<?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>IRCT20161103030680N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-02</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Citaloparam in migraine prophylaxsis</public_title>
      <acronym>citalopram and migraine</acronym>
      <scientific_title>Evaluation of citalopram efficacy in prevention of migraine headaches</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>226</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24298</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients referred to Mostafa  Khomeini neurology clinic who fulfilled criteria for study  at first are marked by a number an then assigned in two intervention and control groups alternatively by chart of random numbers. Selection of patient for first group is by lottery, Blinding description: All drugs and placebos are put in packages with the same shapes and dimensions and after code assignment the main researchers and students receive them. They are not aware of the package contents. Researchers are not aware of patients group. The study design is explained truly for each patient separately and notify that selection of group is randomly without their awareness.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Migraine headaches. Condition 2: Migraine headaches.</hc_freetext>
      <i_freetext>Intervention 1: patients in this group take Citalopram thirty milligrams at noon for two months. Dose escalation is gradually within two weeks. Intervention 2: Cotrol group: Patients take placebo which is provided with the same feature and weight at noon. Duration of treatment is two months.</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 certainty in ethical aspect from patient view.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Siamak Afshinmajd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entrance of Tehran -Qom express way, Shahed University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 3092</telephone>
        <email>safshinmajd@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siamak Afshinmajd</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Italia street, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643491</zip>
        <telephone>+98 21 8896 9438</telephone>
        <email>safshinmajd@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 45.
Suffering from migraine headaches according to international headache society criteria(IHS).
At least three attack of migraine in one month.
History of migraine for at least six months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from another type of headaches such as Cluster,Tension,.... .
History of Asthma, Renal and Heart failure, Depression, any allergic reaction to drugs used in study or similar drugs.
Patients who already take drugs for treatment for migraine.
History of using anti depressant, anti epileptics, Analgesics, Corticosteroids, Opium, Monoamine Oxidase, and Non steroidal anti inflammatory agents for other reasons.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G-43</hc_code>
      <hc_code>G43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine without aura (common migraine</hc_keyword>
      <hc_keyword>Migraine with aura (classic migraine)</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>patients in this group take Citalopram thirty milligrams at noon for two months. Dose escalation is gradually within two weeks.</i_keyword>
      <i_keyword>Cotrol group: Patients take placebo which is provided with the same feature and weight at noon. Duration of treatment is two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache Intensity. Timepoint: At the beginning and at the end of first and second month. Method of measurement: Visual Analougue Scale, And Six points behavioral rating scale BRS-6.</prim_outcome>
      <prim_outcome>Headache frequency. Timepoint: At the beginning and at the end of second month. Method of measurement: Number of attacks in one month.</prim_outcome>
      <prim_outcome>Headache duration. Timepoint: At the beginning and at the end of second month. Method of measurement: Average of headaches duration in hour.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug reactions such as skin redness, pruritus, burning sensation,. Timepoint: Immediately after patient alarm. Method of measurement: Observation and consultation with proper specialist.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-03-18</approval_date>
        <contact_name>Ethical committee of Shaded University</contact_name>
        <contact_address>Entrance of Tehran - Qom Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
