<?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>IRCT20110802007202N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Methylphenidate and atomoxetine in attention deficit hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of methylphenidate and atomoxetine in the treatment of attention deficit hyperactivity disorder in adult patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7635</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For designating patients in 2 groups, blocked randomization method is used. The unit of randomization is individual-based and due to the sample size of 36, eighteen of 2-unit blocks are generated. In order to determine the random sequence, “Coin Flip” method is used for assigning the first patient in each block. The first patient is placed in group A if the “head” side is seen as the result of the coin flip and if otherwise, the “tail” is seen, the patient is placed in group B. To generate the random sequence, this process is repeated for next set of blocks until the final patient is designated to the assigned group.
To conceal the randomized allocation, the sequentially numbered, opaque sealed envelopes (SNOSE method) is used.
36 opaque numbered envelopes are provided, then each of the sequences is recorded on a card and inserted in an envelope. Finally, the envelopes are placed in a box. At the time of participation of each patient in the trial, the first envelope is opened and the patient 's group is revealed.
The random allocation process is done by the hospital pharmacist who does not participate in the study, Blinding description: It is impossible to blind the physician, patient and data coordinator who is the researcher in this study due to the kind of disease and the medicines.
This study is single blinded and the analyzer is unaware of the kind of the medicines given to the patients. The data gathered during the study of patients by the researcher is then unknowingly given to the analyzer and statistics expert.</study_design>
      <phase>3</phase>
      <hc_freetext>Attention deficit hyperactivity disorder in adults.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Pharmacotherapy with methylphenidate 10 milligram immediate release tablets ( Ritalin) manufactured by Novartis pharmaceutical industry in Switzerland. The medicine's dosage is determined by psychotherapist but routinely it starts with 5 milligrams three times daily for one week and then it is increased to 10 milligrams three times daily. ( Based on the medicine's effectiveness and adverse effects, the dose can be increased up to 1.2 milligrams per body weight  kilograms per day.). Intervention 2: Intervention group 2: Pharmacotherapy with atomoxetine capsules (Stramox) manufactured by Tadbire kalaye jam pharmaceutical industry in Iran. The medicine's dosage is determined by psychotherapist but routinely it starts with 10 milligrams daily for the first week and then the dose is increased to 20 milligrams for the next two weeks and finally to 40 milligrams per day. (Based on the medicine's effectiveness and adverse effects, the dose can be increased up to 1.2 milligrams per body weight kilograms per day.).</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 There is no more information provided.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parya Tajmehrabi Namini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.30 ,Abbasi alley, Besat st, Fatemi st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419644551</zip>
        <telephone>+98 21 6693 3989</telephone>
        <email>paryataj@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Padideh Ghaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 5541 4540</telephone>
        <email>pghaeli@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>Attention Deficit Hyperactivity Disorder
Age between 19-50 years
Signing consent form</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of any systemic disorder such as cardiovascular diseases
Patients with a history of bipolar disorder, major depressive disorder, psychosis, substance abuse, pervasive developmental disorder and intellectual disability
Using psychotropic drugs within one month prior to the initiation of the study</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Pharmacotherapy with methylphenidate 10 milligram immediate release tablets ( Ritalin) manufactured by Novartis pharmaceutical industry in Switzerland. The medicine's dosage is determined by psychotherapist but routinely it starts with 5 milligrams three times daily for one week and then it is increased to 10 milligrams three times daily. ( Based on the medicine's effectiveness and adverse effects, the dose can be increased up to 1.2 milligrams per body weight  kilograms per day.)</i_keyword>
      <i_keyword>Intervention group 2: Pharmacotherapy with atomoxetine capsules (Stramox) manufactured by Tadbire kalaye jam pharmaceutical industry in Iran. The medicine's dosage is determined by psychotherapist but routinely it starts with 10 milligrams daily for the first week and then the dose is increased to 20 milligrams for the next two weeks and finally to 40 milligrams per day. (Based on the medicine's effectiveness and adverse effects, the dose can be increased up to 1.2 milligrams per body weight kilograms per day.)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of inattentive and hyperactive symptoms in Conners Adult ADHD Rating Scale - self report questionnaire. Timepoint: Before intervention and 2, 4, 6 and 8 weeks after the intervention. Method of measurement: Self report Conners Adult ADHD Rating Scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The score of Hamilton Depression questionnaire. Timepoint: Before intervention and 8 weeks after the intervention. Method of measurement: Hamilton depression questionnaire.</sec_outcome>
      <sec_outcome>The score of  Hamilton Anxiety questionnaire. Timepoint: Before intervention and 8 weeks after the intervention. Method of measurement: Hamilton Anxiety questionnaire.</sec_outcome>
      <sec_outcome>The score of general assessment of functioning scale. Timepoint: Before intervention and 8 weeks after the intervention. Method of measurement: General assessment of functioning scale.</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>2017-12-02</approval_date>
        <contact_name>Ethics committee of Pharmaceutical Sciences Research Center of Tehran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Pharmacy, Tehran University of Medical Sciences, 16th Azar Street., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
