<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/NCT02255565</url>
  </required_header>
  <id_info>
    <org_study_id>WI185890</org_study_id>
    <nct_id>NCT02255565</nct_id>
  </id_info>
  <brief_title>Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study</brief_title>
  <official_title>Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Quillivant XR is effective in the treatment&#xD;
      of ADHD in children with Autism Spectrum Disorder (ASD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR&#xD;
      (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in&#xD;
      children with ASD and ADHD. The investigators propose to investigate the low to moderate dose&#xD;
      range of methylphenidate compared with a very low dose with a gradual dose escalation&#xD;
      schedule because children with ASD have been found to be more sensitive to the adverse&#xD;
      effects of methylphenidate (especially in medium to high doses) than children without ASD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADHD Rating Scale - IV</measure>
    <time_frame>once a week for 6 weeks</time_frame>
    <description>Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions-ADHD - Severity</measure>
    <time_frame>once a week for 6 weeks</time_frame>
    <description>The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement (CGI-I)</measure>
    <time_frame>once a week for 6 weeks</time_frame>
    <description>The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>ADHD</condition>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Very Low Dose Quillivant XR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose Quillivant XR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate dose Quillivant XR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Very Low Dose Quillivant XR</intervention_name>
    <description>Oral suspension dose once a day increasing to a 10mg dose</description>
    <arm_group_label>Very Low Dose Quillivant XR</arm_group_label>
    <other_name>Methylphenidate HCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Dose Quillivant XR</intervention_name>
    <description>Oral suspension dose once a day increasing to a 20mg dose</description>
    <arm_group_label>Low Dose Quillivant XR</arm_group_label>
    <other_name>Methylphenidate HCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moderate Dose Quillivant XR</intervention_name>
    <description>Oral suspension dose once a day increasing to a 40mg dose</description>
    <arm_group_label>Moderate dose Quillivant XR</arm_group_label>
    <other_name>Methylphenidate HCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism&#xD;
             Spectrum Disorder by DSM-V.&#xD;
&#xD;
          -  A DSM-V diagnosis of ADHD based upon the K-SADS-P.&#xD;
&#xD;
          -  Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating &gt; 4.&#xD;
&#xD;
          -  Findings on physical exam, labs and ECG are judged to be normal for age with pulse and&#xD;
             blood pressure within 95% of age and gender mean.&#xD;
&#xD;
          -  Informed consent by a parent or legal guardian, and assent for children with&#xD;
             developmental age 7 years or older.&#xD;
&#xD;
          -  At least one parent fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Seizure disorder (Febrile seizures are non-exclusionary).&#xD;
&#xD;
          -  History of Intellectual Disability (IQ&lt; 70)&#xD;
&#xD;
          -  Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO&#xD;
             Inhibitor).&#xD;
&#xD;
          -  Other psychotropic medication other than stable dose of Selective Serotonin Reuptake&#xD;
             Inhibitors, which is permitted)&#xD;
&#xD;
          -  Known to be hypersensitive to methylphenidate, or other components of Quillivant XR&#xD;
&#xD;
          -  Cardiac or other medical contraindications for stimulant trial (e.g., family history&#xD;
             of heart attack at age younger than 40 years, personal history of heart disease,&#xD;
             history of fainting while exercising, structural cardiac abnormalities,&#xD;
             cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious&#xD;
             cardiac problems. If any doubt, children will be referred to a cardiologist for a&#xD;
             cardiac clearance.&#xD;
&#xD;
          -  Raynaud's disease&#xD;
&#xD;
          -  Pregnancy or Breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Stein, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gadow KD, DeVincent CJ, Pomeroy J. ADHD symptom subtypes in children with pervasive developmental disorder. J Autism Dev Disord. 2006 Feb;36(2):271-83. doi: 10.1007/s10803-005-0060-3.</citation>
    <PMID>16477513</PMID>
  </reference>
  <reference>
    <citation>Lee DO, Ousley OY. Attention-deficit hyperactivity disorder symptoms in a clinic sample of children and adolescents with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Dec;16(6):737-46. doi: 10.1089/cap.2006.16.737.</citation>
    <PMID>17201617</PMID>
  </reference>
  <reference>
    <citation>Rao, P. A. and R. J. Landa (2013).</citation>
  </reference>
  <reference>
    <citation>Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry. 2005 Nov;62(11):1266-74. doi: 10.1001/archpsyc.62.11.1266.</citation>
    <PMID>16275814</PMID>
  </reference>
  <reference>
    <citation>Stein, M.A. et al.</citation>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>March 7, 2017</results_first_submitted>
  <results_first_submitted_qc>April 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 5, 2017</results_first_posted>
  <last_update_submitted>July 3, 2017</last_update_submitted>
  <last_update_submitted_qc>July 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Mark Stein</investigator_full_name>
    <investigator_title>Director of ADHD/Related Disorders Program</investigator_title>
  </responsible_party>
  <keyword>Quillivant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylphenidate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible participants were recruited from the investigators' practices, clinic referrals, and letter mailings. Participants were enrolled between September 2014 and September 2016.</recruitment_details>
      <pre_assignment_details>Of the 36 participants enrolled, 27 were randomized to receive treatment. 3 participants withdrew, 2 due to time commitment issues and 1 due to stress over screening. 6 participants were deemed ineligible for the study due to no Autism Spectrum Disorder (ASD) diagnosis based on screening assessments.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Very Low Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
