<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/NCT03005769</url>
  </required_header>
  <id_info>
    <org_study_id>031-306-00108</org_study_id>
    <nct_id>NCT03005769</nct_id>
  </id_info>
  <brief_title>Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy</brief_title>
  <acronym>DOMINO</acronym>
  <official_title>Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Europe Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Europe Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational, retrospective, non-interventional study that will include&#xD;
      schizophrenic patients who were initiated with aripiprazole once-monthly as per normal&#xD;
      clinical practice at least 6 months before the data collection starts (inclusion visit), and&#xD;
      is designed to evaluate demographic and clinical predictors of persistence with this&#xD;
      treatment.&#xD;
&#xD;
      Data from each patient will be collected after informed consent is signed (inclusion visit),&#xD;
      and will include retrospective information from the start of aripiprazole once-monthly&#xD;
      treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months&#xD;
      after the index date). Data will be retrospectively collected from all visits occurring as&#xD;
      per clinical practice (usually once monthly).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Persistence (number of days) with aripiprazole once-monthly treatment</measure>
    <time_frame>During the first 6 months after aripiprazole once-monthly initiation.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.</measure>
    <time_frame>Through study completion, at least 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)</measure>
    <time_frame>Through study completion, at least 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Clinical Global Impressions - Severity scale (CGI-S) changes</measure>
    <time_frame>Through study completion, at least 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of the schizophrenia dimensions of the participating subjects according to the Lifetime Dimensions for Psychosis Scale (LDPS) questionnaire.</measure>
    <time_frame>Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of the psychotic spectrum of the participating subjects according to Structured Clinical Interview for the Psychotic Spectrum (SCI-PSY) questionnaire.</measure>
    <time_frame>Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">262</enrollment>
  <condition>Schizophrenia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients will include adult patients with schizophrenia who initiated aripiprazole&#xD;
        once-monthly treatment as per normal clinical practice at least 6 months before data&#xD;
        collection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (age ≥ 18 years at the time of aripiprazole once-monthly initiation)&#xD;
&#xD;
          2. Male or female&#xD;
&#xD;
          3. Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, Fifth edition (DSM-5), available at start of aripiprazole once-monthly&#xD;
             treatment, and confirmed by the current investigator&#xD;
&#xD;
          4. Aripiprazole once-monthly initiation (at least 1 injection) according to the clinical&#xD;
             practice, at least 6 months before the inclusion and on June 1st 2015 or at a later&#xD;
             date (index date)&#xD;
&#xD;
          5. Aripiprazole once-monthly was the main antipsychotic at the time of treatment&#xD;
             initiation&#xD;
&#xD;
          6. Willingness to participate in the study; subjects must give their written consent to&#xD;
             participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient has a psychiatric disorder other than schizophrenia as primary diagnosis&#xD;
&#xD;
          2. Participation in a clinical trial during the retrospective follow-up period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Department</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Europe</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Salute Mentale</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPDC ASST Spedali Civili</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Cagliari</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico &quot;G. Rodolico&quot;</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Mater Domini</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa Di Cura Neuropsichiatrica Villa Von Siebenthal</name>
      <address>
        <city>Genzano di Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maria S.S. dello splendore</name>
      <address>
        <city>Giulianova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL Lecce</name>
      <address>
        <city>Lecce</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Fatebenefratelli e Oftalmico</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Gerardo</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCDU Psichiatria. AOU San Luigi Gonzaga</name>
      <address>
        <city>Orbassano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Psichiatrica. Università di Palermo</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi di Perugia</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Salute Mentale</name>
      <address>
        <city>Pomezia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL Salerno</name>
      <address>
        <city>Pontecagnano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda ULSS 9 Treviso</name>
      <address>
        <city>Treviso</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>July 14, 2017</last_update_submitted>
  <last_update_submitted_qc>July 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>persistence</keyword>
  <keyword>long-acting injectable antipsychotic</keyword>
  <keyword>adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005769
org study id: 031-306-00108
nct id: NCT03005769
lead sponsor: 
has dmc: No
This is an observational, retrospective, non-interventional study that will include
      schizophrenic patients who were initiated with aripiprazole once-monthly as per normal
      clinical practice at least 6 months before the data collection starts (inclusion visit), and
      is designed to evaluate demographic and clinical predictors of persistence with this
      treatment.

      Data from each patient will be collected after informed consent is signed (inclusion visit),
      and will include retrospective information from the start of aripiprazole once-monthly
      treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months
      after the index date). Data will be retrospectively collected from all visits occurring as
      per clinical practice (usually once monthly).
observational model: Cohort
time perspective: Retrospective
measure: Persistence (number of days) with aripiprazole once-monthly treatment
time frame: During the first 6 months after aripiprazole once-monthly initiation.
measure: Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.
time frame: Through study completion, at least 6 months.
measure: Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)
time frame: Through study completion, at least 6 months.
measure: Mean Clinical Global Impressions - Severity scale (CGI-S) changes
time frame: Through study completion, at least 6 months.
measure: Characterization of the schizophrenia dimensions of the participating subjects according to the Lifetime Dimensions for Psychosis Scale (LDPS) questionnaire.
time frame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
measure: Characterization of the psychotic spectrum of the participating subjects according to Structured Clinical Interview for the Psychotic Spectrum (SCI-PSY) questionnaire.
time frame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Department
role: Study Director
affiliation: Otsuka Europe
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country: Italy
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No