<?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>IRCT20180125038507N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Study of therapeutic effects of Atomoxtein in reducing the symptoms of patients with recurrent vasovagal syncope</public_title>
      <acronym></acronym>
      <scientific_title>Study of the therapeutic effects of Atomoxetine in comparison with placebo on reducing the incidence of symptoms in patients with recurrent vasovagal syncope;</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32875</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomized and divided into two groups based on permutation blocks and they fall into one of the medication and placebo groups, Blinding description: This is a double-blind study. Both patients and investigators were blinded to the medication and placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Syncope.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Atomoxetine 20 mg daily, taken orally, for 2 weeks and  40 mg daily for another 2 weeks, if tolerated. The pills will be sealed in 2 envelopes for each 2-week period: 14 pills (20 mg) in envelope A and 14 pills (40 mg) in envelope B. Intervention 2: Control group: Placebo pills are administered orally daily for a period of 4 weeks in envelopes A and B as discussed earlier. Placebos will be produced by the pharmacy department of Tehran University of Medical Sciences.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data will be published

When:
2019

To whom:
All

Conditions:
All

Where to obtain:
Dr Masih Tajdini

How to obtain:
Appointment

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masih Tajdini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North kargar street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>+98 21 8802 9600</telephone>
        <email>drmasih84@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Bozorgi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>north kargar street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713138</zip>
        <telephone>+98 21 8802 9731</telephone>
        <email>saeedtofighi69@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who come to the Tehran Heart Center with a complaint of syncope or pre-syncope with the clinical diagnosis of vasovagal syncope or have undergone tilt test, if needed, and experienced at least 3 syncopal episodes in the past 3 months.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age under 10 or over 70 years old
History of uncontrolled blood pressure
History of structural heart disease
History of epilepsy
History of closed angle glaucoma
History of diabetes mellitus
History of coronary artery disease
Ejection fraction &lt; 50%
Use of monoamine oxidase inhibitors (MAOIs)
Use of selective serotonin reuptake inhibitors (SSRIs)
Use of anticonvulsants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R55</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Syncope and collapse</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: Atomoxetine 20 mg daily, taken orally, for 2 weeks and  40 mg daily for another 2 weeks, if tolerated. The pills will be sealed in 2 envelopes for each 2-week period: 14 pills (20 mg) in envelope A and 14 pills (40 mg) in envelope B.</i_keyword>
      <i_keyword>Control group: Placebo pills are administered orally daily for a period of 4 weeks in envelopes A and B as discussed earlier. Placebos will be produced by the pharmacy department of Tehran University of Medical Sciences.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of (pre-)syncopal episodes. Timepoint: Follow-up visit at month 1 and 3. Method of measurement: Based on history and physical exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Follow-up visit on month 3. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Follow-up visit on month 3. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.</sec_outcome>
      <sec_outcome>Physical quality of life. Timepoint: Follow-up visit on month 3. Method of measurement: 36-Item Short Form Survey Questionnaire.</sec_outcome>
      <sec_outcome>Mental quality of life. Timepoint: Follow-up visit on month 3. Method of measurement: 36-Item Short Form Survey Questionnaire.</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>2018-07-25</approval_date>
        <contact_name>School of Medicine- Tehran University of Medical Sciences</contact_name>
        <contact_address>North kargar street, Tehran heart center Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
