<?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>IRCT20180704040344N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-05</date_registration>
      <primary_sponsor>Deputy of Research _ Azarbaijan Shahid Madani University</primary_sponsor>
      <public_title>Effect of Transcranial direct-current stimulation on cognitive biases and coherence pattern of cortex</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Transcranial direct-current stimulation on improvement of cognitive biases and coherence pattern of cortex in patients with major depression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Of patients with major depression in Tabriz, 30 patients were selected using Purposive sampling. Then, 10 patients in the experimental group, 10 patients in the sham group (placebo) and 10 patients in the control group were randomly (Using random numbers table) selected, Blinding description: In this study, there are three groups of experimental, sham (placebo) and control groups that the placebo group is not aware of because they are in the placebo group (sham) and are not being treated; because it is known whether the effect of the intervention is solely due to Therapeutic tool (tDCS) or the induction of placebo has also been effective in the treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major Depression Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: tDCS was applied with an anodic electrode in the left DLPFC region and a cathode electrode in the right DLPFC region for 10 continuous days, with direct electric current, at 2 mA with a duration of 20 minutes per session. Intervention 2: Placebo group: tDCS electrodes were placed on the head for 10 consecutive sessions and with a duration of 20 minutes, but the device was turned off and not stimulated.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Arabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Alley Sajjad, Imam Reza street19, Imam Reza Blvd</address>
        <city>Daregaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9491835319</zip>
        <telephone>+98 51 4622 7853</telephone>
        <email>ali.arabi1992.1370@gmail.com</email>
        <affiliation>Azarbaijan Shahid Madani University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Arabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Alley Sajjad, Imam Reza street19, Imam Reza Blvd</address>
        <city>Daregaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9491835319</zip>
        <telephone>+98 51 4622 7853</telephone>
        <email>ali.arabi1992.1370@gmail.com</email>
        <affiliation>Azarbaijan Shahid Madani University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 40 years, having Major Depression Disorder Based on DSM5 Criteria, Minimum education middle school, dextrality.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having psychotic diseases and coincidence with other disorders, Concurrent use of drug, Concurrent use of medicine, and The subject's dissatisfaction of Continue to collaborate.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: tDCS was applied with an anodic electrode in the left DLPFC region and a cathode electrode in the right DLPFC region for 10 continuous days, with direct electric current, at 2 mA with a duration of 20 minutes per session.</i_keyword>
      <i_keyword>Placebo group: tDCS electrodes were placed on the head for 10 consecutive sessions and with a duration of 20 minutes, but the device was turned off and not stimulated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement of Cognitive biases due to Depression. Timepoint: Before applying tDCS and 10 sessions after applying tDCS. Method of measurement: Cognitive tests of Eriksen Folanker and Corsi block-tapping.</prim_outcome>
      <prim_outcome>Improvement of Cortical Coherence Pattern interhemispheric and intrahemispheric between different parts of the brain in differen bands of electrical activity. Timepoint: Before applying tDCS and 10 sessions after applying tDCS. Method of measurement: Electroencephalography(EEG).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improvement of Depression. Timepoint: Before applying tDCS and 10 sessions after applying tDCS. Method of measurement: Beck Depression Inventory.</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>Deputy of Research _ Azarbaijan Shahid Madani University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-31</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Third floor, Central building number 2, Tabriz University of Medical Sciences, Golgasht Street. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
