<?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>IRCT20210428051118N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-06</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Efficacy of vitamin B complex add-on therapy on positive, negative and cognitive symptoms of chronic schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of vitamin B complex and placebo as adjunctive therapy on positive, negative and cognitive symptoms in patients with chronic schizophrenia; A double-blind randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56887</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Http://www.Randomization.com software was used to randomly divide people into two groups, Blinding description: Capsules of the same shape were used for this purpose.</study_design>
      <phase>3</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: One placebo capsule daily (purchased from Poursina Pharmaceutical Company) , which is similar to the main drug in color, smell and taste, is added to their treatment regimen for three months. Intervention 2: Intervention group: One Bcomplex vitamin capsule daily (purchased from Poursina Pharmaceutical Company) is added to their treatment regimen   for three months.</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>Somayeh Aqmasheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1649739834</zip>
        <telephone>+98 21 7709 2854</telephone>
        <email>aqmasheh@gmqil.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Aqmasheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1649739834</zip>
        <telephone>+98 21 7709 2854</telephone>
        <email>aqmasheh@gmqil.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from Schizophrenia
Do not have any other psychiatric disorder other than schizophrenia, for which a structured interview by a psychiatrist and the patient's test results are used
Patients receiving atypical antipsychotic drug
Having IQ in the normal range by measuring IQ by Raven test
Obtain informed consent from the patient or his / her guardian</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any physically debilitating disease, whether prominent neurological or organic, including severe kidney and liver disease, for which a clinical examination by a physician and the patient's test results are used.
Misuse of drugs or medications in the last six months
Receive ECT in the last two weeks
Patients who are contraindicated in vitamin B complex consumption</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: One placebo capsule daily (purchased from Poursina Pharmaceutical Company) , which is similar to the main drug in color, smell and taste, is added to their treatment regimen for three months.</i_keyword>
      <i_keyword>Intervention group: One Bcomplex vitamin capsule daily (purchased from Poursina Pharmaceutical Company) is added to their treatment regimen   for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Loosening of association. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale).</prim_outcome>
      <prim_outcome>Delirium. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale).</prim_outcome>
      <prim_outcome>Delusion. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale).</prim_outcome>
      <prim_outcome>Strange behavior. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale).</prim_outcome>
      <prim_outcome>Disorganized speech. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale).</prim_outcome>
      <prim_outcome>Flat or blunted affect. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Poverty of speech or poverty of content of speech. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Thought blocking. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Inappropriate makeup and appearance. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Avolition. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Anhedonia. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Social withdrawal. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: PANSS (Positive And Negative Syndrome Scale)،Calgary Depression Scale for Schizophrenia.</prim_outcome>
      <prim_outcome>Working memory problems. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: Raven IQ Test،Montral Cognitive Assessment:MoCA.</prim_outcome>
      <prim_outcome>Cognitive impairment. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: Raven IQ Test،Montral Cognitive Assessment:MoCA.</prim_outcome>
      <prim_outcome>Attention deficit. Timepoint: When entering the study, the end of the fourth, eighth and twelfth week. Method of measurement: Raven IQ Test،Montral Cognitive Assessment:MoCA.</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>Tehran University of Social and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-13</approval_date>
        <contact_name>Ethics Committee of University of Rehabilitation and Social Sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences,  Koodkiar St., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
