<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/NCT01686815</url>
  </required_header>
  <id_info>
    <org_study_id>CILO522DUSXXT</org_study_id>
    <nct_id>NCT01686815</nct_id>
  </id_info>
  <brief_title>Cross-Sectional Iloperidone IVGTT</brief_title>
  <official_title>Cross-sectional Study to Compare Glucose and Lipid Metabolism in SMI Subjects Treated With Either Fanapt (Iloperidone), Zyprexa (Olanzapine), or Risperdal (Risperidone)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to utilize state of the art procedures such as the frequently sampled&#xD;
      intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein&#xD;
      analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the&#xD;
      metabolic abnormalities associated with other atypical antipsychotic treatments, namely&#xD;
      olanzapine and risperidone, and offers an advantage over these other agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This one-month research study examines how Fanapt® (iloperidone), Zyprexa® (olanzapine), or&#xD;
      Risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia,&#xD;
      schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS,&#xD;
      delusional disorder or paranoid disorder. This study requires 3 research visits and includes&#xD;
      a physical exam, medical history, vitals, an EKG, cognitive testing, psychological rating&#xD;
      scales, a DEXA scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test&#xD;
      (IVGTT) and a fasting blood draw.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between cohorts in glucose metabolism</measure>
    <time_frame>Baseline</time_frame>
    <description>Difference between olanzapine- or risperidone-treated subjects, and Iloperidone-treated subjects on glucose metabolism as measured by the FSIVGTT procedure at one time point (Baseline).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between cohorts in triglycerides</measure>
    <time_frame>Baseline</time_frame>
    <description>Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in triglyceride levels measured at one time point (Baseline).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between cohorts on LDL cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in LDL cholesterol levels measured at one time point (Baseline).</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Serious Mental Illness</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Insulin Resistance</condition>
  <condition>Glucose Metabolism</condition>
  <arm_group>
    <arm_group_label>Olanzapine</arm_group_label>
    <description>Olanzapine-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risperidone</arm_group_label>
    <description>Risperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iloperidone</arm_group_label>
    <description>Iloperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples will be retained to test IL-6 and other inflammatory markers.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will include 60 outpatients between the ages of 18-65 with schizophrenia,&#xD;
        schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS,&#xD;
        delusional disorder or paranoid disorder. 60 subjects will be screened and 45 will enter&#xD;
        the cross-sectional study (15 olanzapine, 15 iloperidone, 15 risperidone-treated subjects&#xD;
        matched for BMI).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male/Female ages 18-65 years&#xD;
&#xD;
          2. Capacity to provide informed consent&#xD;
&#xD;
          3. BMI between 20 and 30 kg/m²&#xD;
&#xD;
          4. Diagnosis of a serious mental illness, including schizophrenia, any subtype;&#xD;
             schizoaffective disorder, any subtype; major depressive disorder, bipolar disorder,&#xD;
             psychosis NOS, delusional disorder and paranoid disorder&#xD;
&#xD;
          5. Treatment with iloperidone, risperidone, or olanzapine for at least 6 months&#xD;
&#xD;
          6. Stable dose of antipsychotic agent for at least one month&#xD;
&#xD;
          7. Well established compliance with out-patient medications and clinically stable&#xD;
&#xD;
          8. Female subjects will be eligible to participate in the study if they are of&#xD;
             non-childbearing potential or of child-bearing potential and willing to practice&#xD;
             appropriate birth control methods (complete abstinence from sexual intercourse, female&#xD;
             sterilization, sterilization of male partner, implants of levonorgestrel, injectable&#xD;
             progestogen, oral contraceptives, intrauterine devices, or double barrier methods of&#xD;
             contraception using spermicide with either a condom or diaphragm) during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to provide informed consent&#xD;
&#xD;
          2. Current substance abuse&#xD;
&#xD;
          3. Psychiatrically unstable and/or hospitalized in the past month&#xD;
&#xD;
          4. History of significant and untreated medical illness including severe cardiovascular,&#xD;
             hepatic, renal, or untreated thyroid disease; hepatitis; or HIV&#xD;
&#xD;
          5. Current insulin treatment for diabetes&#xD;
&#xD;
          6. Currently taking the following medications: birth control pills containing norgestrol,&#xD;
             steroids, thiazide diuretics, or treatment with agents that induce weight loss&#xD;
&#xD;
          7. Intentions of donating blood during or within 30 days of completion of the study.&#xD;
&#xD;
          8. Use of valproate or carbamazepine within four weeks of the study&#xD;
&#xD;
          9. History of immunosuppression&#xD;
&#xD;
         10. Current or recent radiation or chemotherapy treatment for cancer&#xD;
&#xD;
         11. Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maurizio Fava, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Maurizio Fava, MD</investigator_full_name>
    <investigator_title>Vice Chair, Psychiatry</investigator_title>
  </responsible_party>
  <keyword>metabolic side effects</keyword>
  <keyword>atypical antipsychotics</keyword>
  <keyword>FSIVGTT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01686815
org study id: CILO522DUSXXT
nct id: NCT01686815
lead sponsor: 
collaborator: 
has dmc: No
This study aims to utilize state of the art procedures such as the frequently sampled
      intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein
      analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the
      metabolic abnormalities associated with other atypical antipsychotic treatments, namely
      olanzapine and risperidone, and offers an advantage over these other agents.
This one-month research study examines how Fanapt® (iloperidone), Zyprexa® (olanzapine), or
      Risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia,
      schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS,
      delusional disorder or paranoid disorder. This study requires 3 research visits and includes
      a physical exam, medical history, vitals, an EKG, cognitive testing, psychological rating
      scales, a DEXA scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test
      (IVGTT) and a fasting blood draw.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Difference between cohorts in glucose metabolism
time frame: Baseline
description: Difference between olanzapine- or risperidone-treated subjects, and Iloperidone-treated subjects on glucose metabolism as measured by the FSIVGTT procedure at one time point (Baseline).
measure: Difference between cohorts in triglycerides
time frame: Baseline
description: Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in triglyceride levels measured at one time point (Baseline).
measure: Difference between cohorts on LDL cholesterol
time frame: Baseline
description: Difference between olanzapine- or risperidone-subjects and subjects treated with iloperidone in LDL cholesterol levels measured at one time point (Baseline).
arm group label: Olanzapine
description: Olanzapine-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder.
arm group label: Risperidone
description: Risperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder.
arm group label: Iloperidone
description: Iloperidone-treated patients with serious mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS, delusional disorder or paranoid disorder.
Samples will be retained to test IL-6 and other inflammatory markers.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Maurizio Fava, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Maurizio Fava, MD
investigator title: Vice Chair, Psychiatry
mesh term: Metabolic Syndrome
mesh term: Insulin Resistance
mesh term: Schizophrenia
mesh term: Mental Disorders