<?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>IRCT20160530028182N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-15</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Aripiprazle in ADHD and ODD</public_title>
      <acronym></acronym>
      <scientific_title>The effect of betahistine on hyperactivity disorder in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual based-simple randomization, Blinding description: The drug is prepared by the pharmacist and in coding packages which only the pharmacist is aware of its coding and deliverd by researcher to the patient. Neither the investigator, nor the patient nor the analyst, knows the contents of the drug packages and the way they are coded.</study_design>
      <phase>3</phase>
      <hc_freetext>Attention deficit/hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the research consisted of 76 participants who were randomly assigned to receive intervention and control group. Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one o'clock 14) and in the case of a weight of over 30 kilograms, from the second week, 3 tablets (one and a half hours at 8 o'clock, one and half hours at 14 o'clock) are prescribed daily. The dosage is 8 mg per day for the first week of the week (half a tablet at 8:00 and half a tablet at 14) and from the second week, 2 tablets (one morning at 8, one hour at 14). Intervention 2: Control group:  Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one o'clock 14) and in the case of a weight of over 30 kilograms, from the second week, 3 tablets (one and a half hours at 8 o'clock, one and half hours at 14 o'clock) are prescribed daily. herapeutic dosage of placebo is prescribed a tablet daily for the first week ( one cap in the morning at 8 o'clock) and 2 cap are daily prescribed in the second week (one cap in the morning at 8 o'clock, one cap at 16 o'clock).</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 No more information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soleiman Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66614713446</zip>
        <telephone>+98 87 3366 4653</telephone>
        <email>dr.mohammadzadeh86@muk.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Soleiman Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street</address>
        <city>sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66614713446</zip>
        <telephone>+98 87 3366 4653</telephone>
        <email>dr.mohammadzadeh86@muk.ac.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 8-18 years
Diagnosis of ADHD and ODD based on DSM5 without effective medication
Taking on mental status at least 2 weeks before the study</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Intelectual disability based on clinical suspicious
Presence of uncontroled siezure
Drug side effects and hypersensivity
Recieving of any other drugs
History of psychological disorder except for ADHD and ODD 
Presence of medical diseases such as cardiac diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention deficit/hyperactivity disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the research consisted of 76 participants who were randomly assigned to receive intervention and control group. Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one o'clock 14) and in the case of a weight of over 30 kilograms, from the second week, 3 tablets (one and a half hours at 8 o'clock, one and half hours at 14 o'clock) are prescribed daily. The dosage is 8 mg per day for the first week of the week (half a tablet at 8:00 and half a tablet at 14) and from the second week, 2 tablets (one morning at 8, one hour at 14)</i_keyword>
      <i_keyword>Control group:  Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one o'clock 14) and in the case of a weight of over 30 kilograms, from the second week, 3 tablets (one and a half hours at 8 o'clock, one and half hours at 14 o'clock) are prescribed daily. herapeutic dosage of placebo is prescribed a tablet daily for the first week ( one cap in the morning at 8 o'clock) and 2 cap are daily prescribed in the second week (one cap in the morning at 8 o'clock, one cap at 16 o'clock).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvment in Attention-deficit symptoms. Timepoint: Baselin, second, fourth and eighth weeks after intervention. Method of measurement: Canner's and ADHD Rating scales.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of ADHD symptoms. Timepoint: Baselin, second, fourth and eighth weeks after intervention. Method of measurement: ADHD Rating scale and CGI.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-13</approval_date>
        <contact_name>Kurdestan University of Medical Sciences</contact_name>
        <contact_address>Pasdaran street Sanandaj ُSanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
