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Bupropion for Depression in ESRD Patients on Hemodialysis

Primary Purpose

Major Depression, End Stage Renal Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Bupropion
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, ESRD, hemodialysis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fluoxetine

Bupropion

Arm Description

Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.

Bupropion sustained release (SR) 150 mg orally twice per week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2014
Last Updated
July 16, 2018
Sponsor
University of Arkansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02238977
Brief Title
Bupropion for Depression in ESRD Patients on Hemodialysis
Official Title
Bupropion for Depression in ESRD Patients on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to difficulty recruiting
Study Start Date
March 31, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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: Bupropion and fluoxetine will both show efficacy in treating MDD; Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than fluoxetine; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, End Stage Renal Disease
Keywords
depression, ESRD, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Active Comparator
Arm Description
Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.
Arm Title
Bupropion
Arm Type
Experimental
Arm Description
Bupropion sustained release (SR) 150 mg orally twice per week
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Antidepressant
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin SR
Intervention Description
Antidepressant
Primary Outcome Measure Information:
Title
Depression Severity
Description
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.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Bupropion for Depression in ESRD Patients on Hemodialysis

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