<?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>IRCT20200825048515N58</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-05</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of therapeutic effects of adding memantine to stimulants in children with attention deficit hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of therapeutic effects of adding memantine to stimulants in children with attention deficit hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65611</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method is permuted block randomization. In this way, first using online software (sealed envelope), a sequence of random numbers will be created and by the same software, the generated numbers will be divided into 40 blocks of 2. An equal number in each block will be 1 item from the intervention group and 1 item from the control group. So by doing each block, 2 patients (equally) will be assigned to each group, Blinding description: In this study, two drugs, memantine, and placebo are pre-prepared by the pharmacist in the same shape and color, placed in coded packages, and delivered to the researcher. She prescribes them without knowing the type of each drug.
Also, the patients, the investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Attention-deficit hyperactivity disorder (ADHD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group receive their routine treatment. In addition, they will be treated with memantine. The prescribed dose in children is based on weight, so that for children weighing more than 60 kg, the maximum dose is 15 mg/day, and for children weighing 39 to 60 kg, the maximum dose is 9 mg/day, and for children weighing 20 to 39 kg, the maximum dose is 6 mg/day and with a weight of less than 20 kg, a maximum dose of 3 mg/day is prescribed. The duration of the study will be one month after stabilizing the dose of memantine based on weight or the maximum dose tolerated by the patient. Intervention 2: Control group: patients in this group receive their routine treatment. In addition, they will be prescribed the same as the placebo intervention group.</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>Farnaz Golmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry; Imam Hossein (S) Hospital; Imam Khomeini street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195163381</zip>
        <telephone>+98 31 3386 6266</telephone>
        <email>Farnazgolmohammadi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Golmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry; Imam Hossein (S) Hospital; Imam Khomeini street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8195163381</zip>
        <telephone>+98 31 3386 6266</telephone>
        <email>Farnazgolmohammadi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with attention deficit hyperactivity disorder (ADHD)
Age range 6 to 12 years
Treated with methylphenidate
Parents' consent to participate in the study</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having major medical disorders (diabetes, asthma, heart disease, seizures)
Having a concomitant psychiatric disorder (mood and anxiety disorders and behavioral and confrontational disorders - disobedience)
Taking another drug in addition to a long-acting stimulant
Mental retardation
Drug sensitivity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, unspecified type</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: Patients in this group receive their routine treatment. In addition, they will be treated with memantine. The prescribed dose in children is based on weight, so that for children weighing more than 60 kg, the maximum dose is 15 mg/day, and for children weighing 39 to 60 kg, the maximum dose is 9 mg/day, and for children weighing 20 to 39 kg, the maximum dose is 6 mg/day and with a weight of less than 20 kg, a maximum dose of 3 mg/day is prescribed. The duration of the study will be one month after stabilizing the dose of memantine based on weight or the maximum dose tolerated by the patient.</i_keyword>
      <i_keyword>Control group: patients in this group receive their routine treatment. In addition, they will be prescribed the same as the placebo intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive Problems. Timepoint: Before and after the intervention. Method of measurement: The Conners' Parent Rating Scale (CPRS).</prim_outcome>
      <prim_outcome>Social problems. Timepoint: Before and after the intervention. Method of measurement: The Conners' Parent Rating Scale (CPRS).</prim_outcome>
      <prim_outcome>Psychosomatic problems. Timepoint: Before and after the intervention. Method of measurement: The Conners' Parent Rating Scale (CPRS).</prim_outcome>
      <prim_outcome>Anxiety-shyness. Timepoint: Before and after the intervention. Method of measurement: The Conners' Parent Rating Scale (CPRS).</prim_outcome>
      <prim_outcome>Inhibitory control. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</prim_outcome>
      <prim_outcome>Emotional modulation. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</prim_outcome>
      <prim_outcome>Ability to shift set. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</prim_outcome>
      <prim_outcome>Initiating. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</prim_outcome>
      <prim_outcome>Planning. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</prim_outcome>
      <prim_outcome>Organizing. Timepoint: Before and after the intervention. Method of measurement: BREIF scale.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-12</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
