<?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>IRCT20090801002266N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-31</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>َAntidepressant effect of ketamine</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of anti-depressant effect of oral ketamine, intramuscular ketamine and electroconvulsive therapy in the patients with major depressive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study the patients divides into three 15 individual groups which receive electro convulsive therapy, 1mg/kg oral ketamine and 0.5 mg/kg intramuscular ketamine through 3 weeks in 6-9 sessions. the 17 items Hamilton depression scale(17-HDS) and beck scale for suicidal ideation (BSSI) will be assessed and compared between groups in specific intervals and one month after last intervention. also the satisfaction of each group will be assessed with a questionnaire  and compared between groups, Randomization description: The selected 45 cases in this study, will be divided in three intervention groups as block randomization, with sealed envelops numbered 1 to 45 in which there is an intervention method, that is randomly selected with computer software.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Major depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: intra muscular ketamine, NMDA antagonist, 0.5mg/kg dosage, 500 mg vial, rotex medica factory in Germany, 6-9 injection through 3weeks. Intervention 2: Second intervention group: intra muscular ketamine, NMDA antagonist, 1mg/kg dosage, 500 mg vial, rotex medica factory in Germany, 6-9 prescription through 3 weeks in which the injectable ketamine will be added to juice and will be taken orally. Intervention 3: Third intervention group: the bilateral electroconvulsive therapy group that begin with 25mC after short anesthesia in 6-9 sessions through three weeks.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Kheirabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behavioal science research center, noor hospital, ostandari street, isfahan, iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145831451</zip>
        <telephone>+98 31 3222 2135</telephone>
        <email>kheirabadi@bsrc.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Kheirabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behavioral sciences research center, Noor hospital, Ostandari Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145831451</zip>
        <telephone>+98 31 3222 2135</telephone>
        <email>kheirabadi@bsrc.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Major depressive patients based on DSM 5 criteria candidate  for electro convulsive therapy
Age between 18-70 years old
Informed consent form obtained</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug side effects which discontinuation is necessary
Patient`s disagreement to stay in study
Deterioration of patient`s symptoms
Not to respond after 4 intervention sessions.
Drug sensitivity
Severe or active hepatic renal cardiac urological disease
Substance abuse
Previous manic or hypo manic episode
Catatonia
Secondary depression due to another medical conditions
History of psychosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent severe without psychotic features</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: intra muscular ketamine, NMDA antagonist, 0.5mg/kg dosage, 500 mg vial, rotex medica factory in Germany, 6-9 injection through 3weeks</i_keyword>
      <i_keyword>Second intervention group: intra muscular ketamine, NMDA antagonist, 1mg/kg dosage, 500 mg vial, rotex medica factory in Germany, 6-9 prescription through 3 weeks in which the injectable ketamine will be added to juice and will be taken orally.</i_keyword>
      <i_keyword>Third intervention group: the bilateral electroconvulsive therapy group that begin with 25mC after short anesthesia in 6-9 sessions through three weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in hamilton depression scale. Timepoint: Before intervention, 24 hours, one week, two weeks, three weeks, four weeks and eight weeks after begining the intervention. Method of measurement: Hamilton depression scale-17 items.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Suicidal scores in beck scale for suicidal ideation. Timepoint: Before intervention, 24 hours, one week, two weeks, three weeks, four weeks and eight weeks after begining the intervention. Method of measurement: Beck scale for sicidal ideation.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-21</approval_date>
        <contact_name>Ethics commitee of isfahan university of medical science</contact_name>
        <contact_address>Behavioal science research center, Noor hospital, Ostandari street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
