<?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>IRCT2017031121965N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-21</date_registration>
      <primary_sponsor>Vice chancellor for research, Guilan  University of Medical Sciences</primary_sponsor>
      <public_title>The effect of current stimulation and drug therapy on obsessive compulsive disorder</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparing Transcranial direct current stimulation with and without drug therapy on symptoms of patient with obsessive compulsive disorder: a Clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19079</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -.</study_design>
      <phase>3</phase>
      <hc_freetext>obsessive – compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. They will receive brain electrical stimulation (Transcranial direct current stimulation) while getting no medication. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation. Follow up visits will be one and three month later. Comparing to the other noninvasive stimulation, TDCS is a new and noninvasive brain electrical stimulation method that is safe, low cost and simply designed in order to use in outpatient settings. Intervention 2: Intervention Group 2: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. Treatment consists of sufficient dose of Serotonin reuptake inhibitors (SSRI), Fluoxetine 80 mg or Setraline 200 mg, daily in combination with brain electrical stimulation. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation. Follow up visits will be one and three month later. Comparing to the other noninvasive stimulation, TDCS is a new and noninvasive brain electrical stimulation method that is safe, low cost and simply designed in order to use in outpatient settings.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Kiomars Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>Kkiomars@yahoo.com</email>
        <affiliation>Guilan University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Kiomars Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa educational and remedial center, 15 Khordad avenue, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>Kkiomars@yahoo.com</email>
        <affiliation>Guilan University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with obsessive compulsive disorder; minimum score of 16 form YBOCS; aged between 18-55 years. Exclusion criteria: Antiepileptic drug therapy in the previous 6 months; neurologic disease; pregnancy; low intelligence quotient; head injury; any metallic instrument in brain or skull.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. They will receive brain electrical stimulation (Transcranial direct current stimulation) while getting no medication. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation. Follow up visits will be one and three month later. Comparing to the other noninvasive stimulation, TDCS is a new and noninvasive brain electrical stimulation method that is safe, low cost and simply designed in order to use in outpatient settings.</i_keyword>
      <i_keyword>Intervention Group 2: Twenty medical treatment - resistant patients suffering from obsessive compulsive disorders will be entered in this group. Treatment consists of sufficient dose of Serotonin reuptake inhibitors (SSRI), Fluoxetine 80 mg or Setraline 200 mg, daily in combination with brain electrical stimulation. Therapy will be carried out in four thirty-minute sessions with one-week interval between each two sessions and music will be played to calm the patients during electrical stimulation. Follow up visits will be one and three month later. Comparing to the other noninvasive stimulation, TDCS is a new and noninvasive brain electrical stimulation method that is safe, low cost and simply designed in order to use in outpatient settings</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive – compulsive disorder. Timepoint: Measured time intervals will be before the treatment and one and three months after the treatment. Method of measurement: Yale-Brown test.</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>Vice chancellor for research, Guilan  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-30</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research of Guilan University of Medical Sciences,  the upper floor of Iran Radiator Representation, in front of the Sepah bank, West Shahid Beheshti Blvd. Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
