<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/NCT01725737</url>
  </required_header>
  <id_info>
    <org_study_id>09MMHIS178</org_study_id>
    <secondary_id>09MMHIS178</secondary_id>
    <nct_id>NCT01725737</nct_id>
  </id_info>
  <brief_title>Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)</brief_title>
  <official_title>Placebo-Controlled Trial With GlyTI-M Among Children With ADHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity&#xD;
      Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current&#xD;
      medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant.&#xD;
      We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This&#xD;
      study will also help us to understand the mechanism of ADHD and give a way to develop new&#xD;
      drug and also a more possible way to treat ADHD children under 6 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The accumulated neuro-image, hereditary and animal studies showed the correlation between&#xD;
      glutamate transport dysfunction and ADHD psychopathology. However, there is limited clinical&#xD;
      trial to testify the effect of modulating the NMDA receptor function of glutamate to treat&#xD;
      ADHD.&#xD;
&#xD;
      GlyTI-M is an endogenous Glycine transporter I inhibitor, and it acts on the glutamatergic&#xD;
      synapse to modulate the neurotransmission of N-Methyl-D-Aspertate (NMDA) receptor. This study&#xD;
      aims to explore the effect of GlyTI-M among children with ADHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)</measure>
    <time_frame>1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week</time_frame>
    <description>Change in inattention score of SNAP-IV-C&#xD;
Change in hyperactivity/impulsivity score of SNAP-IV-C&#xD;
Change in oppositional defiant disorder score of SNAP-IV-C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barkley's side effect rating scale</measure>
    <time_frame>1. Change from Baseline adverse effect at 2, 4, 6 weeks</time_frame>
    <description>Change from Baseline adverse effect at 2 weeks&#xD;
Change from Baseline adverse effect at 4 weeks&#xD;
Change from Baseline adverse effect at 6 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GlyTI-M</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GlyTI-M: 0.03gm/kg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GlyTI-M</intervention_name>
    <arm_group_label>GlyTI-M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Comparator: starch</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfill the criteria of ADHD according to the Diagnostic and Statistic Manual, fourth&#xD;
             edition (DSM-IV).&#xD;
&#xD;
          -  Subjects and parents agree to participate in the study and provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Autism, Mental retardation.&#xD;
&#xD;
          -  inability to follow protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruu-Fen Tzang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mackay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>111</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>July 14, 2013</last_update_submitted>
  <last_update_submitted_qc>July 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Ruu-Fen Tzang</investigator_full_name>
    <investigator_title>attending physician</investigator_title>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>GlyTI-M</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01725737
org study id: 09MMHIS178
secondary id: 09MMHIS178
nct id: NCT01725737
lead sponsor: 
has dmc: Yes
Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity
      Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current
      medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant.
      We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This
      study will also help us to understand the mechanism of ADHD and give a way to develop new
      drug and also a more possible way to treat ADHD children under 6 years old.
The accumulated neuro-image, hereditary and animal studies showed the correlation between
      glutamate transport dysfunction and ADHD psychopathology. However, there is limited clinical
      trial to testify the effect of modulating the NMDA receptor function of glutamate to treat
      ADHD.

      GlyTI-M is an endogenous Glycine transporter I inhibitor, and it acts on the glutamatergic
      synapse to modulate the neurotransmission of N-Methyl-D-Aspertate (NMDA) receptor. This study
      aims to explore the effect of GlyTI-M among children with ADHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)
time frame: 1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week
description: Change in inattention score of SNAP-IV-C
Change in hyperactivity/impulsivity score of SNAP-IV-C
Change in oppositional defiant disorder score of SNAP-IV-C
measure: Barkley's side effect rating scale
time frame: 1. Change from Baseline adverse effect at 2, 4, 6 weeks
description: Change from Baseline adverse effect at 2 weeks
Change from Baseline adverse effect at 4 weeks
Change from Baseline adverse effect at 6 weeks
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: GlyTI-M
arm group type: Active Comparator
description: GlyTI-M: 0.03gm/kg/day
intervention type: Drug
intervention name: GlyTI-M
arm group label: GlyTI-M
intervention type: Drug
intervention name: Placebo
description: Placebo Comparator: starch
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Ruu-Fen Tzang, M.D.
role: Principal Investigator
affiliation: Mackay Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Ruu-Fen Tzang
investigator title: attending physician
mesh term: Attention Deficit Disorder with Hyperactivity