<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02238977</url>
  </required_header>
  <id_info>
    <org_study_id>203076</org_study_id>
    <secondary_id>R21DK097470</secondary_id>
    <nct_id>NCT02238977</nct_id>
  </id_info>
  <brief_title>Bupropion for Depression in ESRD Patients on Hemodialysis</brief_title>
  <official_title>Bupropion for Depression in ESRD Patients on Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will evaluate the response and remission rates for major depressive&#xD;
      disorder (MDD) in end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis&#xD;
      (HD) treated with bupropion or fluoxetine for 12 weeks. In addition, the study will document&#xD;
      the relative tolerability and safety, and longitudinally contrast the effects of bupropion&#xD;
      and fluoxetine on measures of cognitive function, fatigue, inflammation, and tryptophan (TRP)&#xD;
      and TRP catabolites in blood. It is hypothesized that both drugs will significantly reduce&#xD;
      MDD symptoms from baseline, and be tolerable and safe, but bupropion will be associated with&#xD;
      greater reduction in pro-inflammatory cytokines, cognitive impairment, and fatigue compared&#xD;
      with fluoxetine.&#xD;
&#xD;
      The Specific Aims of this study are:&#xD;
&#xD;
      Aim 1: Determine the efficacy of bupropion and fluoxetine in treatment of MDD in ESRD/HD&#xD;
      patients.&#xD;
&#xD;
      Aim 2: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and&#xD;
      fatigue differ between bupropion and fluoxetine.&#xD;
&#xD;
      Aim 3: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and&#xD;
      fatigue correlate with change in inflammation, measures of TRP availability to brain, or&#xD;
      neurotoxic TRP metabolites.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Bupropion and fluoxetine will both show efficacy in treating MDD;&#xD;
&#xD;
        2. Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than&#xD;
           fluoxetine; and&#xD;
&#xD;
        3. Change in cognition and fatigue over time will correlate with change in c-reactive&#xD;
           protein (CRP) and quinolinic acid and change in overall depression score will correlate&#xD;
           with measures of TRP availability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study stopped due to difficulty recruiting&#xD;
  </why_stopped>
  <start_date type="Actual">March 31, 2016</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression Severity</measure>
    <time_frame>up to 12 weeks</time_frame>
    <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 &gt; 17 is considered compatible with a diagnosis of major depression. A score &lt; 10 is considered clinical remission.&#xD;
The interview and scoring takes about 15 minutes.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Major Depression</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Fluoxetine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupropion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupropion sustained release (SR) 150 mg orally twice per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine</intervention_name>
    <description>Antidepressant</description>
    <arm_group_label>Fluoxetine</arm_group_label>
    <other_name>Prozac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion</intervention_name>
    <description>Antidepressant</description>
    <arm_group_label>Bupropion</arm_group_label>
    <other_name>Wellbutrin SR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 30-70 yrs;&#xD;
&#xD;
          -  have patent and non-infected arteriovenous fistula or graft;&#xD;
&#xD;
          -  are receiving maintenance HD 3 times per week lasting for 3-4 hours;&#xD;
&#xD;
          -  serum albumin of ≥ 3.2 g/dl, serum phosphate of &lt;6.5 mg/dl, and serum hemoglobin of ≥9&#xD;
             mg/dl in consecutive two blood tests as per the National Kidney Foundation Disease&#xD;
             Outcomes Quality Initiative (NKF KDOQI) guidelines [subjects failing screening due to&#xD;
             blood test will be allowed to be re-screened in 30 days];&#xD;
&#xD;
          -  receiving stable or maintenance dose of iron or erythropoietin-stimulating agents,&#xD;
             statins, angiotension receptor blockers and/or angiotension converting enzyme&#xD;
             inhibitors, phosphate binders, vitamin D receptor analogs as these agents may&#xD;
             influence cytokines proposed in the study;&#xD;
&#xD;
          -  meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)&#xD;
             criteria for MDD;&#xD;
&#xD;
          -  have a Ham-D score &gt; 17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  meet DSM-IV criteria for Bipolar Disorder or other psychotic disorder in the month&#xD;
             prior to screening;&#xD;
&#xD;
          -  are taking antidepressants, anti-anxiety medications, or hypnotics (including Zyban&#xD;
             for smoking cessation);&#xD;
&#xD;
          -  having failed to respond to or tolerate bupropion or fluoxetine in the past&#xD;
&#xD;
          -  allergic to fluoxetine or bupropion&#xD;
&#xD;
          -  known history of HIV/AIDS; No testing will be conducted for screening purposes&#xD;
