Status:
TERMINATED
Bupropion for Depression in ESRD Patients on Hemodialysis
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Major Depression
End Stage Renal Disease
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief 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 b...
Eligibility Criteria
Inclusion
- age 30-70 yrs;
- have patent and non-infected arteriovenous fistula or graft;
- are receiving maintenance HD 3 times per week lasting for 3-4 hours;
- serum albumin of ≥ 3.2 g/dl, serum phosphate of \<6.5 mg/dl, and serum hemoglobin of ≥9 mg/dl in consecutive two blood tests as per the National Kidney Foundation Disease Outcomes Quality Initiative (NKF KDOQI) guidelines \[subjects failing screening due to blood test will be allowed to be re-screened in 30 days\];
- receiving stable or maintenance dose of iron or erythropoietin-stimulating agents, statins, angiotension receptor blockers and/or angiotension converting enzyme inhibitors, phosphate binders, vitamin D receptor analogs as these agents may influence cytokines proposed in the study;
- meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD;
- have a Ham-D score \> 17
Exclusion
- meet DSM-IV criteria for Bipolar Disorder or other psychotic disorder in the month prior to screening;
- are taking antidepressants, anti-anxiety medications, or hypnotics (including Zyban for smoking cessation);
- having failed to respond to or tolerate bupropion or fluoxetine in the past
- allergic to fluoxetine or bupropion
- known history of HIV/AIDS; No testing will be conducted for screening purposes
- known history of alcohol or drug abuse or dependence within the month prior to screening based on clinical records;
- history of myocardial infarction or heart failure within one month of screening or a history of seizures or stroke at any point;
- history of chronic liver disease and diagnosis of hepatic encephalopathy based on clinical records;
- currently diagnosed with cancer or receiving any cancer treatment;
- history of any infection within the last 2 weeks ;
- currently taking any antibiotics, anti-inflammatory, and immune-modulator agents;
- recorded noncompliance with dialysis schedules; and
- currently participating in clinical or behavioral intervention studies.
- recorded noncompliance with dialysis schedules; and
- currently participating in clinical or behavioral intervention studies
Key Trial Info
Start Date :
March 31 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02238977
Start Date
March 31 2016
End Date
March 1 2018
Last Update
July 17 2018
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205