation therapy on fatigue in patients with CKD. Overall, more research is needed to further clarify underlying mechanisms of fatigue and identify effective, targeted treatments for patients with CKD.