<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/NCT01731119</url>
  </required_header>
  <id_info>
    <org_study_id>12-2302</org_study_id>
    <nct_id>NCT01731119</nct_id>
  </id_info>
  <brief_title>Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents</brief_title>
  <official_title>An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Foundation of Hope, North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching purpose of this pilot study is to collect preliminary data regarding the&#xD;
      variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic&#xD;
      naive children and adolescents in order to inform decisions about including a lurasidone arm&#xD;
      in a future large scale trial of different approaches to minimize antipsychotic associated&#xD;
      weight gain in the pediatric population. In adults, lurasidone appears to cause minimal&#xD;
      weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum,&#xD;
      or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic&#xD;
      exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes&#xD;
      associated with lurasidone treatment. Antipsychotic (AP) naive subjects will start open-label&#xD;
      treatment by following a flexible titration schedule. Quasi-antipsychotic naive subjects&#xD;
      (less than 4 weeks of total AP treatment) will be started on lurasidone and tapered off the&#xD;
      other antipsychotic over an estimated 4 weeks depending on the dose and tolerability of the&#xD;
      prior antipsychotic. Other psychoactive medications including antidepressants,&#xD;
      benzodiazepines, stimulants, alpha-2 agonists, and mood stabilizers are allowed as long as&#xD;
      the dose is not changed, unless it is clinically necessary. Assessments of weight, efficacy,&#xD;
      and side effects are conducted at baseline, week 2, week 4, week 8, and week 12. The primary&#xD;
      outcome is percent change in weight. The secondary outcomes include psychiatric efficacy&#xD;
      measures and side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Completing Treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Efficacy Measures</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Side Effects</measure>
    <time_frame>Baseline to12 weeks</time_frame>
    <description>Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Clinical Improvement</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <condition>Schizophreniform Disorder</condition>
  <condition>Psychosis NOS</condition>
  <condition>Autistic Disorder</condition>
  <condition>Asperger Syndrome</condition>
  <condition>Child Development Disorders, Pervasive</condition>
  <condition>Bipolar I Disorder</condition>
  <condition>Bipolar II Disorder</condition>
  <condition>Mood Disorder NOS</condition>
  <condition>Severe Major Depression With Psychotic Features</condition>
  <condition>Single Episode Major Depression Without Psychotic Symptoms</condition>
  <condition>Severe Mood Disorder With Psychotic Features</condition>
  <arm_group>
    <arm_group_label>Flexible Dose Latuda©</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latuda©</intervention_name>
    <description>All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
    <arm_group_label>Flexible Dose Latuda©</arm_group_label>
    <other_name>Lurasidone Hydrochloride tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female children and adolescents between 6 and 19 years of age of any race or&#xD;
             ethnicity&#xD;
&#xD;
          -  Subject must meet Diagnostic Statistical Manual (DSM)-IV-Text Revision (TR) criteria&#xD;
             for a psychotic spectrum, mood spectrum or autism spectrum disorder as defined by one&#xD;
             of the following diagnoses:&#xD;
&#xD;
               -  schizophrenia (any type)&#xD;
&#xD;
               -  schizoaffective disorder&#xD;
&#xD;
               -  schizophreniform disorder&#xD;
&#xD;
               -  psychosis Not Otherwise Specified (NOS)&#xD;
&#xD;
               -  autistic disorder with significant irritability/aggression (Aberrant Behavioral&#xD;
                  Checklist-Community (ABC-C) Irritability subscale score of greater than or equal&#xD;
                  to 18)&#xD;
&#xD;
               -  Asperger syndrome with significant irritability/aggression (ABC-C Irritability&#xD;
                  subscale score of greater than or equal to 18)&#xD;
&#xD;
               -  pervasive developmental disorder NOS with significant irritability/aggression&#xD;
                  (ABC-C Irritability subscale score of greater than or equal to 18)&#xD;
&#xD;
               -  bipolar type I&#xD;
&#xD;
               -  bipolar type II&#xD;
&#xD;
               -  mood disorder NOS&#xD;
&#xD;
               -  major depression with psychotic features&#xD;
&#xD;
               -  major depression (unresponsive to 2 different antidepressants)&#xD;
&#xD;
               -  severe mood dysregulation (SMD) according to Leibenluft and colleagues broad&#xD;
                  spectrum bipolar disorder&#xD;
&#xD;
          -  Subjects must have ≤ 4 weeks of lifetime exposure to an antipsychotic medication at&#xD;
             any dosage. These medications include olanzapine (Zyprexa©), quetiapine (Seroquel©),&#xD;
             risperidone (Risperdal©), ziprasidone (Geodon©), aripiprazole (Abilify©), asenapine&#xD;
             (Saphris©), iloperidone (Fanapt©), lurasidone (Latuda©), haloperidol, chlorpromazine,&#xD;
             perphenazine, fluphenazine, thiothixene, or clozapine&#xD;
&#xD;
          -  Subjects on other psychoactive medications are asked not to change dose of those&#xD;
             medications during the course of the study unless clinically necessary&#xD;
&#xD;
          -  Sexually active girls must agree to use two effective forms of birth control (i.e.&#xD;
             hormonal or spermicidal and barrier) or be abstinent)&#xD;
&#xD;
          -  Primary caretaker is able to participate in study appointments as is clinically&#xD;
             indicated&#xD;
&#xD;
          -  Ability of child to participate in all aspects of the protocol per investigator's&#xD;
             clinical judgment&#xD;
&#xD;
          -  After considering all aspects of study participation the subject (if an adult) or&#xD;
             subject's parent or Legally Authorized Representative (LAR) must consent to&#xD;
             participation&#xD;
&#xD;
          -  After considering all aspects of study participation, the subject must assent to&#xD;
             participation if it is developmentally appropriate to obtain assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Based on current or lifetime DSM-IV-TR criteria, a diagnosis of Eating Disorder&#xD;
             (Anorexia Nervosa or Bulimia Nervosa)&#xD;
&#xD;
          -  Based on DSM-IV-TR criteria, a diagnosis of Substance Dependence Disorder (other than&#xD;
             tobacco dependence) within the past month&#xD;
&#xD;
          -  Treatment with the following concomitant medications: strong CYP3A4 inhibitors (ex:&#xD;
