<?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>IRCT20190530043769N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-26</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Efficacy of Rivastigmine Augementation to Antipsychotic Agents on Positive and Negative Symptoms and Quality of Life in Patients with Chronic Schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of Rivastigmine Augementation to Antipsychotic Agents on Positive and Negative Symptoms and Quality of Life in Patients with Chronic Schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Blinding description: Double blind: Participants, Patient care, The responsible person for gathering data, Hospital staff, Data analyzer.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Interference Group: this group includes chronic schizophrenia patients that receive Rivastigmine capsules (1.5 mg) twice daily along with the previous antipsychotic medication for eight weeks. The medication is produced in Razak factory. Patients will be examined daily regarding the side effects of medication. They will be assessed in three stages; at the start point, after four weeks and at the end of eight weeks, using PANSS questionnaires and life quality. Intervention 2: Control group: this group includes chronic schizophrenia patients that receive placebo twice daily along with the previous antipsychotic medication for eight weeks. Patients will be examined daily regarding the side effects of medication. They will be assessed in three stages; at the start point, after four weeks and at the end of eight weeks, using PANSS questionnaires and life quality.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After the clinical study, statistical tests and acquiring the results, the entire stages of study, including: history, method, discussion and conclusion will be shared as thesis and articles in the reputable and relevant journals.

When:
After being approved by supervisor, advisor and Referees, the thesis will be shared according the norms of Tabriz University of Medical Sciences.

To whom:
Thesis will be shared according to the norms of library to Tabriz University of Medical Sciences; also, the article will be shared according to the norms of journals.

Conditions:
The documents will be available according to the norms of university and journals, in order for the scientific community to be aware of the scientific results of this study.

Where to obtain:
To receive the documents please refer the library of Tabriz University of Medical Sciences.

How to obtain:
According to the approved stages of Tabriz University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Jahangiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Razi Hospital, Sheikh Mohammad KHiyabani Blvd, Elgoli, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167846184</zip>
        <telephone>+98 41 3380 4486</telephone>
        <email>za.jahangiri1986@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh Herizchi Ghadim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Razi Hospital, Sheikh Mohammad KHiyabani Blvd, Elgoli, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167846184</zip>
        <telephone>+98 41 3380 4486</telephone>
        <email>sherizchi@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with Chronic Schizophrenia
Patients treated with Antipsychotics</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug abuse
IQ less than 70
َAnother psychiatric disorder
Physical illness
ECT in the last two weeks
Sensitivity to Rivastigmine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Paranoid 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>Interference Group: this group includes chronic schizophrenia patients that receive Rivastigmine capsules (1.5 mg) twice daily along with the previous antipsychotic medication for eight weeks. The medication is produced in Razak factory. Patients will be examined daily regarding the side effects of medication. They will be assessed in three stages; at the start point, after four weeks and at the end of eight weeks, using PANSS questionnaires and life quality.</i_keyword>
      <i_keyword>Control group: this group includes chronic schizophrenia patients that receive placebo twice daily along with the previous antipsychotic medication for eight weeks. Patients will be examined daily regarding the side effects of medication. They will be assessed in three stages; at the start point, after four weeks and at the end of eight weeks, using PANSS questionnaires and life quality.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Efficacy of Rivastigmine. Timepoint: Efficacy of Rivastigmine in three stages: at the start point, after 4 weeks and at the end of study. Method of measurement: Positive, negative symptoms questionnaire in Chronic schizophrenia patients.</prim_outcome>
      <prim_outcome>Efficacy of rivastigmine. Timepoint: Efficacy of Rivastigmine in three stages: at the start point, after 4 weeks and at the end of study. Method of measurement: Quality of Life Questionnaire in Chronic schizophrenic Patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effect. Timepoint: Two months after starting therapy. Method of measurement: Medical history and examination.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-10</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz Razi Hospital, Sheikh Mohammad KHiyabani Blvd, Elgoli, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
