<?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>IRCT20150822023705N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-17</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of adding famotidine and vitamin B6 to standard drug treatment in patients with schizophrenia disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of adding famotidine and vitamin B6 to standard drug treatment in reducing negative symptoms in patients with schizophrenia disorder: a clinical trial with a control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69525</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two equal groups (A and B) based on a randomized size 8-block design using random allocation software. To randomly assign 80 patients to the intervention and control groups, 8 different blocks of 10 different letters A and B, which indicate Famotidine/vitamin B6 and placebo groups respectively, will be initially created. These blocks will be numbered from one to eight. In the next step, each of these blocks will be randomly selected by performing lottery using 8 cards with numbers 1 to 8 on them. Thus, in each lottery, by selecting a block, a combination of 10 letters of the letters A (Famotidine/vitamin B6 group) and B (placebo group) will be obtained. At the end of the 8 drawings, after selecting 8 blocks, a total of 80 letters A and B will be obtained. The resulting combination of letters A and B is single, and will be placed in 80 separate and sealed envelopes, respectively. Following each patient recourse, an envelope will be opened to determine the group of that patient, Blinding description: The medication and placebo are delivered to the patient without sticking the name of the medication. The doctor is also unaware of the type of drug used in each group. The color and smell of the main drug and placebo are the same.</study_design>
      <phase>2</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group will receive the combination of famotidine/vitamin B6 pills in three months. The daily dose will be 1 pill of 190 mg (famotidine, 40 mg and vitamin B6, 150 mg). These pills will be given to patients without awareness of the patient and the examiner. Famotidine/vitamin B6 pills will be purchased from Caspin Daru Pharmaceutical Company. Intervention 2: Control group: The control group will receive placebo treatment in three months. Daily drug intake will be 1 pill of 190 mg. Placebo pills in terms of shape, size, color and smell are similar to the Famotidine/vitamin B6 pills. placebo will be purchased from Caspin Daru Pharmaceutical Company.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shakiba Salmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farabi Hospital; Isar square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851115</zip>
        <telephone>+98 83 3826 4513</telephone>
        <email>shakiba.salmani@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Kakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farabi Hospital; Isar square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851115</zip>
        <telephone>+98 83 3826 4513</telephone>
        <email>faribakakery@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Schizophrenia Disorder diagnoses with negative symptoms according to Diagnostic and Statistical Manual of Mental Disorders fifth edition by a psychiatrist
under treatment with aripiprazole</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disagreement to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group will receive the combination of famotidine/vitamin B6 pills in three months. The daily dose will be 1 pill of 190 mg (famotidine, 40 mg and vitamin B6, 150 mg). These pills will be given to patients without awareness of the patient and the examiner. Famotidine/vitamin B6 pills will be purchased from Caspin Daru Pharmaceutical Company.</i_keyword>
      <i_keyword>Control group: The control group will receive placebo treatment in three months. Daily drug intake will be 1 pill of 190 mg. Placebo pills in terms of shape, size, color and smell are similar to the Famotidine/vitamin B6 pills. placebo will be purchased from Caspin Daru Pharmaceutical Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of negative symptoms. Timepoint: before intervention- 6 weeks later- 12 weeks late. Method of measurement: Positive and Negative Symptom Scale.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-08</approval_date>
        <contact_name>Ethics committee Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research Affairs, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti boulevard Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
