<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/NCT01717040</url>
  </required_header>
  <id_info>
    <org_study_id>Kemp DBDAT</org_study_id>
    <nct_id>NCT01717040</nct_id>
  </id_info>
  <brief_title>Pioglitazone for the Treatment of Bipolar Depression</brief_title>
  <official_title>Double-Blind, Placebo-Controlled Trial of Pioglitazone for Bipolar Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Depressive and Bipolar Disorder Alternative Treatment Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to test the hypothesis that adjunctive pioglitazone is more&#xD;
      effective than placebo for the relief of acute depressive symptoms resulting from bipolar&#xD;
      disorder. The secondary objectives are to determine potential moderators and mediators of&#xD;
      antidepressant efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a double-blind, placebo-controlled 8-week trial of pioglitazone, either as&#xD;
      monotherapy or adjunctive to a mood stabilizer, for the acute relief of bipolar depression.&#xD;
      The enrollment goal is 80 subjects (40 patients each in the pioglitazone treatment group and&#xD;
      the placebo treatment group).&#xD;
&#xD;
      Screening Phase: Patients who have been prescribed a mood stabilizer for &gt; 4 weeks and are on&#xD;
      a therapeutic dose will proceed directly to the Screening Visit. For situations in which the&#xD;
      patient prefers to be taking a mood stabilizer or where the treating psychiatrist feels it is&#xD;
      clinically necessary, a mood stabilizer (lithium, divalproex, carbamazepine, lamotrigine,&#xD;
      olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone or lurasidone) will be&#xD;
      initiated (see Mood Stabilizer Initiation section below). For this set of patients who do&#xD;
      begin a mood stabilizer, the Screening Phase may last up to 8 weeks. Otherwise, subjects who&#xD;
      do not come in on a mood stabilizer will proceed directly to screening.&#xD;
&#xD;
      Double-Blind, Placebo-Controlled Study Period (Week 1 to Week 8): Patients who meet&#xD;
      inclusion/exclusion criteria will be randomized to study treatment at the&#xD;
      baseline/randomization visit within 30 days of the screening visit. The efficacy and safety&#xD;
      assessments will be carried out at baseline/randomization and then weekly or every two weeks&#xD;
      for a total of 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study ended early due to budgetary issues&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Pioglitazone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pioglitazone</intervention_name>
    <description>Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
    <arm_group_label>Pioglitazone</arm_group_label>
    <other_name>Actos</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Sugar Pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be male or female &gt;= 18 years of age&#xD;
&#xD;
          -  Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder (type I,&#xD;
             II, or NOS)&#xD;
&#xD;
          -  Currently depressed as confirmed by the Mini-International Neuropsychiatric Interview&#xD;
             (M.I.N.I.)-Plus at the screening visit&#xD;
&#xD;
          -  Inventory of Depressive Symptoms total score &gt; 25 or Quick Inventory of Depressive&#xD;
             Symptomatology-Self-Report (QIDS-SR16) &gt; 11 at study baseline&#xD;
&#xD;
          -  Women of childbearing potential (not surgically sterile or 2 years postmenopausal),&#xD;
             must use a medically accepted method of contraception and must agree to continue use&#xD;
             of this method for the duration of the study and for 30 days after participation in&#xD;
             the study. Acceptable methods of contraception include barrier method with spermicide,&#xD;
             abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal,&#xD;
             implanted, and injected) in conjunction with a barrier method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Unstable or inadequately treated medical illness as judged by the investigator&#xD;
&#xD;
          -  Severe personality disorder&#xD;
&#xD;
          -  Serious suicidal risk as judged by the investigator or having a score ≥ 4 on&#xD;
             Montgomery Asberg Depression Rating Scale (MADRS) item number 10 (suicidal thoughts)&#xD;
             at screening or baseline&#xD;
&#xD;
          -  Known history of intolerance or hypersensitivity to pioglitazone&#xD;
&#xD;
          -  Treatment with pioglitazone in the 3 months prior to randomization&#xD;
&#xD;
          -  Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study&#xD;
             entry&#xD;
&#xD;
          -  Currently taking insulin or rosiglitazone.&#xD;
&#xD;
          -  Diagnosed with dementia&#xD;
&#xD;
          -  Acute Mania as defined by a Young Mania Rating Scale (YMRS) score &gt; 15&#xD;
&#xD;
          -  Diagnosed with heart failure&#xD;
&#xD;
          -  Transaminase elevation &gt;2.5 times the upper limit of normal&#xD;
&#xD;
          -  Presence of renal impairment (eg. creatinine &gt; 1.5)&#xD;
&#xD;
          -  History of bladder carcinoma&#xD;
&#xD;
          -  Fasting blood glucose &gt;150 mg/dL and Hb A1c&gt; 7%; participants meeting these criteria&#xD;
             will be referred to an endocrinologist or their primary care physician for a diabetes&#xD;
             evaluation and education.&#xD;
&#xD;
          -  Receiving acute series of electroconvulsive therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Kemp, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center - Mood Disorders Program</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cwrupsychiatry.org/research/mood-disorders</url>
    <description>Mood Disorders Program at University Hospitals Cleveland Medical Center</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>September 19, 2016</results_first_submitted>