        </group>
        <group group_id="P2">
          <title>Low Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
        </group>
        <group group_id="P3">
          <title>Moderate Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</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 group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Of the 36 participants enrolled, 27 were randomized to receive treatment. 3 participants withdrew, 2 due to time commitment issues and 1 due to stress over screening. 6 participants were deemed ineligible for the study due to no Autism Spectrum Disorder (ASD) diagnosis based on screening assessments.</population>
      <group_list>
        <group group_id="B1">
          <title>Very Low Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
        </group>
        <group group_id="B2">
          <title>Low Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
        </group>
        <group group_id="B3">
          <title>Moderate Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
        </group>
        <group group_id="B4">
          <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="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="9.33" spread="2.92"/>
                    <measurement group_id="B2" value="8.00" spread="2.96"/>
                    <measurement group_id="B3" value="10.22" spread="3.03"/>
                    <measurement group_id="B4" value="9.19" spread="3.00"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="25"/>
                  </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 group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ADHD Rating Scale - IV</title>
        <description>Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.</description>
        <time_frame>once a week for 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Very Low Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O2">
            <title>Very Low Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O3">
            <title>Very Low Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O4">
            <title>Very Low Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O5">
            <title>Very Low Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O6">
            <title>Very Low Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O7">
            <title>Low Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O8">
            <title>Low Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O9">
            <title>Low Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O10">
            <title>Low Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O11">
            <title>Low Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O12">
            <title>Low Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O13">
            <title>Moderate Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O14">
            <title>Moderate Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O15">
            <title>Moderate Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O16">
            <title>Moderate Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O17">
            <title>Moderate Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O18">
            <title>Moderate Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
        </group_list>
        <measure>
          <title>ADHD Rating Scale - IV</title>
          <description>Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.</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 group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
                <count group_id="O12" value="9"/>
                <count group_id="O13" value="9"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="9"/>
                <count group_id="O17" value="9"/>
                <count group_id="O18" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Inattention Subscale Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.89" spread="3.95"/>
                    <measurement group_id="O2" value="16.78" spread="4.18"/>
                    <measurement group_id="O3" value="16.67" spread="2.74"/>
                    <measurement group_id="O4" value="14.33" spread="6.26"/>
                    <measurement group_id="O5" value="14.56" spread="5.53"/>
                    <measurement group_id="O6" value="12.89" spread="5.01"/>
                    <measurement group_id="O7" value="16.33" spread="6.89"/>
                    <measurement group_id="O8" value="14.00" spread="5.83"/>
                    <measurement group_id="O9" value="12.00" spread="5.22"/>
                    <measurement group_id="O10" value="8.38" spread="5.90"/>
                    <measurement group_id="O11" value="9.50" spread="4.57"/>
                    <measurement group_id="O12" value="9.56" spread="6.17"/>
                    <measurement group_id="O13" value="18.11" spread="4.43"/>
                    <measurement group_id="O14" value="14.67" spread="5.15"/>
                    <measurement group_id="O15" value="13.67" spread="6.98"/>
                    <measurement group_id="O16" value="13.56" spread="5.10"/>
                    <measurement group_id="O17" value="13.00" spread="5.55"/>
                    <measurement group_id="O18" value="11.78" spread="5.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperactivity Subscale Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.44" spread="7.91"/>
                    <measurement group_id="O2" value="10.56" spread="8.16"/>
                    <measurement group_id="O3" value="11.56" spread="6.25"/>
                    <measurement group_id="O4" value="12.33" spread="5.70"/>
                    <measurement group_id="O5" value="9.22" spread="7.55"/>
                    <measurement group_id="O6" value="8.78" spread="5.67"/>
                    <measurement group_id="O7" value="15.33" spread="8.23"/>
                    <measurement group_id="O8" value="14.33" spread="7.38"/>
                    <measurement group_id="O9" value="10.22" spread="5.24"/>
                    <measurement group_id="O10" value="6.88" spread="4.42"/>
                    <measurement group_id="O11" value="9.38" spread="4.75"/>
                    <measurement group_id="O12" value="6.56" spread="4.28"/>
                    <measurement group_id="O13" value="12.78" spread="3.87"/>
                    <measurement group_id="O14" value="11.33" spread="2.78"/>
                    <measurement group_id="O15" value="11.78" spread="6.26"/>
                    <measurement group_id="O16" value="9.67" spread="5.87"/>