             Ketoconazole), strong CYP3A4 inducers (ex: Rifampin)&#xD;
&#xD;
          -  Current or past treatment with lurasidone (Latuda©) that resulted in a non-response or&#xD;
             intolerance&#xD;
&#xD;
          -  Females who are pregnant or breast-feeding&#xD;
&#xD;
          -  Ongoing or previously undisclosed child abuse requiring new department of social&#xD;
             service intervention&#xD;
&#xD;
          -  Subjects who, in the Investigator's opinion, might not be suitable for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linmarie Sikich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>February 23, 2017</results_first_submitted>
  <results_first_submitted_qc>April 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2017</results_first_posted>
  <last_update_submitted>May 18, 2017</last_update_submitted>
  <last_update_submitted_qc>May 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Latuda,lurasidone,antipsychotics,autism, mood, psychosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Asperger Syndrome</mesh_term>
    <mesh_term>Developmental Disabilities</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lurasidone Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Flexible Dose Latuda©</title>
          <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Flexible Dose Latuda©</title>
          <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </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="11.4" spread="3.2"/>
                  </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="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Weight</title>
        <description>Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Dose Latuda©</title>
            <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Weight</title>
          <description>Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.</description>
          <units>lbs</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" lower_limit="-5.29" upper_limit="6.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Completing Treatment</title>
        <description>Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Dose Latuda©</title>
            <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Completing Treatment</title>
          <description>Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Efficacy Measures</title>
        <description>Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Dose Latuda©</title>
            <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Efficacy Measures</title>
          <description>Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14" lower_limit="-42.76" upper_limit="14.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Side Effects</title>
        <description>Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.</description>
        <time_frame>Baseline to12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Dose Latuda©</title>
            <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Side Effects</title>
          <description>Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Clinical Improvement</title>
        <description>Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Dose Latuda©</title>
            <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Clinical Improvement</title>
          <description>Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Flexible Dose Latuda©</title>
          <description>Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.&#xD;
Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.</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="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="3" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Linmarie Sikich</name_or_title>
      <organization>UNC-Chapel Hill</organization>
      <email>linmarie_sikich@med.unc.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/NCT01731119
org study id: 12-2302
nct id: NCT01731119
lead sponsor: 
collaborator: 
has dmc: No
The overarching purpose of this pilot study is to collect preliminary data regarding the
      variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic
      naive children and adolescents in order to inform decisions about including a lurasidone arm
      in a future large scale trial of different approaches to minimize antipsychotic associated
      weight gain in the pediatric population. In adults, lurasidone appears to cause minimal
      weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum,
      or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic
      exposure.
This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes
      associated with lurasidone treatment. Antipsychotic (AP) naive subjects will start open-label
      treatment by following a flexible titration schedule. Quasi-antipsychotic naive subjects
      (less than 4 weeks of total AP treatment) will be started on lurasidone and tapered off the
      other antipsychotic over an estimated 4 weeks depending on the dose and tolerability of the
      prior antipsychotic. Other psychoactive medications including antidepressants,
      benzodiazepines, stimulants, alpha-2 agonists, and mood stabilizers are allowed as long as
      the dose is not changed, unless it is clinically necessary. Assessments of weight, efficacy,
      and side effects are conducted at baseline, week 2, week 4, week 8, and week 12. The primary
      outcome is percent change in weight. The secondary outcomes include psychiatric efficacy
      measures and side effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Weight
time frame: Baseline to 12 weeks
description: Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.
measure: Proportion of Participants Completing Treatment
time frame: 12 weeks
description: Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.
measure: Changes in Efficacy Measures
time frame: Baseline to 12 weeks
description: Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.
measure: Number of Participants Experiencing Side Effects
time frame: Baseline to12 weeks
description: Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.
measure: Overall Clinical Improvement
time frame: Baseline to 12 weeks
description: Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).
arm group label: Flexible Dose Latuda©
arm group type: Experimental
description: Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
intervention type: Drug
intervention name: Latuda©
description: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.
arm group label: Flexible Dose Latuda©
other name: Lurasidone Hydrochloride tablets
criteria: 
gender: All
minimum age: 6 Years
maximum age: 19 Years
healthy volunteers: No
last name: Linmarie Sikich, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Mental Disorders
mesh term: Depressive Disorder, Major
mesh term: Mood Disorders
mesh term: Autistic Disorder
mesh term: Asperger Syndrome
mesh term: Developmental Disabilities
mesh term: Child Development Disorders, Pervasive
mesh term: Lurasidone Hydrochloride
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 