<?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>IRCT20211121053132N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-11</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of ketamine with midazolam on suicidal ideation in suicide attempters</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effects of ketamine with midazolam on reducing suicidal ideation in suicide attempters undergoing intubation treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82726</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling method: Patients are selected consecutively.
The first two people who meet the conditions for entering the sample are selected and form a block, and these blocks continue until the sample size is reached. (We will conduct a trial for both people in the manner that will be mentioned and record all the steps and results of the questionnaire, so the purpose of reaching the sample size is not in one day but in a period of time that depends on the number of clients and hospitalized patients.) Within these blocks, people are randomly assigned to either the first intervention or the second intervention, which is done using a random number table. If the number is from 0 to 4, the first person receives the first drug, and otherwise (5-9) the second person. These people are sorted within the block by national code and become the first and second patients. (The larger 10-digit number is the first patient and the smaller number is the second patient), Blinding description: The two study medications, which were randomly assigned to the patients forming each block using a random number table, are placed in fully sealed envelopes. The participant number in the study (from 1 to 42), corresponding to the medication, is written on the envelope. An experienced nurse who is not a member of the study team, and therefore has no conflict of interest, is selected and instructed to prepare the medication for injection in a separate room out of sight of the researchers and study participants. (Since the nurse administering the injection is not a member of the study team, the name or code of the medication is written on the envelope for the nurse’s information). 
Since the patient is under anesthesia and unaware of the medication they receive, and the study investigator (a psychiatrist who is the primary designer of the research question and potentially exposed to conflicts of interest) is also unaware of which medication each patient receives, blinding has been implemented.
Blinding was not applied to the person responsible for data collection, the outcome assessor, and the statistical consultant.
It is noteworthy that informed consent was obtained from the patient’s guardian or legal supervisor prior to participation, and after the patient regains consciousness, they will be informed about their participation in the study—though they will not be informed of the specific medication they received.</study_design>
      <phase>3</phase>
      <hc_freetext>Suicidal thoughts.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intubated suicide attempters will receive intravenous racemic ketamine hydrochloride from Exir Company at a dose of 0.5 mg/kg in 100 cc of normal saline, infused over 45 minutes. Intervention 2: Control group: Intubated suicide attempters will receive intravenous midazolam from Exir Company at a dose of 0.3 to 0.5 mg/kg in 100 cc of normal saline, infused over 40 minutes.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azade Erfan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>‏Department of Psychiatry, Nour Center, Khurshid Hospital, Ostandari Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145833117</zip>
        <telephone>+98 31 3222 2475</telephone>
        <email>Azade.erfan@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azade Erfan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>‏Department of Psychiatry, Nour Center, Khurshid Hospital, Ostandari Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145833117</zip>
        <telephone>+98 31 3222 2475</telephone>
        <email>Azade.erfan97@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients between 18 to 65 years, who were admitted to the intensive care unit of Khorshid Hospital due to suicide
Consent from the guardian or legal supervisor</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>ECG with extensive abnormal changes
History of ketamine abuse or dependence</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R45.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other symptoms and signs involving emotional state</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>Intervention group: Intubated suicide attempters will receive intravenous racemic ketamine hydrochloride from Exir Company at a dose of 0.5 mg/kg in 100 cc of normal saline, infused over 45 minutes.</i_keyword>
      <i_keyword>Control group: Intubated suicide attempters will receive intravenous midazolam from Exir Company at a dose of 0.3 to 0.5 mg/kg in 100 cc of normal saline, infused over 40 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Suicidal ideation score on the Beck-21 Suicidal Ideation Questionnaire scale. Timepoint: After patients are fully conscious (about 24 to 48 hours after receiving the medication). Method of measurement: Beck-21 Suicidal Ideation Questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-31</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences</contact_name>
        <contact_address>Research Ethics Committees of School of Medicine , Isfahan University of Medical Sciences , Hezar Jarib Ave, Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