                    <measurement group_id="O17" value="9.22" spread="5.83"/>
                    <measurement group_id="O18" value="7.33" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.33" spread="9.27"/>
                    <measurement group_id="O2" value="27.33" spread="11.14"/>
                    <measurement group_id="O3" value="28.22" spread="7.24"/>
                    <measurement group_id="O4" value="26.67" spread="10.20"/>
                    <measurement group_id="O5" value="23.78" spread="11.51"/>
                    <measurement group_id="O6" value="21.67" spread="7.78"/>
                    <measurement group_id="O7" value="31.67" spread="14.67"/>
                    <measurement group_id="O8" value="28.33" spread="12.41"/>
                    <measurement group_id="O9" value="22.22" spread="9.90"/>
                    <measurement group_id="O10" value="15.25" spread="9.77"/>
                    <measurement group_id="O11" value="18.88" spread="9.06"/>
                    <measurement group_id="O12" value="16.11" spread="8.99"/>
                    <measurement group_id="O13" value="30.89" spread="6.17"/>
                    <measurement group_id="O14" value="26.00" spread="5.87"/>
                    <measurement group_id="O15" value="25.44" spread="12.70"/>
                    <measurement group_id="O16" value="23.22" spread="10.02"/>
                    <measurement group_id="O17" value="22.22" spread="10.03"/>
                    <measurement group_id="O18" value="19.11" spread="7.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impressions-ADHD - Severity</title>
        <description>The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.</description>
        <time_frame>once a week for 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Very Low Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O2">
            <title>Very Low Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O3">
            <title>Very Low Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O4">
            <title>Very Low Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O5">
            <title>Very Low Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O6">
            <title>Very Low Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O7">
            <title>Low Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O8">
            <title>Low Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O9">
            <title>Low Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O10">
            <title>Low Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O11">
            <title>Low Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O12">
            <title>Low Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O13">
            <title>Moderate Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O14">
            <title>Moderate Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O15">
            <title>Moderate Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O16">
            <title>Moderate Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O17">
            <title>Moderate Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O18">
            <title>Moderate Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impressions-ADHD - Severity</title>
          <description>The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.</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 group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
                <count group_id="O12" value="9"/>
                <count group_id="O13" value="9"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="9"/>
                <count group_id="O17" value="9"/>
                <count group_id="O18" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.78" spread="0.44"/>
                    <measurement group_id="O2" value="4.33" spread="0.87"/>
                    <measurement group_id="O3" value="4.44" spread="0.88"/>
                    <measurement group_id="O4" value="4.33" spread="0.87"/>
                    <measurement group_id="O5" value="4.11" spread="1.05"/>
                    <measurement group_id="O6" value="4.00" spread="0.87"/>
                    <measurement group_id="O7" value="4.33" spread="1.12"/>
                    <measurement group_id="O8" value="4.00" spread="1.22"/>
                    <measurement group_id="O9" value="3.67" spread="1.00"/>
                    <measurement group_id="O10" value="2.75" spread="1.16"/>
                    <measurement group_id="O11" value="2.88" spread="1.25"/>
                    <measurement group_id="O12" value="2.78" spread="1.30"/>
                    <measurement group_id="O13" value="4.89" spread="0.33"/>
                    <measurement group_id="O14" value="4.56" spread="0.53"/>
                    <measurement group_id="O15" value="4.11" spread="0.60"/>
                    <measurement group_id="O16" value="4.00" spread="0.71"/>
                    <measurement group_id="O17" value="3.56" spread="0.88"/>
                    <measurement group_id="O18" value="3.44" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression - Improvement (CGI-I)</title>
        <description>The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.</description>
        <time_frame>once a week for 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Very Low Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O2">
            <title>Very Low Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O3">
            <title>Very Low Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O4">
            <title>Very Low Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O5">
            <title>Very Low Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O6">
            <title>Very Low Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
          </group>
          <group group_id="O7">
            <title>Low Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O8">
            <title>Low Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O9">
            <title>Low Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O10">
            <title>Low Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O11">
            <title>Low Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O12">
            <title>Low Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
          </group>
          <group group_id="O13">
            <title>Moderate Dose Quillivant XR - Week 1</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O14">
