<?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>IRCT2015041521779N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-28</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Jondi Shapour University Of Medical Sciences of Ahvaz</primary_sponsor>
      <public_title>The effect of adding pyridostigmine to second generation antipsychotic drugs on schizophrenia symptoms: A double blind randomised placebo controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding pyridostigmine to second generation antipsychotic drugs on schizophrenia symptoms: A double blind randomised placebo controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18989</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Interventional group:this  group that include 15 schizophrenic patients are selected quite rondom and treated with 2 generation antipsychotic drugs , pyridostigmine tablet 60 mg    will add to main treatment daily for one month.It is worth mentioning that pyridostigmine is one of  anticholinestrase drugs and one of common treatment of MYASTHENIA GRAVIS disease.  At the begining and end of 4 weeks &#13;
we check PANSS and BPRS for paitients. Intervention 2: In placebo group that include 15 schizophrenic patients are selected rondom and treated with  2 generation antipsychotic drugs,  placebo tablet that is quite similar to pyridostigmine tablet will add to their main treatment for one months.At begining and end of 4 weeks , PANSS and BPRS scales will check for patients.</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 Pakseresht Syrous</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Hospital, Golestan Street, Ahvaz, Khouzestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135874366</zip>
        <telephone>+98 61337430025</telephone>
        <email>paks392003@yahoo.com</email>
        <affiliation>Jondi Shapour University of Medical Sciences of Ahvaz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Boostani Haatam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jondi Shapour University of Medical Sciences of Ahvaz , Golestan Street , Ahvaz, Khouzestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135874366</zip>
        <telephone>+98 61337430025</telephone>
        <email>boostani-h@yahoo.com</email>
        <affiliation>Jondi Shapour University of Medical Sciences of Ahvaz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main inclusion criteria  is having  schizophrenia disorder.inclusion criteria: The average  age between 20 to 40 years and knowing persian language and having consent of participation in this research and having no brain  organic disease and using no any anti depressants such as tricyclics  drugs and donepezi drug.&#13;
Exclusion criteria :demensia and severe organic disease and very old age and young age and other neurologic diseases that patients must use anticholinesterase drugs and use of tricyclic antidepressants and donepezil drug.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventional group:this  group that include 15 schizophrenic patients are selected quite rondom and treated with 2 generation antipsychotic drugs , pyridostigmine tablet 60 mg    will add to main treatment daily for one month.It is worth mentioning that pyridostigmine is one of  anticholinestrase drugs and one of common treatment of MYASTHENIA GRAVIS disease.  At the begining and end of 4 weeks &#13;
we check PANSS and BPRS for paitients.</i_keyword>
      <i_keyword>In placebo group that include 15 schizophrenic patients are selected rondom and treated with  2 generation antipsychotic drugs,  placebo tablet that is quite similar to pyridostigmine tablet will add to their main treatment for one months.At begining and end of 4 weeks , PANSS and BPRS scales will check for patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Schizophrenic Disorder  Symptom. Timepoint: In First And End Of 4 Weeks Of Research. Method of measurement: By Using Panss And Bprs Scales.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparsion between complications of adding pyridostigmine with 2 generation antipsycotic drugs versus complications of antipsychotics  alone. Timepoint: Along of research. Method of measurement: With recurrent  visit of patients.</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 of Jondi Shapour University Of Medical Sciences of Ahvaz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-31</approval_date>
        <contact_name>Ethics Committy of  Jondi Shapour University of Medical Sciences of Ahvaz</contact_name>
        <contact_address>Golestan  Street، Ahvaz ، Khouzestan Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
