<?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>IRCT20201026049155N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of repeated transcranial magnetic stimulation (RTMS) in reducing the percentage of suicidal ideation in depressed patients compared with the control group.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of repeated transcranial magnetic stimulation (rTMS) in reducing the percentage of suicidal ideation in depressed patients compared with the control group.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55397</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule. :Depending on the sample size and using the random allocation method, the letter A is written on 20 pieces of paper and the letter B is written on 20 pieces of paper and the papers are folded so that the letters A and B are not clear. The papers are poured into a container and mixed, and 
 by referring  to any depressed person with suicidal thoughts accidentally opens one of the folded papers.
if A:as a real magnetic stimulation and if B: was a placebo for patients, finally out of a sample of 40 people, 20 would randomly receive real magnetic stimulation and 20 would receive a placebo, Blinding description: On the day after hospitalization of a depressed patient with suicidal ideation in the hospital, Beck Depression and Suicide Questionnaires are completed by the researcher. The researcher does not know about the type of intervention that real rTms or placebo is performed. The patient is sent to the rTms room .In this case, one of the folded papers is opened randomly by the operator of the machine, and if it was A, 6 sessions of real magnetic stimulation, and if it was B, 6 sessions of placebo  is done for patients.
Patient selection is done randomly by the device operator. Patients and researchers do not know whether the magnetic stimulation is real or Placebo light is sent by the magnetic excitation operator, but the placement of the coil of the device is 90 degrees, which prevents the waves from reaching the skull.
The only person who knows the real thing or placebo is the device operator who writes the letter A or B in the relevant form next to the patient's name. Similarly, for 40 patients, the patient's name A or B will be registered in the relevant form. Finally, the completed form is given to the third person who analyzes the information. The researcher also gives the results of the questionnaires to this person who analyzes And there is no interference  in the questionnaires and statistical analysis.  After the statistical analysis is done, the intervention results are notified.
 Therefore, neither the researcher nor the patient is aware of the actual or placebo treatment and the study is double blind.</study_design>
      <phase>3</phase>
      <hc_freetext>1. Patients with major depression with suicidal ideation ,, 2. Patients with dysthymia with suicidal ideation ,, 3. Patients with double depression with suicidal ideation.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Depressed patients with suicidal ideation for 6 sessions are given as a placebo treatment of repeated transcranial magnetic stimulation with magstim device made in England.The statistical population of the study includes all depressed patients with suicidal ideation referred to Iran Psychiatric Hospital in Tehran in 2021. 40 eligible people will be selected according to the sampling method . 20patient  randomized receive placebo and 20 patient real transcranial magnetic stimulation (rTMS). )  . The duration of treatment will be 30 minutes and patients will receive 6 sessions of intervention. The method of work is as follows: At the beginning of admission to the ward or emergency department, the SCID questionnaire, Beck Suicide Thought Questionnaire and Beck Depression Inventory are completed.In addition to SSRI antidepressant drug therapy, patients are randomly selected for real rtms or placebo (forty patients, twenty placebo patients and twenty real rTMS patients) and rtms is started during the first week of hospitalization, which lasts for two consecutive days (morning, noon). Afternoon) real treatment or placebo rtms is doneAt the end of the first and second day, the Beck Suicide and Depression Inventory is completed again. Also, all patients are followed up one month after the start of treatment and the Beck Suicide and Depression Inventory is completed for them to determine the lasting effects of treatment. Intervention 2: Intervention group: Depressed patients with suicidal ideation for 6 sessions are given as a real treatment of repeated transcranial magnetic stimulation with magstim device made in England.The statistical population of the study includes all depressed patients with suicidal ideation referred to Iran Psychiatric Hospital in Tehran in 2021. 40 eligible people will be selected according to the sampling method . 20patient  randomized receive placebo and 20 patient real transcranial magnetic stimulation (rTMS). )  . The duration of treatment will be 30 minutes and patients will receive 6 sessions of intervention. The method of work is as follows: At the beginning of admission to the ward or emergency department, the SCID questionnaire, Beck Suicide Thought Questionnaire and Beck Depression Inventory are completed.In addition to SSRI antidepressant drug therapy, patients are randomly selected for real rtms or placebo (forty patients, twenty placebo patients and twenty real rTMS patients) and rtms is started during the first week of hospitalization, which lasts for two consecutive days (morning, noon). Afternoon) real treatment or placebo rtms is doneAt the end of the first and second day, the Beck Suicide and Depression Inventory is completed again. Also, all patients are followed up one month after the start of treatment and the Beck Suicide and Depression Inventory is completed for them to determine the lasting effects of treatment.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All HOPS data can be shared from unidentifiable individuals