            <title>Moderate Dose Quillivant XR - Week 2</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O15">
            <title>Moderate Dose Quillivant XR - Week 3</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O16">
            <title>Moderate Dose Quillivant XR - Week 4</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O17">
            <title>Moderate Dose Quillivant XR - Week 5</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
          <group group_id="O18">
            <title>Moderate Dose Quillivant XR - Week 6</title>
            <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression - Improvement (CGI-I)</title>
          <description>The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing 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 group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
                <count group_id="O12" value="9"/>
                <count group_id="O13" value="9"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="9"/>
                <count group_id="O17" value="9"/>
                <count group_id="O18" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.89" spread="0.60"/>
                    <measurement group_id="O2" value="3.56" spread="0.88"/>
                    <measurement group_id="O3" value="3.44" spread="0.53"/>
                    <measurement group_id="O4" value="3.22" spread="0.83"/>
                    <measurement group_id="O5" value="3.00" spread="1.00"/>
                    <measurement group_id="O6" value="2.89" spread="0.78"/>
                    <measurement group_id="O7" value="3.78" spread="1.30"/>
                    <measurement group_id="O8" value="3.00" spread="0.87"/>
                    <measurement group_id="O9" value="2.22" spread="0.83"/>
                    <measurement group_id="O10" value="1.63" spread="0.74"/>
                    <measurement group_id="O11" value="2.13" spread="0.99"/>
                    <measurement group_id="O12" value="2.00" spread="0.87"/>
                    <measurement group_id="O13" value="3.33" spread="0.50"/>
                    <measurement group_id="O14" value="3.11" spread="0.60"/>
                    <measurement group_id="O15" value="2.67" spread="1.12"/>
                    <measurement group_id="O16" value="2.89" spread="0.60"/>
                    <measurement group_id="O17" value="2.56" spread="1.01"/>
                    <measurement group_id="O18" value="2.22" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.</time_frame>
      <desc>At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.</desc>
      <group_list>
        <group group_id="E1">
          <title>Very Low Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.&#xD;
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose</description>
        </group>
        <group group_id="E2">
          <title>Low Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.&#xD;
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose</description>
        </group>
        <group group_id="E3">
          <title>Moderate Dose Quillivant XR</title>
          <description>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.&#xD;
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>RISK</default_vocab>
        <default_assessment>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="8" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Infrequent bowel movements</description>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Throwing up</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Difficulty Falling Asleep</sub_title>
                <counts group_id="E1" events="17" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" events="17" subjects_affected="6" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Waking at Night</sub_title>
                <description>Difficulty remaining asleep throughout the night</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Waking up Early</sub_title>
                <description>Premature awakening in the morning, is too alert to resume sleeping after waking</description>
                <counts group_id="E1" events="9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="16" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nightmares</sub_title>
                <description>Distressing dreams</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Talks less</sub_title>
                <description>Child talks less than is normal for him/her.</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Uninterested</sub_title>
                <description>Child appears not to be interested in things or people around him/her</description>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <description>Reduction in the intensity or frequency of hunger; a reduced desire to eat</description>
                <counts group_id="E1" events="9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="13" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" events="13" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Irritable</sub_title>
                <description>Easily irritated or annoyed</description>
                <counts group_id="E1" events="22" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" events="11" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hostility</sub_title>
                <description>Showing antagonism and opposition towards people and/or circumstances</description>
                <counts group_id="E1" events="18" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Stomachaches</sub_title>
                <description>Persistent pain localized in the stomach area</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Headaches</sub_title>
                <description>Persistent physical pain in the child's head</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <description>An irresistible urge to fall asleep at inappropriate times</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Sad/Unhappy</sub_title>
                <description>Child appears inappropriately sad (moods is not congruent with setting or circumstance)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Prone to Crying</sub_title>
                <description>Cries easily or often</description>
                <counts group_id="E1" events="12" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Anxious/worries</sub_title>
                <description>Apprehension, fear, concern, or dread</description>
                <counts group_id="E1" events="11" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Bites Fingernails</sub_title>
