<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210222050450N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Ritalin on the influence of emotion on behavioral inhibition in children with ADHD</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Ritalin on the influence of emotion on behavioral inhibition in 8 to 12 years old boys with attention deficit hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54489</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention Deficit Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Twenty-five boys diagnosed with ADHD who had not received any psychotropic drugs for at least one month. After performing emotional stroop test and affective go no go, treatment with Ritalin (starting with 0.5 mg / kg in three divided doses and increasing the dose after 5 days to 1 mg / kg (2/3 doses in the morning and noon and 1/3 is given at 4 pm), starts in them and continues for 6 weeks, after 6 weeks the emotional stroop test and affective go no go are taken again. Intervention 2: Control group: 20 boys without any psychiatric disorders who perform emotional stroop test and affective go no go.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arghavan Fariborzifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 90, 3rd Floor, Kakh Building, Kakh Crossroads, 11th Mountain Alley, Head of Soroush Street, Ahmadabad Square, Isfahan City, Isfahan Province</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199653888</zip>
        <telephone>+98 31 3250 5466</telephone>
        <email>a.fariborzifar@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Tehranidoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry, School of Medicine Research Center for Cognitive and Behavioral Sciences, Roozbeh Hospital, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333715914</zip>
        <telephone>+98 21 5541 9151</telephone>
        <email>tehranid@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 8 to 12 years
History of not taking psychotropic drug in a recent month,
In the group of ADHD participants: Diagnosis of ADHD based on interview and history and K-SADS and Conners Parent Questionnaire, conducted by a psychiatrist</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>IQ based on Wechsler Intelligence Scale for Children (WISC) 4, below 70
In the group of participants Typical development: the presence of any psychiatric disorder or medical illness, which prevents them from participating in the test or causes changes in attention or mood changes in them, based on taking a history and interview and K-SADS and Conners Parent Questionnaire, performed by a psychiatrist
In the group of ADHD participants: the presence of other psychiatric disorders comorbid with ADHD (except oppositional defiant disorder) or the presence of any medical illness that prevents participants from participating in the test or causes a change in attention or mood changes in them
The child's unwillingness to participate in the study or the guardian's dissatisfaction with the child's participation in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Twenty-five boys diagnosed with ADHD who had not received any psychotropic drugs for at least one month. After performing emotional stroop test and affective go no go, treatment with Ritalin (starting with 0.5 mg / kg in three divided doses and increasing the dose after 5 days to 1 mg / kg (2/3 doses in the morning and noon and 1/3 is given at 4 pm), starts in them and continues for 6 weeks, after 6 weeks the emotional stroop test and affective go no go are taken again.</i_keyword>
      <i_keyword>Control group: 20 boys without any psychiatric disorders who perform emotional stroop test and affective go no go.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1.Mean reaction time in Affective go no go test. Timepoint: At the beginning of the study and 6 weeks after starting Ritalin in the ADHD group. Method of measurement: Affective go no go test computer software.</prim_outcome>
      <prim_outcome>2. Mean reaction time in emotional stroop test. Timepoint: At the beginning of the study and 6 weeks after starting Ritalin in the ADHD group. Method of measurement: Emotional stroop test computer software.</prim_outcome>
      <prim_outcome>3.Affective go/no go commission error. Timepoint: At the beginning of the study and 6 weeks after starting Ritalin in the ADHD group. Method of measurement: Affective go no go test computer software.</prim_outcome>
      <prim_outcome>4.Affective go/no go omission error. Timepoint: At the beginning of the study and 6 weeks after starting Ritalin in the ADHD group. Method of measurement: Affective go no go test computer software.</prim_outcome>
      <prim_outcome>5.Emotional stroop test commission error. Timepoint: At the beginning of the study and 6 weeks after starting Ritalin in the ADHD group. Method of measurement: Emotional stroop test computer software.</prim_outcome>
      <prim_outcome>6.Emotional Stroop test omission error. Timepoint: At the beginning of the study and 6 weeks after starting Ritalin in the ADHD group. Method of measurement: Emotional stroop test computer software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-19</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>13th floor, Block A, Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye_iran St, Ghods Town (West) - between South Falamak and Zarafshan, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