When:
Access starts in july 2022

To whom:
There are no restrictions for applicants

Conditions:
Any research to help patients with psychiatric disorders is allowed

Where to obtain:
Iran,Tehran,8 km of Shahid Lashgari Highway, Iran Psychiatric Hospital, Dr. Seyed Mehdi Hosseini Contact number 00989125955223

How to obtain:
Correspondence or face-to-face referral to Iran Psychiatric Hospital, telephone or correspondence to e-mail address

Comments:
Thank you for your patience and I wish you the best days with health</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mehdi Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Psychiatric Hospital.km 8 Lashgari Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1398913151</zip>
        <telephone>+98 21 4450 3401</telephone>
        <email>dr.hoseini7252@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyd Mehdi Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Psychiatric Hospital.km8 Lashgari Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1398913151</zip>
        <telephone>+98 21 4450 3401</telephone>
        <email>dr.hoseini7252@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with major depression with suicidal ideation
Dysthymic patients with suicidal ideation
Patients with double depression with suicidal ideation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Metal objects in the skull
Pregnant lady
History of convulsions
Received an electric shock in a recent month
Psychotic depression
Postpartum Depression
Addiction
Mentally retarded
Borderline personality disorder
Dementia
Use of bupropion and methylphenidate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe depressive episode without psychotic symptoms,</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Depressed patients with suicidal ideation for 6 sessions are given as a placebo treatment of repeated transcranial magnetic stimulation with magstim device made in England.The statistical population of the study includes all depressed patients with suicidal ideation referred to Iran Psychiatric Hospital in Tehran in 2021. 40 eligible people will be selected according to the sampling method . 20patient  randomized receive placebo and 20 patient real transcranial magnetic stimulation (rTMS). )  . The duration of treatment will be 30 minutes and patients will receive 6 sessions of intervention. The method of work is as follows: At the beginning of admission to the ward or emergency department, the SCID questionnaire, Beck Suicide Thought Questionnaire and Beck Depression Inventory are completed.In addition to SSRI antidepressant drug therapy, patients are randomly selected for real rtms or placebo (forty patients, twenty placebo patients and twenty real rTMS patients) and rtms is started during the first week of hospitalization, which lasts for two consecutive days (morning, noon). Afternoon) real treatment or placebo rtms is doneAt the end of the first and second day, the Beck Suicide and Depression Inventory is completed again. Also, all patients are followed up one month after the start of treatment and the Beck Suicide and Depression Inventory is completed for them to determine the lasting effects of treatment.</i_keyword>
      <i_keyword>Intervention group: Depressed patients with suicidal ideation for 6 sessions are given as a real treatment of repeated transcranial magnetic stimulation with magstim device made in England.The statistical population of the study includes all depressed patients with suicidal ideation referred to Iran Psychiatric Hospital in Tehran in 2021. 40 eligible people will be selected according to the sampling method . 20patient  randomized receive placebo and 20 patient real transcranial magnetic stimulation (rTMS). )  . The duration of treatment will be 30 minutes and patients will receive 6 sessions of intervention. The method of work is as follows: At the beginning of admission to the ward or emergency department, the SCID questionnaire, Beck Suicide Thought Questionnaire and Beck Depression Inventory are completed.In addition to SSRI antidepressant drug therapy, patients are randomly selected for real rtms or placebo (forty patients, twenty placebo patients and twenty real rTMS patients) and rtms is started during the first week of hospitalization, which lasts for two consecutive days (morning, noon). Afternoon) real treatment or placebo rtms is doneAt the end of the first and second day, the Beck Suicide and Depression Inventory is completed again. Also, all patients are followed up one month after the start of treatment and the Beck Suicide and Depression Inventory is completed for them to determine the lasting effects of treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease in Suicidal Score in Beck questionnaire. Timepoint: Before the intervention and after the third and sixth sessions and one month after intervention. Method of measurement: Beck Suicide 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>Vice Chancellor for Research, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-29</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran Psychiatric  Hospital; Km 8 Lashgari Bivd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