                <description>Child bites fingernails or cuticles</description>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Picking</sub_title>
                <description>Child picks at skin, cuticles, fingernails, etc.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="9" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Euphoric/Happy</sub_title>
                <description>Child appears inappropriately happy (mood is not congruent with setting or circumstance)</description>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" events="9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>The urge to vomit; child feels like he/she might vomit</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Jittery or nervous</sub_title>
                <description>An edgy, tense state; is easily agitated or anxious</description>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Mood Swings/Lability</sub_title>
                <description>Unpredictable or easily changeable moods; unstable moods or emotions</description>
                <counts group_id="E1" events="17" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <description>A reduction of strength or energy</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Stares A Lot</sub_title>
                <description>Child frequently has a fixed look with his/her wide open, looks into space</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <description>Persistent pain localized in the abdomen</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <description>Skin becomes reddened, itchy, and/or raised (not due to an insect bite)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="9" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Cold Hands and Feet</sub_title>
                <description>Hands and feet are cold to the touch</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Flat Affect / No Emotion</sub_title>
                <description>Complete (or nearly complete) absence of emotional expression.</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rebound at end of day</sub_title>
                <description>An intensification of ADHD symptoms at the end of the day</description>
                <counts group_id="E1" events="16" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" events="19" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" events="15" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <description>Behaving in an actively hostile manner</description>
                <counts group_id="E1" events="16" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Tics</sub_title>
                <description>Child makes repetitive, uncontrollable movements or sounds</description>
                <counts group_id="E1" events="8" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" events="4" 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>
    <limitations_and_caveats>No placebo was available for comparison to Quillivant XR. Small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Mark Stein</name_or_title>
      <organization>Dept. of Psychiatry, University of Washington</organization>
      <phone>206-987-1161</phone>
      <email>mstein42@uw.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/NCT02255565
org study id: WI185890
nct id: NCT02255565
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether Quillivant XR is effective in the treatment
      of ADHD in children with Autism Spectrum Disorder (ASD).
To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR
      (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in
      children with ASD and ADHD. The investigators propose to investigate the low to moderate dose
      range of methylphenidate compared with a very low dose with a gradual dose escalation
      schedule because children with ASD have been found to be more sensitive to the adverse
      effects of methylphenidate (especially in medium to high doses) than children without ASD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: ADHD Rating Scale - IV
time frame: once a week for 6 weeks
description: Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
measure: Clinical Global Impressions-ADHD - Severity
time frame: once a week for 6 weeks
description: The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
measure: Clinical Global Impression - Improvement (CGI-I)
time frame: once a week for 6 weeks
description: The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
arm group label: Very Low Dose Quillivant XR
arm group type: Experimental
description: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
arm group label: Low Dose Quillivant XR
arm group type: Experimental
description: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
arm group label: Moderate dose Quillivant XR
arm group type: Experimental
description: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
intervention type: Drug
intervention name: Very Low Dose Quillivant XR
description: Oral suspension dose once a day increasing to a 10mg dose
arm group label: Very Low Dose Quillivant XR
other name: Methylphenidate HCl
intervention type: Drug
intervention name: Low Dose Quillivant XR
description: Oral suspension dose once a day increasing to a 20mg dose
arm group label: Low Dose Quillivant XR
other name: Methylphenidate HCl
intervention type: Drug
intervention name: Moderate Dose Quillivant XR
description: Oral suspension dose once a day increasing to a 40mg dose
arm group label: Moderate dose Quillivant XR
other name: Methylphenidate HCl
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Mark Stein, PhD
role: Principal Investigator
affiliation: Seattle Children's
facility: 
country: United States
citation: Gadow KD, DeVincent CJ, Pomeroy J. ADHD symptom subtypes in children with pervasive developmental disorder. J Autism Dev Disord. 2006 Feb;36(2):271-83. doi: 10.1007/s10803-005-0060-3.
PMID: 16477513
citation: Lee DO, Ousley OY. Attention-deficit hyperactivity disorder symptoms in a clinic sample of children and adolescents with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Dec;16(6):737-46. doi: 10.1089/cap.2006.16.737.
PMID: 17201617
citation: Rao, P. A. and R. J. Landa (2013).
citation: Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry. 2005 Nov;62(11):1266-74. doi: 10.1001/archpsyc.62.11.1266.
PMID: 16275814
citation: Stein, M.A. et al.
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Mark Stein
investigator title: Director of ADHD/Related Disorders Program
mesh term: Autistic Disorder
mesh term: Methylphenidate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No placebo was available for comparison to Quillivant XR. Small sample size.
point of contact: 