<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/NCT01677819</url>
  </required_header>
  <id_info>
    <org_study_id>201109027RD</org_study_id>
    <nct_id>NCT01677819</nct_id>
  </id_info>
  <brief_title>Inhibition Control of Children and Adolescents With ADHD</brief_title>
  <official_title>Inhibition Control of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to investigate:&#xD;
&#xD;
        1. the effect of methylphenidate on attention;&#xD;
&#xD;
        2. the relations between methylphenidate and inhibition control and working memory;&#xD;
&#xD;
        3. the relations between inhibition control and verbal attention and working memory;&#xD;
&#xD;
        4. the effect of methylphenidate on the changes of neuropsychological functioning and blood&#xD;
           pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity&#xD;
      and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term&#xD;
      impairing disorder with tremendous impact on individuals, families, and societies. It affects&#xD;
      5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is&#xD;
      effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on&#xD;
      blood pressure. There are evidences show that the change of blood pressure was associated&#xD;
      with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve&#xD;
      of inhibition control after methylphenidate response. By using repeated outcome measurements,&#xD;
      we anticipate that this study will evaluate the improvement of neuropsychological&#xD;
      performances after medication and determinie the association between medication response and&#xD;
      neuropsychological functions and vital signs in a Taiwanese sample.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <enrollment type="Actual">60</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit 60 children and adolescents, aged 10 to 18, who are diagnosed with ADHD at&#xD;
        the Department of Psychiatry, National Taiwan University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of&#xD;
        ADHD defined by the DSM-IV which was made by a full-time board-certificated child&#xD;
        psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their IQ&#xD;
        greater than 80; and (4)they are under treatment of methylphenidate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The subjects will be excluded from the study if they currently meet criteria or have a&#xD;
        history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective&#xD;
        Disorder, Organic Psychosis, or Pervasive Developmental Disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shur-Fen Gau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital &amp; College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan Univeristy Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>Susan Shur-Fen Gau</investigator_title>
  </responsible_party>
  <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/NCT01677819
org study id: 201109027RD
nct id: NCT01677819
lead sponsor: 
has dmc: Yes
The objectives of this study are to investigate:

        1. the effect of methylphenidate on attention;

        2. the relations between methylphenidate and inhibition control and working memory;

        3. the relations between inhibition control and verbal attention and working memory;

        4. the effect of methylphenidate on the changes of neuropsychological functioning and blood
           pressure.
Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity
      and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term
      impairing disorder with tremendous impact on individuals, families, and societies. It affects
      5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is
      effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on
      blood pressure. There are evidences show that the change of blood pressure was associated
      with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve
      of inhibition control after methylphenidate response. By using repeated outcome measurements,
      we anticipate that this study will evaluate the improvement of neuropsychological
      performances after medication and determinie the association between medication response and
      neuropsychological functions and vital signs in a Taiwanese sample.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Susan Shur-Fen Gau, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital & College of Medicine
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: Susan Shur-Fen Gau
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity