<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/NCT02219009</url>
  </required_header>
  <id_info>
    <org_study_id>316-14-220</org_study_id>
    <nct_id>NCT02219009</nct_id>
  </id_info>
  <brief_title>Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole</brief_title>
  <official_title>A Multicenter, 8-week, Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adult Subjects With Schizophrenia Who Are Treated With Oral Aripiprazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the usability of the Medical Information Device #1&#xD;
      (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor adherence to medication is a well-recognized problem in psychiatric patients. Although a&#xD;
      variety of treatment models have been developed to improve management of patients in general&#xD;
      and medication adherence in particular, poor medication adherence remains a major barrier to&#xD;
      achieving optimal health.&#xD;
&#xD;
      The MIND1 System includes a drug-device combination, a patch, and application software to&#xD;
      convey level of activity and rest and to mark events through the act of ingestion.&#xD;
&#xD;
      The purpose of this open-label study is to determine the usability of the Medical Information&#xD;
      Device #1 (MIND1) System in adults with schizophrenia. Approximately 32 subjects with&#xD;
      schizophrenia, between 18 and 65 years of age (inclusive) who are currently prescribed and&#xD;
      stabilized on oral aripiprazole, will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Proportion of Participants Who Are Able to Pair &amp; Apply a Patch Independently &amp; Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Able to Pair &amp; Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Time During the Study Period When Participants Wear Their Patches</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Mental Disorder</condition>
  <condition>Nervous System Diseases</condition>
  <arm_group>
    <arm_group_label>MIND1 System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MIND1 System</intervention_name>
    <description>Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.</description>
    <arm_group_label>MIND1 System</arm_group_label>
    <other_name>OPC-14597 Digital</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be prepared and able to give written (signed and dated) informed&#xD;
             consent, which includes adherence to study requirements and restrictions before&#xD;
             enrolling in the study. Subjects must be willing to adhere to study procedures,&#xD;
             including troubleshooting of the MIND1 System by a third party if needed (third party&#xD;
             will be blinded to personal health information).&#xD;
&#xD;
          -  Male and female subjects 18 to 65 years of age, inclusive, at time of informed&#xD;
             consent.&#xD;
&#xD;
          -  Subjects who have a primary current diagnosis of schizophrenia, as defined by&#xD;
             Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.&#xD;
             Subjects may be symptomatic at screening, but must be able to be treated as&#xD;
             outpatients.&#xD;
&#xD;
          -  Subject is cooperative, able to ingest oral medication, and willing to complete all&#xD;
             aspects of study.&#xD;
&#xD;
          -  Subject is currently prescribed oral aripiprazole for schizophrenia at one of the&#xD;
             following single daily doses (10, 15, 20, or 30 mg), and is deemed likely to remain on&#xD;
             this same stable dose throughout the course of the study. Subject has not had any&#xD;
             changes in their aripiprazole regimen or dose over the 2 weeks before screening.&#xD;
&#xD;
          -  Subject must be able and willing to carry the MIND1 System smartphone on his/her&#xD;
             person and complete all tasks, as well as adequately operate all devices, as&#xD;
             applicable. Caregiver or other third-party assistance can be utilized, if needed,&#xD;
             although all subjects should be encouraged to attempt all tasks themselves.&#xD;
&#xD;
          -  Subject likely possesses the capacity to utilize the technology interfaces (eg, open&#xD;
             and navigate software applications using the touch screen) and telephone features of a&#xD;
             smartphone. The subject has satisfactory mobile phone reception (preferably 3 bars or&#xD;
             more, or have Wi-Fi) at home and/or at work for study-designated wireless carrier.&#xD;
&#xD;
          -  Subject is not pregnant or breast-feeding, and does not plan to become pregnant.&#xD;
&#xD;
          -  Skin on the anterior chest just above the lower edge of the rib cage that is free of&#xD;
             any dermatological problems (eg, dermatosis or dermatitis, open wounds, or other skin&#xD;
             disorders such as warts, rashes, atopic dermatitis, or irritations).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a current DSM-5 diagnosis other than schizophrenia, including major&#xD;
             depressive disorder, bipolar disorder, schizoaffective disorder, delirium, major&#xD;
             neurocognitive disorder (eg, dementia), intellectual developmental disorder, or any&#xD;
             other diagnosis that might impact the subject's ability to participate in the study.&#xD;
             Other disorders that are not the focus of treatment and will not impact the subject's&#xD;
             ability to participate in all aspects of the study (eg, social anxiety disorder) may&#xD;
             be included.&#xD;
&#xD;
          -  Subjects with a current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid,&#xD;
             schizotypal, or histrionic personality disorder.&#xD;
&#xD;
          -  Subjects who exhibit prominent negative symptoms that, in the judgment of the&#xD;
             investigator, will interfere with study procedures or unable to adhere with study&#xD;
             requirements.&#xD;
&#xD;
          -  Subjects who are currently on a long-acting injectable antipsychotic.&#xD;
&#xD;
          -  Subjects who are likely to be incapable of using the MIND1 System technology, even&#xD;
             with assistance.&#xD;
&#xD;
          -  On the Columbia-Suicide Severity Rating Scale (C-SSRS) Subjects who answer &quot;Yes&quot; to&#xD;
             Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without&#xD;
             Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4&#xD;
             occurred within the last 3 months, OR Subjects who answer &quot;Yes&quot; on the C-SSRS Suicidal&#xD;
             Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose&#xD;
             most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 3&#xD;
             months, OR Subjects who answer &quot;Yes&quot; on any of the 5 C-SSRS Suicidal Behavior Items&#xD;
             (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior)&#xD;
             and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal&#xD;
             Behavior Items occurred within the last 1 year, OR Subjects who, in the opinion of the&#xD;
             investigator, present a serious risk of suicide.&#xD;
&#xD;
          -  Subject has received any investigational product within the last 30 days, including&#xD;
             the MIND1 System (eg, subjects who participated in Cohort 1 of this study are not&#xD;
             eligible for Cohort 2).&#xD;
&#xD;
          -  Subjects who have a history or evidence of a medical condition that would expose them&#xD;
             to an undue risk of a significant AE or interfere with assessments of safety or&#xD;
             usability during the course of the study, including but not limited to, hepatic,&#xD;
             renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic&#xD;
             disease, as determined by the clinical judgment of the investigator.&#xD;
&#xD;
          -  Subjects with epilepsy or a history of seizures (except for a single childhood febrile&#xD;
             seizure, post traumatic seizure, alcohol withdrawal seizure, etc).&#xD;
&#xD;
          -  Subjects with a history of neuroleptic malignant syndrome or clinically significant&#xD;
             tardive dyskinesia, as assessed by the investigator.&#xD;
&#xD;
          -  Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment&#xD;
             with aripiprazole or other quinolinones.&#xD;
&#xD;
          -  Subjects with a history of hypersensitivity to antipsychotic agents.&#xD;
&#xD;
          -  Subjects with a known allergy to adhesive tape or any pertinent components of the&#xD;
             patch or IEM&#xD;
&#xD;
          -  Sexually active women of childbearing potential who will not commit to utilizing 2 of&#xD;
             the approved birth control methods or who will not remain abstinent during this study&#xD;
             and for 30 days following the last dose of study medication.&#xD;
&#xD;
          -  Sexually active males (unless sterile, defined as having had a bilateral orchiectomy)&#xD;
             who will not commit to utilizing 2 of the approved birth control methods or who will&#xD;
             not remain abstinent during the study and for 90 days following the last dose of study&#xD;
             drug.&#xD;
&#xD;
          -  Subject has a current history (within the past month) of a substance use disorder&#xD;
             (excluding tobacco) which meets DSM-5 criteria, or demonstrates a positive result on&#xD;
             the urine drug test during screening. Subjects with a positive drug screen for drugs&#xD;
             of abuse (excluding cannabinoids) are excluded and may not be retested or rescreened.&#xD;
             Subjects with a positive urine drug screen resulting from use of prescription (such as&#xD;
             opioids) or over-the-counter medications or products that, in the investigator's&#xD;
             documented opinion, do not signal a clinical condition that would impact the safety of&#xD;
             the subject or interpretation of the study results may continue evaluation for the&#xD;
             study following consultation and approval by the Medical Monitor.&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, are acutely psychotic or who exhibit&#xD;
             symptoms currently requiring hospitalization.&#xD;
&#xD;
          -  Subjects unwilling to refrain from the use of topical products on the skin patch&#xD;
             sites.&#xD;
&#xD;
          -  Subjects unwilling or unable to complete the evaluations included in this study, which&#xD;
             include audio recording of the subject's voice and require the ability to distinguish&#xD;
             colors (eg, subjects unwilling to be recorded and colorblind subjects are to be&#xD;
             excluded from participation in this study)&#xD;
&#xD;
          -  Any subject who, in the opinion of the investigator, should not participate in the&#xD;
             study.&#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>Timothy Peters-Strickland, MD</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>July 16, 2018</results_first_submitted>
