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Bupropion for Depression in ESRD Patients on Hemodialysis

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ClinicalTrials.gov Identifier: NCT02238977
Recruitment Status : Terminated (Study stopped due to difficulty recruiting)
First Posted : September 12, 2014
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Arkansas

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:

  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.

Condition or disease Intervention/treatment Phase
Major Depression End Stage Renal Disease Drug: Fluoxetine Drug: Bupropion Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bupropion for Depression in ESRD Patients on Hemodialysis
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Fluoxetine
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.
Drug: Fluoxetine
Antidepressant
Other Name: Prozac

Experimental: Bupropion
Bupropion sustained release (SR) 150 mg orally twice per week
Drug: Bupropion
Antidepressant
Other Name: Wellbutrin SR




Primary Outcome Measures :
  1. Depression Severity [ Time Frame: up to 12 weeks ]

    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.




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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238977


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Informed Consent Form  [PDF] March 10, 2017


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02238977     History of Changes
Other Study ID Numbers: 203076
R21DK097470 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2014    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018
Last Verified: May 2018

Keywords provided by University of Arkansas:
depression
ESRD
hemodialysis

Additional relevant MeSH terms:
Depression
Depressive Disorder
Kidney Failure, Chronic
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Bupropion
Fluoxetine
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Serotonin Agents