Bupropion for Depression in ESRD Patients on Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

Bupropion for Depression in ESRD Patients on Hemodialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02238977
• Other study ID #: 203076
• Secondary ID: R21DK097470
• Status: Terminated
• Phase: Phase 4
• Start date: March 31, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• End Stage Renal Disease
• Kidney Failure, Chronic
• Major Depression

Intervention

Drug:
• Fluoxetine
Antidepressant
• Bupropion
Antidepressant

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Severity	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.	up to 12 weeks