<?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>IRCT20200304046698N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-09</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effects of escitalopram and Citalopram on Depression in Patients with Chronic Kidney Failure under Hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of the effects and complications of escitalopram and citalopram on depression in patients with chronic renal failure undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a prospective, double-blind, randomized clinical trial. Patients according to the table of random numbers were assigned to receive either escitalopram or citalopram for 6 weeks, Blinding description: Patients participating in the design and principal investigator were kept blind to the assigned study groups.As the drugs were selected from a single drug company and in order to double-blind the study, the escitalopram and citalopram tablets were provided by the pharmacist in a completely similar capsules form drug to the patients and distributed to the patients based on the treatment group and with a confidential code.</study_design>
      <phase>3</phase>
      <hc_freetext>Major depressive disorder, chronic renal failure.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: In this group escitalopram is  prescribed .escitalopram dose increased from 5 mg to 10 mg per day. The drugs were selected from Tehran Pharmaceutical Company and in order to double blind study,escitalopram tablets were provided by a pharmacist in capsule form and distributed to patients based on group therapy and confidential code.  Patients' follow-up was performed after 6 weeks of treatment and after completing the course of re-treatment, Hamilton test was examined and drug side effects including: dry mouth, nausea, yawning, sweating, agitation, reduction Appetite, constipation, diarrhea, drowsiness, headache and sexual problems, According to the questionnaire was prepared by the researcher was measured. Intervention 2: The control group: In this group citalopram prescribed.The dose of the drug was increased from 10 mg to 20 mg per day.The drugs were selected from the drug company Poursina and in order to double blind study,citalopram tablets were provided by a pharmacist in capsule form and distributed to patients based on group therapy and confidential code.Patients' follow-up was performed after 6 weeks of treatment and after completing the course of re-treatment, Hamilton's test was examined and drug side effects including: dry mouth, nausea, yawning, sweating, agitation, reduction Appetite, constipation, diarrhea, drowsiness, headache and sexual problems, According to the questionnaire was prepared by the researcher was measured.</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>mina ayatollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 50, Ershad eslami St., Safaiieh</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916864651</zip>
        <telephone>+98 35 3824 0667</telephone>
        <email>mina_6432@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mina ayatolahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 50, Ershad eslami St., Safaiieh</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916864651</zip>
        <telephone>+98 35 3824 0667</telephone>
        <email>mina_6432@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with major depressive disorder with minimum depression score of 13 with Hamilton Test and psychiatrist approval
Patients with renal failure who have been undergoing hemodialysis treatment for at least 3 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic medical disease (heart disease, diabetes, epilepsy, hypertension, thyroid) that interferes with medication use or follow-up.
Liver failure, Hepatitis B and C, HIV / AIDS
Existence of psychiatric disorder other than depression
Patient being treated with SSRIs (if previously treated after 3 months treatment)
Pregnancy or lactation
Addiction to all kinds of drugs and psychotropics
The occurrence of any unbearable side effects in the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persistent mood [affective] disorders</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>The intervention group: In this group escitalopram is  prescribed .escitalopram dose increased from 5 mg to 10 mg per day. The drugs were selected from Tehran Pharmaceutical Company and in order to double blind study,escitalopram tablets were provided by a pharmacist in capsule form and distributed to patients based on group therapy and confidential code.  Patients' follow-up was performed after 6 weeks of treatment and after completing the course of re-treatment, Hamilton test was examined and drug side effects including: dry mouth, nausea, yawning, sweating, agitation, reduction Appetite, constipation, diarrhea, drowsiness, headache and sexual problems, According to the questionnaire was prepared by the researcher was measured.</i_keyword>
      <i_keyword>The control group: In this group citalopram prescribed.The dose of the drug was increased from 10 mg to 20 mg per day.The drugs were selected from the drug company Poursina and in order to double blind study,citalopram tablets were provided by a pharmacist in capsule form and distributed to patients based on group therapy and confidential code.Patients' follow-up was performed after 6 weeks of treatment and after completing the course of re-treatment, Hamilton's test was examined and drug side effects including: dry mouth, nausea, yawning, sweating, agitation, reduction Appetite, constipation, diarrhea, drowsiness, headache and sexual problems, According to the questionnaire was prepared by the researcher was measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score  on the Hamilton scale. Timepoint: Assessment of Hamilton depression score at baseline and 6 weeks after intervention. Method of measurement: Hamilton Depression Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effect. Timepoint: At baseline (before intervention) and 6 weeks after drug administration. Method of measurement: Questionnaire designed by the researcher.</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>Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-25</approval_date>
        <contact_name>IR.SSU.MEDICINE.REC</contact_name>
        <contact_address>No. 50, molasadra, ershad eslami street, yazs Town, yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