&#xD;
          -  known history of alcohol or drug abuse or dependence within the month prior to&#xD;
             screening based on clinical records;&#xD;
&#xD;
          -  history of myocardial infarction or heart failure within one month of screening or a&#xD;
             history of seizures or stroke at any point;&#xD;
&#xD;
          -  history of chronic liver disease and diagnosis of hepatic encephalopathy based on&#xD;
             clinical records;&#xD;
&#xD;
          -  currently diagnosed with cancer or receiving any cancer treatment;&#xD;
&#xD;
          -  history of any infection within the last 2 weeks ;&#xD;
&#xD;
          -  currently taking any antibiotics, anti-inflammatory, and immune-modulator agents;&#xD;
&#xD;
          -  recorded noncompliance with dialysis schedules; and&#xD;
&#xD;
          -  currently participating in clinical or behavioral intervention studies.&#xD;
&#xD;
          -  recorded noncompliance with dialysis schedules; and&#xD;
&#xD;
          -  currently participating in clinical or behavioral intervention studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>April 2, 2018</results_first_submitted>
  <results_first_submitted_qc>July 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2018</results_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>ESRD</keyword>
  <keyword>hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02238977/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02238977/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fluoxetine</title>
          <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.&#xD;
Fluoxetine: Antidepressant</description>
        </group>
        <group group_id="P2">
          <title>Bupropion</title>
          <description>Bupropion sustained release (SR) 150 mg orally twice per week&#xD;
Bupropion: Antidepressant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Due to inability to recruit subjects study was terminated. Only one subject enrolled and completed.</population>
      <group_list>
        <group group_id="B1">
          <title>Fluoxetine</title>
          <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.&#xD;
Fluoxetine: Antidepressant</description>
        </group>
        <group group_id="B2">
          <title>Bupropion</title>
          <description>Bupropion sustained release (SR) 150 mg orally twice per week&#xD;
Bupropion: Antidepressant</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depression Severity</title>
        <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 &gt; 17 is considered compatible with a diagnosis of major depression. A score &lt; 10 is considered clinical remission.&#xD;
The interview and scoring takes about 15 minutes.</description>
        <time_frame>up to 12 weeks</time_frame>
        <population>Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Bupropion</title>
            <description>Bupropion sustained release (SR) 150 mg orally twice per week&#xD;
Bupropion: Antidepressant</description>
          </group>
          <group group_id="O2">
            <title>Fluoxetine</title>
            <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.&#xD;
Fluoxetine: Antidepressant</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Severity</title>
          <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 &gt; 17 is considered compatible with a diagnosis of major depression. A score &lt; 10 is considered clinical remission.&#xD;
The interview and scoring takes about 15 minutes.</description>
          <population>Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.</population>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 weeks</time_frame>
      <desc>Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fluoxetine</title>
          <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.&#xD;
Fluoxetine: Antidepressant</description>
        </group>
        <group group_id="E2">
          <title>Bupropion</title>
          <description>Bupropion sustained release (SR) 150 mg orally twice per week&#xD;
Bupropion: Antidepressant</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pedro Delgado, M.D.</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>501-526-8100</phone>
      <email>pldelgado@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238977
org study id: 203076
secondary id: R21DK097470
nct id: NCT02238977
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Depression Severity
time frame: up to 12 weeks
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.
arm group label: Fluoxetine
arm group type: Active Comparator
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 group label: Bupropion
arm group type: Experimental
description: Bupropion sustained release (SR) 150 mg orally twice per week
intervention type: Drug
intervention name: Fluoxetine
description: Antidepressant
arm group label: Fluoxetine
other name: Prozac
intervention type: Drug
intervention name: Bupropion
description: Antidepressant
arm group label: Bupropion
other name: Wellbutrin SR
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Bupropion
mesh term: Fluoxetine
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