<?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>IRCT20140825018927N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of brainwave indices in overactive children receiving automoxetine and ritalin</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>Comparison of QEEG(Quantitaive electroencephalography) indices in children with ADHD (Attention deficit hyperactivity disorder)in two groups receiving automoxetine and ritalin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Children7-12 years old with ADHD diagnosed according to DSM-5 criteria and adolescent psychiatrist enter clinical trial after obtaining informed consent from parents about their children's participation in the study and inclusion criteria, Randomization description: Patients are randomly assigned to either the Ritalin and the automoxetin treatment groups according to the National Code Number of Participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>بیش فعالی - نقص توجه.</hc_freetext>
      <i_freetext>Intervention 1: Children with ADHD, aged 7-12 years, enter the study after obtaining informed consent from parental clinical trial studies and having inclusion and exclusion criteria. Parents' Connors Test is used to determine the severity of the disease.The brain wave markers are recorded  for sever disorderes with LORETA QEEG, then the drug treatment with automoxetine at a dose of 0.5-1.8 mg daily is continued for 3 months, then the QEEG is recorded. Intervention 2: Intervention group2: Children with ADHD, aged 7-12 years, enter the study after obtaining informed consent from parental clinical trial studies and having inclusion and exclusion criteria. Parents' Connors Test is used to determine the severity of the disease.The brain wave markers are recorded  for sever disorderes with LPRETA QEEG, then the drug treatment with Ritalin at a dose of 0.3-1 mg daily is continued for 3 months, then the QEEG is recorded.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is در ابتدای مطالعه هستم</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sahar salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical psychiatric research center, Razi educational-medical center, Eil goli street, Tabriz, Eastern Azarbayjan, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5465433452</zip>
        <telephone>+98 41 3383 1269</telephone>
        <email>sahar65salimi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Gholamreza Noorazar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical psychiatric research center, Razi educational-medical center, Eil goli street, Tabriz, Eastern Azarbayjan, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5644532341</zip>
        <telephone>+98 41 3383 1269</telephone>
        <email>s.gh.noorazar@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>7-12 years old
Male gender
Parental consent for child participation in research
IQ greater than 70
Diagnosis of ADHD by a child and adolescent psychiatrist</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of medication for ADHD
Other psychiatric disorders
Existence of medical diseases</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Children with ADHD, aged 7-12 years, enter the study after obtaining informed consent from parental clinical trial studies and having inclusion and exclusion criteria. Parents' Connors Test is used to determine the severity of the disease.The brain wave markers are recorded  for sever disorderes with LORETA QEEG, then the drug treatment with automoxetine at a dose of 0.5-1.8 mg daily is continued for 3 months, then the QEEG is recorded.</i_keyword>
      <i_keyword>Intervention group2: Children with ADHD, aged 7-12 years, enter the study after obtaining informed consent from parental clinical trial studies and having inclusion and exclusion criteria. Parents' Connors Test is used to determine the severity of the disease.The brain wave markers are recorded  for sever disorderes with LPRETA QEEG, then the drug treatment with Ritalin at a dose of 0.3-1 mg daily is continued for 3 months, then the QEEG is recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Brainwave indices. Timepoint: At baseline, 3 months later. Method of measurement: Quantitative electroencephalography ( Qualitative brainwave recorder,LORETA).</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-11</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central campus of Tabriz university of medical science, Golgasht Avenue, Azadi street, Tabriz, Eastern Azarbayjan, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