  <results_first_submitted_qc>July 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2018</results_first_posted>
  <disposition_first_submitted>May 11, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>May 11, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 2, 2016</disposition_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OPC-14597 Digital</keyword>
  <keyword>Aripiprazole</keyword>
  <keyword>Medical Information Device #1 System (MIND1)</keyword>
  <keyword>Treatment Adherence</keyword>
  <keyword>Ingestible Event Marker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aripiprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted in 67 participants at 6 trial sites in the United States.</recruitment_details>
      <pre_assignment_details>The trial included a screening period (≤ 2 weeks), a treatment period (8 weeks), and a safety follow-up period (2 weeks). Participants enrolled under the original version of the protocol were considered to comprise a first cohort (Cohort 1), while subjects enrolled under Amendment 1 were considered to comprise a separate second cohort (Cohort 2).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MIND1 System (Cohort 1)</title>
          <description>Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).&#xD;
Cohort 1 participants were enrolled under the original protocol.</description>
        </group>
        <group group_id="P2">
          <title>MIND 1 System (Cohort 2)</title>
          <description>Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.&#xD;
Cohort 2 participants were enrolled under protocol amendment 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <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="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled sample - all participants who signed an informed consent and entered the trial.</population>
      <group_list>
        <group group_id="B1">
          <title>MIND1 System (Cohort 1)</title>
          <description>Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).&#xD;
Cohort 1 participants were enrolled under the original protocol.</description>
        </group>
        <group group_id="B2">
          <title>MIND 1 System (Cohort 2)</title>
          <description>Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.&#xD;
Cohort 2 participants were enrolled under protocol amendment 1.</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="37"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="67"/>
          </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="45.8" spread="10.3"/>
                    <measurement group_id="B2" value="47.6" spread="8.9"/>
                    <measurement group_id="B3" value="46.6" spread="9.7"/>
                  </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="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Who Are Able to Pair &amp; Apply a Patch Independently &amp; Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)</title>
        <description>Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The intent-to-treat (ITT) population - all participants who entered the trial and used the MIND1 system</population>
        <group_list>
          <group group_id="O1">
            <title>MIND1 System (Cohort 1)</title>
            <description>Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).&#xD;
Cohort 1 participants were enrolled under the original protocol.</description>
          </group>
          <group group_id="O2">
            <title>MIND 1 System (Cohort 2)</title>
            <description>Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.&#xD;
Cohort 2 participants were enrolled under protocol amendment 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Who Are Able to Pair &amp; Apply a Patch Independently &amp; Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)</title>
          <description>Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.</description>
          <population>The intent-to-treat (ITT) population - all participants who entered the trial and used the MIND1 system</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.1" lower_limit="36.9" upper_limit="70.5"/>
                    <measurement group_id="O2" value="56.7" lower_limit="37.4" upper_limit="74.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Able to Pair &amp; Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.</title>
        <description>Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>ITT population - all participants who entered the trial and used the MIND1 system.</population>
        <group_list>
          <group group_id="O1">
            <title>MIND1 System (Cohort 1)</title>
            <description>Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).&#xD;
Cohort 1 participants were enrolled under the original protocol.</description>
          </group>
          <group group_id="O2">
            <title>MIND 1 System (Cohort 2)</title>
            <description>Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.&#xD;
Cohort 2 participants were enrolled under protocol amendment 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Able to Pair &amp; Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.</title>
          <description>Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.</description>
          <population>ITT population - all participants who entered the trial and used the MIND1 system.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8" lower_limit="68.0" upper_limit="93.8"/>
