<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/NCT02209597</url>
  </required_header>
  <id_info>
    <org_study_id>201312021</org_study_id>
    <nct_id>NCT02209597</nct_id>
  </id_info>
  <brief_title>Clinical Study of Generic and Brand Bupropion in Depression</brief_title>
  <acronym>BALANCE</acronym>
  <official_title>Bioequivalence and Clinical Effects of Generic and Brand Bupropion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine bioequivalence between branded and generic bupropion extended release (XL) products&#xD;
      (and between generic products) at steady state in patients with major depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol is a prospective, randomized, double-blinded, crossover study with Major&#xD;
      Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).&#xD;
&#xD;
      Subjects will be studied in 4 phases for a total of approximately 28 weeks:&#xD;
&#xD;
      Phase 1: an approximately 4-week lead-in phase during which participants remain on their&#xD;
      existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6&#xD;
      weeks on each of the four bupropion study drugs (brand and 3 generics).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2014</start_date>
  <completion_date type="Actual">August 14, 2016</completion_date>
  <primary_completion_date type="Actual">August 14, 2016</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Each participant receives the 4 drugs in sequence (sequence is randomized).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>The randomization table will be generated by the Barnes-Jewish Hospital Investigational Pharmacy. Each subject will be assigned the next available number. Subjects, investigators, and all study team members will be blinded to drug treatment. In the case of dropouts (either subject- or investigator-initiated), subjects will be replaced, to provide the required number of subjects.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion</measure>
    <time_frame>For 24 hours approximately every 6 weeks</time_frame>
    <description>Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>StudyArm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be studied for 28 weeks in a sequential cross-over study: a&#xD;
Subjects will be studied in 4 phases for a total of approximately 28 weeks:&#xD;
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion XL 300</intervention_name>
    <description>Subjects will be studied in 4 phases for a total of approximately 28 weeks:&#xD;
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
    <arm_group_label>StudyArm</arm_group_label>
    <other_name>Wellbutrin</other_name>
    <other_name>Par</other_name>
    <other_name>Mylan</other_name>
    <other_name>Valeant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Each subject must meet all of the following criteria:&#xD;
&#xD;
          1. Adult outpatients age 18-75 years&#xD;
&#xD;
          2. Currently on once daily bupropion HCl 300mg XL (brand or any generic), for a minimum&#xD;
             of 4 months&#xD;
&#xD;
          3. Major depressive disorder (MDD), in partial or full remission for at least 4 months,&#xD;
             as confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID).&#xD;
             Spontaneous relapse of depression unrelated to medication changes is less likely -&#xD;
             about 5% chance per year - after remission has been maintained for at least 4 months.2&#xD;
&#xD;
          4. Ability to understand and willingness to comply with study procedures, and to provide&#xD;
             written informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subjects will not be enrolled if any of the following criteria exist:&#xD;
&#xD;
          1. Remission from depression not clearly attributed to bupropion treatment&#xD;
&#xD;
          2. Current severe side effects attributable to bupropion&#xD;
&#xD;
          3. Poor adherence to bupropion treatment per patient self- report and history of refill&#xD;
             persistence&#xD;
&#xD;
          4. History of active seizure disorder, or seizure treatment within past year&#xD;
&#xD;
          5. History of significant hepatic or renal disease, based on physician assessment&#xD;
&#xD;
          6. Currently taking drugs or natural products known to influence cytochrome P450B6&#xD;
             (CYP2B6) activity&#xD;
&#xD;
          7. Currently taking drugs for hepatitis C or multiple sclerosis, due to their ability to&#xD;
             cause depression&#xD;
&#xD;
          8. Dementia or other significant cognitive impairment, per diagnosis or investigative&#xD;
             team's assessment&#xD;
&#xD;
          9. Lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order,&#xD;
             delusional disorder, or current psychotic symptoms diagnosed by SCID&#xD;
&#xD;
         10. Abuse of or dependence on alcohol or other substances within the past 6 months as&#xD;
             determined by SCID, and confirmed by study physician interview&#xD;
&#xD;
         11. Current suicidal ideation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evan D Kharasch, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington Univesity School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>June 20, 2018</results_first_submitted>
  <results_first_submitted_qc>April 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2020</results_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>bupropion XL</keyword>
  <keyword>Wellbutrin XL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion</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>November 19, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02209597/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bupropion</title>
          <description>Phase 1: (Non-randomized) an approximately 4-week lead-in phase during which participants remain on their existing bupropion product&#xD;
Other Names:&#xD;
Wellbutrin Par Mylan Valeant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase 1 Current Tx (Non-randomized)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 2 (Randomized: 1 Brand, 3 Generic)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 3 (Randomized: 1 Brand, 3 Generic)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Phase 4 (Randomized: 1 Brand, 3 Generic)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bupropion</title>
          <description>Subjects will be studied for 28 weeks in a sequential cross-over study:&#xD;
a 4-week lead-in phase during which all participants remain on their existing bupropion product&#xD;
