<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/NCT01705613</url>
  </required_header>
  <id_info>
    <org_study_id>100540</org_study_id>
    <secondary_id>100540</secondary_id>
    <secondary_id>U1111-1131-1903</secondary_id>
    <nct_id>NCT01705613</nct_id>
  </id_info>
  <brief_title>Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil</brief_title>
  <official_title>Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian&#xD;
      children and adolescents, submitted to methylphenidate immediate-release treatment for&#xD;
      Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale&#xD;
      (HUI) will be completed by the patient and/or family, in two moments of an observation study&#xD;
      with immediate-release methylphenidate: at the baseline and 6th month of treatment in the&#xD;
      follow-up. The results provides information to calculate the utility measure and determine&#xD;
      the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the&#xD;
      treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation&#xD;
      with 10,000 random trials.&#xD;
&#xD;
      Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose&#xD;
      of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be&#xD;
      evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by&#xD;
      parents and patients (if &gt;12 years old only) at baseline and 6th month. The period for&#xD;
      inclusion of new patients comprises from 01/01/2011 to 31/12/2013.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, Brazil has no estimates for quality of life, and/or utilities for ADHD economy&#xD;
      analysis. Such data is necessary to calculate the QALYs (Quality Adjusted Life Years). Thus,&#xD;
      the investigators will implement the Health Utility Index tool (HUI) to be completed by the&#xD;
      patient and/or family, in two moments of an observational study with immediate-release&#xD;
      methylphenidate: at baseline and 6th month of treatment. The determination of the QALY as an&#xD;
      outcome in the decision analysis is justified because HUI incorporates into a single measure&#xD;
      morbidity and mortality. The results of the cost-effectiveness study will assist government&#xD;
      agencies in the process of decision making.&#xD;
&#xD;
      To determine the cost-effectiveness of methylphenidate immediate release available in the&#xD;
      Brazilian market, the investigators will use a Markov model of decision analysis. The&#xD;
      development of the model and analysis of the results will adopt the standards established in&#xD;
      the Methodological Guidelines of the Brazilian Ministry of Health, and the perspective will&#xD;
      be of the Brazilian National Health System. Medications prices will be obtained through the&#xD;
      Board of Market Regulation of Medicines (CMED) at the site of ANVISA (National Health&#xD;
      Surveillance Agency). For the treatment strategy that provides greatest cost ratio it will be&#xD;
      calculated the incremental cost-effectiveness, compared to the lower cost. To estimate more&#xD;
      accurately the impact on life, a Monte Carlo simulation with 10,000 random trials will be&#xD;
      conducted.&#xD;
&#xD;
      This is a one treatment group and observational study, with 140 patients, and no controls.&#xD;
      Where indicated, it will be suggested the use of 10 mg methylphenidate in a maximum dose of&#xD;
      0.5 mg / kg / day. The total treatment monitoring is 06 (six) months, and patients will be&#xD;
      evaluated at baseline, first, third and sixth month. The HUI rating scales will be fulfilled&#xD;
      by parents and patients (if &gt;12 years old only) at baseline and 6th month. The period for&#xD;
      inclusion of new patients comprises from 01/01/2011 to 31/12/2013.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)</measure>
    <time_frame>Baseline, 1th, 3rd and 6th month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Utility Index</measure>
    <time_frame>Baseline and 6th month</time_frame>
  </primary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Attention Deficit/Hyperactivity Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adolescents with indication of Attention Deficit/Hyperactivity Disorder&#xD;
        treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptoms of attention deficit/hyperactivity disorder with impairment&#xD;
&#xD;
          -  Children and adolescents (age from 06 to 18 years old)&#xD;
&#xD;
          -  absence of contraindication for the use of methylphenidate immediate release&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication methylphenidate immediate release use&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
          -  Discordance with the informed consent form&#xD;
&#xD;
          -  IQ&lt;70&#xD;
&#xD;
          -  Neurological diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis A Rohde, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos R Moreira Maia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>April 10, 2014</last_update_submitted>
  <last_update_submitted_qc>April 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>larohde</investigator_full_name>
    <investigator_title>Luis Augusto Paim Rohde</investigator_title>
  </responsible_party>
  <keyword>Attention Deficit/Hyperactivity Disorder</keyword>
  <keyword>ADHD</keyword>
  <keyword>Methylphenidate Immediate-release</keyword>
  <keyword>Cost-effectiveness</keyword>
  <keyword>Cost-utility</keyword>
  <keyword>QALYs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705613
org study id: 100540
secondary id: 100540
secondary id: U1111-1131-1903
nct id: NCT01705613
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian
      children and adolescents, submitted to methylphenidate immediate-release treatment for
      Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale
      (HUI) will be completed by the patient and/or family, in two moments of an observation study
      with immediate-release methylphenidate: at the baseline and 6th month of treatment in the
      follow-up. The results provides information to calculate the utility measure and determine
      the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the
      treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation
      with 10,000 random trials.

      Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose
      of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be
      evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by
      parents and patients (if >12 years old only) at baseline and 6th month. The period for
      inclusion of new patients comprises from 01/01/2011 to 31/12/2013.
Currently, Brazil has no estimates for quality of life, and/or utilities for ADHD economy
      analysis. Such data is necessary to calculate the QALYs (Quality Adjusted Life Years). Thus,
      the investigators will implement the Health Utility Index tool (HUI) to be completed by the
      patient and/or family, in two moments of an observational study with immediate-release
      methylphenidate: at baseline and 6th month of treatment. The determination of the QALY as an
      outcome in the decision analysis is justified because HUI incorporates into a single measure
      morbidity and mortality. The results of the cost-effectiveness study will assist government
      agencies in the process of decision making.

      To determine the cost-effectiveness of methylphenidate immediate release available in the
      Brazilian market, the investigators will use a Markov model of decision analysis. The
      development of the model and analysis of the results will adopt the standards established in
      the Methodological Guidelines of the Brazilian Ministry of Health, and the perspective will
      be of the Brazilian National Health System. Medications prices will be obtained through the
      Board of Market Regulation of Medicines (CMED) at the site of ANVISA (National Health
      Surveillance Agency). For the treatment strategy that provides greatest cost ratio it will be
      calculated the incremental cost-effectiveness, compared to the lower cost. To estimate more
      accurately the impact on life, a Monte Carlo simulation with 10,000 random trials will be
      conducted.

      This is a one treatment group and observational study, with 140 patients, and no controls.
      Where indicated, it will be suggested the use of 10 mg methylphenidate in a maximum dose of
      0.5 mg / kg / day. The total treatment monitoring is 06 (six) months, and patients will be
      evaluated at baseline, first, third and sixth month. The HUI rating scales will be fulfilled
      by parents and patients (if >12 years old only) at baseline and 6th month. The period for
      inclusion of new patients comprises from 01/01/2011 to 31/12/2013.
observational model: Ecologic or Community
time perspective: Prospective
measure: Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
time frame: Baseline, 1th, 3rd and 6th month
measure: Health Utility Index
time frame: Baseline and 6th month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Luis A Rohde, MD, PhD
role: Study Chair
affiliation: Hospital de Clinicas de Porto Alegre
last name: Carlos R Moreira Maia, MD
role: Principal Investigator
affiliation: Hospital de Clinicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: larohde
investigator title: Luis Augusto Paim Rohde
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity