<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/NCT01675804</url>
  </required_header>
  <id_info>
    <org_study_id>83-6516</org_study_id>
    <nct_id>NCT01675804</nct_id>
  </id_info>
  <brief_title>Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD</brief_title>
  <official_title>A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allameh Tabatabai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allameh Tabatabai University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation&#xD;
      (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of&#xD;
      children with attention deficit/hyperactivity disorder (ADHD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators administered a randomized controlled trial (RCT) through random assignment&#xD;
      of ADHD subjects in to three different groups to compare the effects of CACR,&#xD;
      immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed&#xD;
      not having any therapeutic effects) on the functioning of children with ADHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Persian software for the continuous performance test [CPT]</measure>
    <time_frame>5 months</time_frame>
    <description>The Persian software of CPT is a visual CPT test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persian software for the Tower of London Test [TOL]</measure>
    <time_frame>5 months</time_frame>
    <description>Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forward/Reversed digit span tasks from the WISC-R testing battery.</measure>
    <time_frame>5 months</time_frame>
    <description>Reversed digit span from the WISC-R (Wechsler, 1974) was used to measure executive verbal WM and the forward digit span was used to measure short-term memory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Raven's colored progressive matrices.</measure>
    <time_frame>5 months</time_frame>
    <description>Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Span board task from the Lumosity.com online software (Lumosity.com, 2012)</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>SNAP-IV scales</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Attention Deficit Disorder With Hyperactivity</condition>
  <arm_group>
    <arm_group_label>Computerized cognitive rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo CACR [PCACR]</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ritalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>-2 to 3 doses of 10 mg Ritalin tablets per day during two months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized cognitive rehabilitation</intervention_name>
    <description>- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.</description>
    <arm_group_label>Computerized cognitive rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritalin</intervention_name>
    <description>-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.</description>
    <arm_group_label>Ritalin</arm_group_label>
    <other_name>Immediate release methylphenidate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo CACR [PCACR]</intervention_name>
    <description>PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.</description>
    <arm_group_label>Placebo CACR [PCACR]</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ADHD diagnosis&#xD;
&#xD;
          -  age between 7 and 12&#xD;
&#xD;
          -  IQ &gt; 85&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sever co-morbid disorder&#xD;
&#xD;
          -  seizure&#xD;
&#xD;
          -  IQ &lt; 85&#xD;
&#xD;
          -  disability&#xD;
&#xD;
          -  sever medical condition&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saeed Azami, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alireza Moghadas, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Faramarz Sohrabi, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Morteza Nazifi, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of psychology, University of Bojnord, Bojnord, Iran.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Counseling and guidence Center of the Department of education of region 9 of Tehran</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>July 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>April 3, 2015</last_update_submitted>
  <last_update_submitted_qc>April 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylphenidate</mesh_term>
  </intervention_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/NCT01675804
org study id: 83-6516
nct id: NCT01675804
lead sponsor: 
has dmc: No
Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation
      (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of
      children with attention deficit/hyperactivity disorder (ADHD).
The investigators administered a randomized controlled trial (RCT) through random assignment
      of ADHD subjects in to three different groups to compare the effects of CACR,
      immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed
      not having any therapeutic effects) on the functioning of children with ADHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Persian software for the continuous performance test [CPT]
time frame: 5 months
description: The Persian software of CPT is a visual CPT test.
measure: Persian software for the Tower of London Test [TOL]
time frame: 5 months
description: Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.
measure: Forward/Reversed digit span tasks from the WISC-R testing battery.
time frame: 5 months
description: Reversed digit span from the WISC-R (Wechsler, 1974) was used to measure executive verbal WM and the forward digit span was used to measure short-term memory.
measure: Raven's colored progressive matrices.
time frame: 5 months
description: Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.
measure: Span board task from the Lumosity.com online software (Lumosity.com, 2012)
time frame: 5 months
measure: SNAP-IV scales
time frame: 5 months
arm group label: Computerized cognitive rehabilitation
arm group type: Experimental
description: -Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.
arm group label: Placebo CACR [PCACR]
arm group type: Placebo Comparator
description: -PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.
arm group label: Ritalin
arm group type: Experimental
description: -2 to 3 doses of 10 mg Ritalin tablets per day during two months.
intervention type: Other
intervention name: Computerized cognitive rehabilitation
description: - Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.
arm group label: Computerized cognitive rehabilitation
intervention type: Drug
intervention name: Ritalin
description: -drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.
arm group label: Ritalin
other name: Immediate release methylphenidate
intervention type: Other
intervention name: Placebo CACR [PCACR]
description: PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.
arm group label: Placebo CACR [PCACR]
criteria: 
gender: Male
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: No
last name: Saeed Azami, MSc
role: Principal Investigator
affiliation: Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran
last name: Alireza Moghadas, PhD
role: Study Director
affiliation: Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
last name: Faramarz Sohrabi, PhD
role: Study Director
affiliation: Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
last name: Morteza Nazifi, PhD
role: Study Director
affiliation: Department of psychology, University of Bojnord, Bojnord, Iran.
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Methylphenidate