<?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>IRCT2014041317246N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-23</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology Development-Ahwaz  Jondishapur University of Medical Sci</primary_sponsor>
      <public_title>The Effect of Sertraline In Treatment Of Schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Typical Antipsychotic Augmentation with Sertraline in Reduction of Negative Symptoms in patients with Schizophrenia in Ahwaz Golestan Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15907</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Sertraline, tab 50 mg, oral, once a day, for 6 weeks. Intervention 2: Placebo, tab 50 mg, oral, once a day, for 6 weeeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Seyed Moammad Seyed Ghafari Dezfuli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6481958956</zip>
        <telephone>+98 61 1336 7543</telephone>
        <email>raz.s@ajums.ac.ir</email>
        <affiliation>Ahwaz Jondishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh  Raz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6481958956</zip>
        <telephone>+98 61 1336 7543</telephone>
        <email>raz.s@ajums.ac.ir</email>
        <affiliation>Ahwaz Jondishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for this study are as follows: schizophrenia - a negative score more than 15 in PANSS; no liver disease; not treated with ECT in the past six months; during illness for over one year; aged between 21 to 63 years old.&#13;
The Exclusion criteria are: depression; mental retardation; schizoaffective disorder; bipolar disorder;  a neurological disorder such as epilepsy, Parkinson's disease; a risky physical illness such as cardiac ischemia or heart failure; use of antidepressants or lithium for whatever reason; Leisure drug; drug abuse within one recent month (except nicotine and caffeine); extrapyramidal side effects; deafness or dumbness active suicidal  or homicidal thoughts; pregnant or lactating women; at least 3 months have passed since the last time the use of long-acting antipsychotics; drugs with a history of hypersensitivity or serious interest in the study; the patient withdrew from the study and side effects.</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>63 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Sertraline, tab 50 mg, oral, once a day, for 6 weeks</i_keyword>
      <i_keyword>Placebo, tab 50 mg, oral, once a day, for 6 weeeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional withdrawal. Timepoint: Before intervention,1 week after intervention, 3 weeks after intervention, 6 weeks after intervention. Method of measurement: PANSS(Positive and Negative Symptom Scale).</prim_outcome>
      <prim_outcome>Social withdrawal. Timepoint: Before  intervention, 1 week after intervention, 3 weeks after intervention, 6 weeks after intervention. Method of measurement: PANSS(Positive and Negative Symptom Scale).</prim_outcome>
      <prim_outcome>Blunted affect. Timepoint: Before intervention,1 week after intervention, 3 weeks after intervention, 6 weeks after intervention. Method of measurement: PANSS(Positive and Negative Symptom Scale).</prim_outcome>
      <prim_outcome>Other negative symptoms. Timepoint: Before intervevtion, 1 week after intervention, 3 weeks after intervention, 6 weeks after intervention. Method of measurement: PANSS(Positive and Negative Symptom Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: One week after intervention,3 weeks after intervention,6 weeks after intervention. Method of measurement: Interview with patient.</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 and Technology Development-Ahwaz  Jondishapur University of Medical Sci</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-07-27</approval_date>
        <contact_name>Ahwaz Jondishapur University of Medical Sciences</contact_name>
        <contact_address>Ahwaz Jondishapur University of Medical Sciences, Golestan Blvd Ahwaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