  <results_first_submitted_qc>November 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 27, 2017</results_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Joseph Calabrese, MD</investigator_full_name>
    <investigator_title>Director, Mood Disorders Program</investigator_title>
  </responsible_party>
  <keyword>Bipolar Disorder</keyword>
  <keyword>Insulin Resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pioglitazone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pioglitazone</title>
          <description>Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Required Medication Change</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>New Substance Use Disorder</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pioglitazone</title>
          <description>Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</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="17"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.71" spread="12.071"/>
                    <measurement group_id="B2" value="43.65" spread="12.979"/>
                    <measurement group_id="B3" value="45.05" spread="12.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </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="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </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>
          <title>Bipolar Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>BP 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BP 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BP NOS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score</title>
        <description>Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms</description>
        <time_frame>Baseline and Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pioglitazone</title>
            <description>Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score</title>
          <description>Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" spread="3.0"/>
                    <measurement group_id="O2" value="24.3" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Pioglitazone</title>
          <description>Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="6" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Shortness of Breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Stomach Upset</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomitting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hot Flashes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hair Loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Increased Thirst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Increased Urinary Frequency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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>Carla Conroy, MPH</name_or_title>
      <organization>Univeristy Hospitals Cleveland Medical Center</organization>
      <phone>216-844-2871</phone>
      <email>carla.conroy@UHhospitals.org</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/NCT01717040
org study id: Kemp DBDAT
nct id: NCT01717040
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective is to test the hypothesis that adjunctive pioglitazone is more
      effective than placebo for the relief of acute depressive symptoms resulting from bipolar
      disorder. The secondary objectives are to determine potential moderators and mediators of
      antidepressant efficacy.
The study is a double-blind, placebo-controlled 8-week trial of pioglitazone, either as
      monotherapy or adjunctive to a mood stabilizer, for the acute relief of bipolar depression.
      The enrollment goal is 80 subjects (40 patients each in the pioglitazone treatment group and
      the placebo treatment group).

      Screening Phase: Patients who have been prescribed a mood stabilizer for > 4 weeks and are on
      a therapeutic dose will proceed directly to the Screening Visit. For situations in which the
      patient prefers to be taking a mood stabilizer or where the treating psychiatrist feels it is
      clinically necessary, a mood stabilizer (lithium, divalproex, carbamazepine, lamotrigine,
      olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone or lurasidone) will be
      initiated (see Mood Stabilizer Initiation section below). For this set of patients who do
      begin a mood stabilizer, the Screening Phase may last up to 8 weeks. Otherwise, subjects who
      do not come in on a mood stabilizer will proceed directly to screening.

      Double-Blind, Placebo-Controlled Study Period (Week 1 to Week 8): Patients who meet
      inclusion/exclusion criteria will be randomized to study treatment at the
      baseline/randomization visit within 30 days of the screening visit. The efficacy and safety
      assessments will be carried out at baseline/randomization and then weekly or every two weeks
      for a total of 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
time frame: Baseline and Week 8
description: Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms
arm group label: Pioglitazone
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pioglitazone
description: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
arm group label: Pioglitazone
other name: Actos
intervention type: Drug
intervention name: Placebo
description: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
arm group label: Placebo
other name: Sugar Pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Kemp, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
url: http://www.cwrupsychiatry.org/research/mood-disorders
description: Mood Disorders Program at University Hospitals Cleveland Medical Center
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Joseph Calabrese, MD
investigator title: Director, Mood Disorders Program
mesh term: Insulin Resistance
mesh term: Bipolar Disorder
mesh term: Pioglitazone
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 