Four randomized cross-over phases of 6 weeks on each of the four bupropion study drugs (brand Wellbutrin 300mg XL, Valeant, Par and Watson 3 generics)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" lower_limit="37" upper_limit="57"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion</title>
        <description>Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion</description>
        <time_frame>For 24 hours approximately every 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Valeant Brand Bupropion XL® 300mg</title>
            <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
          </group>
          <group group_id="O2">
            <title>Par Generic Bupropion XL® 300mg</title>
            <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
          </group>
          <group group_id="O3">
            <title>Watson Generic Bupropion XL® 300mg</title>
            <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
          </group>
          <group group_id="O4">
            <title>Mylan Generic Bupropion XL® 300mg</title>
            <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion</title>
          <description>Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion</description>
          <units>percentage of Brand</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bupropion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".84" lower_limit=".71" upper_limit="1.04"/>
                    <measurement group_id="O2" value=".88" lower_limit=".72" upper_limit="1.08"/>
                    <measurement group_id="O3" value=".83" lower_limit=".68" upper_limit=".99"/>
                    <measurement group_id="O4" value=".89" lower_limit=".7" upper_limit="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydroxybupropion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="15.5" upper_limit="25.5"/>
                    <measurement group_id="O2" value="20.9" lower_limit="15.9" upper_limit="28.1"/>
                    <measurement group_id="O3" value="21.8" lower_limit="15.9" upper_limit="26.5"/>
                    <measurement group_id="O4" value="21.6" lower_limit="15.9" upper_limit="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erthrohydrobuprion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.09" lower_limit="1.52" upper_limit="2.59"/>
                    <measurement group_id="O2" value="2.05" lower_limit="1.47" upper_limit="2.57"/>
                    <measurement group_id="O3" value="1.98" lower_limit="1.48" upper_limit="2.34"/>
                    <measurement group_id="O4" value="2.02" lower_limit="1.61" upper_limit="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Threohydrobupropion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.38" lower_limit="7.21" upper_limit="13.27"/>
                    <measurement group_id="O2" value="9.05" lower_limit="7.21" upper_limit="13.27"/>
                    <measurement group_id="O3" value="8.57" lower_limit="6.83" upper_limit="11.57"/>
                    <measurement group_id="O4" value="8.78" lower_limit="7.25" upper_limit="12.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Valeant Brand Bupropion XL® 300mg</title>
          <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
        </group>
        <group group_id="E2">
          <title>PAR Generic Bupropion XL® 300mg</title>
          <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
        </group>
        <group group_id="E3">
          <title>Watson Generic Bupropion XL® 300mg</title>
          <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</description>
        </group>
        <group group_id="E4">
          <title>Mylan Generic Bupropion XL® 300mg</title>
          <description>Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).</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="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="71"/>
              </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>Evan Kharasch MD PhD</name_or_title>
      <organization>Washington University</organization>
      <phone>3143628796</phone>
      <email>kharasch@wustl.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/NCT02209597
org study id: 201312021
nct id: NCT02209597
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Determine bioequivalence between branded and generic bupropion extended release (XL) products
      (and between generic products) at steady state in patients with major depressive disorder.
The protocol is a prospective, randomized, double-blinded, crossover study with Major
      Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).

      Subjects will be studied in 4 phases for a total of approximately 28 weeks:

      Phase 1: an approximately 4-week lead-in phase during which participants remain on their
      existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6
      weeks on each of the four bupropion study drugs (brand and 3 generics).
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Each participant receives the 4 drugs in sequence (sequence is randomized).
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: The randomization table will be generated by the Barnes-Jewish Hospital Investigational Pharmacy. Each subject will be assigned the next available number. Subjects, investigators, and all study team members will be blinded to drug treatment. In the case of dropouts (either subject- or investigator-initiated), subjects will be replaced, to provide the required number of subjects.
measure: Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
time frame: For 24 hours approximately every 6 weeks
description: Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion
arm group label: StudyArm
arm group type: Experimental
description: Subjects will be studied for 28 weeks in a sequential cross-over study: a
Subjects will be studied in 4 phases for a total of approximately 28 weeks:
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
intervention type: Drug
intervention name: Bupropion XL 300
description: Subjects will be studied in 4 phases for a total of approximately 28 weeks:
Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).
arm group label: StudyArm
other name: Wellbutrin
other name: Par
other name: Mylan
other name: Valeant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Evan D Kharasch, MD, PhD
role: Principal Investigator
affiliation: Washington Univesity School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Bupropion
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 