                    <measurement group_id="O2" value="80.0" lower_limit="61.4" upper_limit="92.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Time During the Study Period When Participants Wear Their Patches</title>
        <description>Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>ITT population - all participants who entered the trial and used the MIND1 system.</population>
        <group_list>
          <group group_id="O1">
            <title>MIND1 System (Cohort 1)</title>
            <description>Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).&#xD;
Cohort 1 participants were enrolled under the original protocol.</description>
          </group>
          <group group_id="O2">
            <title>MIND 1 System (Cohort 2)</title>
            <description>Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.&#xD;
Cohort 2 participants were enrolled under protocol amendment 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Time During the Study Period When Participants Wear Their Patches</title>
          <description>Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.</description>
          <population>ITT population - all participants who entered the trial and used the MIND1 system.</population>
          <units>% of time participants wore patch</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" spread="22.0"/>
                    <measurement group_id="O2" value="66.2" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of signing the informed consent, throughout the 8 week treatment period and for 2 weeks after the last treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MIND1 System (Cohort 1)</title>
          <description>Participants received aripiprazole tablets embedded with an ingestible event marker (IEM). They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a Medical Data Device System (MDDS).&#xD;
Cohort 1 participants were enrolled under the original protocol.</description>
        </group>
        <group group_id="E2">
          <title>MIND 1 System (Cohort 2)</title>
          <description>Participants received aripiprazole tablets embedded with an IEM. They discontinued their normally prescribed oral aripiprazole tablets and took aripiprazole + IEM tablets (eg, at the previously prescribed dose) during an 8-week treatment period. Aripiprazole + IEM tablets were taken on a once-daily dosing schedule. Participants wore a patch which received signals from the IEM and transmitted information to a MDDS.&#xD;
Cohort 2 participants were enrolled under protocol amendment 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</default_vocab>
        <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="17" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased appetitie</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Center may publish study results but ≥ 60 days prior to any public presentation, a copy is sent to Sponsor for review and Center can delay publication for 60 days to permit Sponsor to protect its intellectual property rights or confidential information contained within the publication. The first publication is a joint publication, if Center is part of a multi-center study. Center is free to publish, if there is no multi-center publication within 18 months of completion/ termination of study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Affairs</name_or_title>
      <organization>Otsuka Pharmaceutical Development and Commercialization, Inc.</organization>
      <phone>800 562-3974</phone>
    </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/NCT02219009
org study id: 316-14-220
nct id: NCT02219009
lead sponsor: 
The purpose of this study is to determine the usability of the Medical Information Device #1
      (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
Poor adherence to medication is a well-recognized problem in psychiatric patients. Although a
      variety of treatment models have been developed to improve management of patients in general
      and medication adherence in particular, poor medication adherence remains a major barrier to
      achieving optimal health.

      The MIND1 System includes a drug-device combination, a patch, and application software to
      convey level of activity and rest and to mark events through the act of ingestion.

      The purpose of this open-label study is to determine the usability of the Medical Information
      Device #1 (MIND1) System in adults with schizophrenia. Approximately 32 subjects with
      schizophrenia, between 18 and 65 years of age (inclusive) who are currently prescribed and
      stabilized on oral aripiprazole, will be enrolled.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)
time frame: Baseline to Week 8
description: Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.
measure: Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.
time frame: Baseline to Week 8
description: Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.
measure: Proportion of Time During the Study Period When Participants Wear Their Patches
time frame: Baseline to Week 8
description: Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.
arm group label: MIND1 System
arm group type: Experimental
intervention type: Device
intervention name: MIND1 System
description: Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
arm group label: MIND1 System
other name: OPC-14597 Digital
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Timothy Peters-Strickland, MD
role: Study Director
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nervous System Diseases
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Aripiprazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 