<?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>IRCT20130726014170N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-23</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Ondonestrone and Granisetron in the Treatment of Obsessive-Compulsive Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Ondansetron and Granisetron Effectiveness in the Treatment of Obsessive-Compulsive Disorder with Inadequate Response to Selective Serotonin Reuptake Inhibitors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients is based on the use of the random permuted block method (allocation ratio 1:1, blocks of four). Treatment allocation is concealed from the participants and physicians rated the patients using sequentially numbered, opaque and sealed envelopes. Randomizations and ratings of the patients are performed by separate individuals, Blinding description: The patients, the psychologist who referred the patients, the general physician and psychologist who evaluated the patients and prescribed the medication and the statistician were all blind to allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Continued treatment with serotonin reuptake inhibitor along with oral ondansetron tablet 2 mg in twice daily (4 mg daily) for 18 weeks. Ondansetron was provided by Jaber Ibn Hayyan pharmaceutical company,Tehran, Iran. Intervention 2: Intervention group: Continued treatment with serotonin reuptake inhibitor along with oral granisetron tablet 1 mg in twice daily (2 mg daily) for 18 weeks. Granisetron was provided by Jaber Ibn Hayyan pharmaceutical company,Tehran, Iran. Intervention 3: Control group: Oral placebo tablets were administered daily for 18 weeks. The placebo were provided by Jaber Ibn Hayyan pharmaceutical company, Iran.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Sharafkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Shaghayegh 24 Ave, Kochaksara street</address>
        <city>قائم شهر</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4763658894</zip>
        <telephone>+98 11 4224 8158</telephone>
        <email>dr.sharafkhah@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Sharafkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Shaghayegh 24 Ave, Kochaksara street</address>
        <city>Ghaemshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4763658894</zip>
        <telephone>+98 11 4224 8158</telephone>
        <email>dr.sharafkhah@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of OCD established by clinical interview (using The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Axis I Disorders)
Resistant or inadequacy of Serotonin reuptake inhibitor (SRIs) treatment response</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, substance dependence or abuse, and other comorbid DSM-IV Axis I disorders
History of seizure, suicidal ideationو and significant head trauma
Recent receiving antipsychotics in the treatment of obsessive-compulsive disorder
Intelligence quotient less than 70
history of treatment resistance
pregnancy and/or lactation
Having significant cardiovascular, hepatic, renal or pulmonary diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Continued treatment with serotonin reuptake inhibitor along with oral ondansetron tablet 2 mg in twice daily (4 mg daily) for 18 weeks. Ondansetron was provided by Jaber Ibn Hayyan pharmaceutical company,Tehran, Iran.</i_keyword>
      <i_keyword>Intervention group: Continued treatment with serotonin reuptake inhibitor along with oral granisetron tablet 1 mg in twice daily (2 mg daily) for 18 weeks. Granisetron was provided by Jaber Ibn Hayyan pharmaceutical company,Tehran, Iran.</i_keyword>
      <i_keyword>Control group: Oral placebo tablets were administered daily for 18 weeks. The placebo were provided by Jaber Ibn Hayyan pharmaceutical company, Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes from baseline Yale-Brown Obsessive Compulsive Scale (YBOCS) total, Obsession and Compulsion subscale score. Timepoint: Every two weeks for 18 weeks. Method of measurement: Yale-Brown Obsessive Compulsive Scale (YBOCS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Partial treatment response. Timepoint: Every two weeks for 18 weeks. Method of measurement: Yale-Brown Obsessive Compulsive Scale (YBOCS).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-05</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Shahid Shiroodi St., Aalam Al-Hoda St., Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
