<?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>IRCT20221025056289N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-17</date_registration>
      <primary_sponsor>Alborz University of Medical Science</primary_sponsor>
      <public_title>the effect of citalopram on negative symptoms of schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of citalopram as an adjunctive therapy with olanzapine or aripiprazole on the improvement of negative symptoms in patients with chronic schizophrenia in placebo - randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66694</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual randomization will be performed using a four-block randomization scheme. The random sequence will be generated using STATA software and random numbers. In addition, to ensure randomization concealment, opaque, sealed envelopes will be used, which will be marked with a 5-digit random number sequence, Blinding description: In this study, the patients and the therapist will be blinded to the randomization assignment (double-blind).</study_design>
      <phase>3</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Under treatment with citalopram (up to 40 milligrams per day) and olanzapine (dose of 15 milligrams). Intervention 2: Intervention group: Under treatment with Citalopram (maximum of 40 milligrams per day) in addition to Aripiprazole (20 milligrams per day). Intervention 3: Control group: Under treatment with 15 milligrams per day of olanzapine accompanied by medication schedule. Intervention 4: Control group: Under treatment with Aripiprazole, 15 to 20 milligrams per day, accompanied by medication schedule.</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 The data won't be released until the publication of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeideh Mahmoudnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3185746957</zip>
        <telephone>+98 26 3340 1629</telephone>
        <email>mahmoudniasaeideh@gmail.com</email>
        <affiliation>Alborz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Zandifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3147734568</zip>
        <telephone>+98 26 3255 8920</telephone>
        <email>zandifaratefe@gmail.com</email>
        <affiliation>Alborz university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who, based on criteria, have been diagnosed with schizophrenia and are receiving treatment by a psychiatrist in a psychiatric ward up to 3 years after diagnosis.
The minimum PANSS score should be 60 in. This score requires a minimum of 20 on the negative symptom subscale and a BPRS score of 41.
The age range of participants is between 18 and 50.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The tendency and decision towards suicide in the Hamilton test.
The tendency and decision towards suicide in the Hamilton test.
Individuals with a score greater than 14 based on the 17-item Hamilton Depression Rating Scale (HDRS), or meeting major depression criteria, or having a score of above 4 on all but the depression item of the PANAS.
Patients diagnosed with any type of non-schizophrenic mental disorder, especially bipolar disorder, schizoaffective disorder, and individuals with major depressive disorders that have been identified by a psychiatric interview.
In addition, patients who have received electroconvulsive therapy (ECT) in the past 2 weeks are not eligible to participate in this study. Any serious or neurological medical condition, pregnancy or lactation, pregnant women without contraception, patients with Class IV and III heart failure, drug or insulin-dependent diabetes, liver disease, or congestive heart failure are not eligible for the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Under treatment with citalopram (up to 40 milligrams per day) and olanzapine (dose of 15 milligrams).</i_keyword>
      <i_keyword>Intervention group: Under treatment with Citalopram (maximum of 40 milligrams per day) in addition to Aripiprazole (20 milligrams per day).</i_keyword>
      <i_keyword>Control group: Under treatment with 15 milligrams per day of olanzapine accompanied by medication schedule.</i_keyword>
      <i_keyword>Control group: Under treatment with Aripiprazole, 15 to 20 milligrams per day, accompanied by medication schedule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative symptoms in patients with chronic schizophrenia. Timepoint: In this study, negative symptoms of schizophrenia will be assessed in the beginning, 4th week and at the end of the 8th week of the clinical trial. Method of measurement: The PANSS-BPRS questionnaire and the Hamilton questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Positive symptoms of patient with chronic schizophrenia. Timepoint: In this study, negative symptoms of schizophrenia will be assessed in the beginning, 4th week and at the end of the 8th week of the clinical trial. Method of measurement: Diagnosis based on DSM-5 criteria, PANSS-BPRS questionnaire.</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>Alborz University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-19</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
