<?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>IRCT20210608051514N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-20</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>treatment schizophrenia patients: double-blind randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Title: The Effectiveness of tDCS over the DLPFC on reducing clinical symptomsimproving working memory and aberrant EEG functional connectivity in resting state schizophrenia patients: double-blind randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56739</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects are selected from purposive sampling method and using simple randomization method, based on which the subjects are assigned to the two groups of control and experiment by tossing coins.This method is used for two-group clinical trials, according to which one group is called a lion, and the other is called a line, and thus the number of coin samples is tossed, Blinding description: In this study, the clinical evaluator and therapist will be blind to assigning subjects to control and experimental groups. In addition, we use the clinical evaluator separately for baseline assessments and follow-up, and the therapist separately for treatment.Subjects will also be assigned to control groups or blind experiments, so that subjects will not meet outside of the sessions and will visit at times when no other subjects will be present.</study_design>
      <phase>N/A</phase>
      <hc_freetext>schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment with stimulation of extracranial direct current with a current of 2 mA for 20 minutes on the lateral dorsal forehead cortex will receive ten sessions for five days and two sessions a day. Intervention 2: Control group: Treatment with stimulation of extracranial direct current with a current intensity of two milliamperes for 40 seconds on the lateral dorsal forehead cortex will receive ten sessions for five days and two sessions daily.</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:
All information of individuals except names and confidential information will be published at the end of the research. Publishable information including: therapeutic changes, results of questionnaires, statistical results of signal analysis, dose and medication used

When:
The results of this research will be published three months after the end of the research.

To whom:
All researchers, researchers, colleagues, and others

Conditions:
To carry out similar projects and if all the material and intellectual rights of researchers are observed.

Where to obtain:
Contact the following email address to receive the documentation:
Farahnaz Yousefi Master of Clinical Psychology
farahnaz.yosefi76@gmail.com
Address: Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province

How to obtain:
The data will be provided to the applicant after receiving the e-mail of the applicant and observing the material and intellectual rights of the researchers.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7531974143</zip>
        <telephone>+98 21 8670 5504</telephone>
        <email>mohsen.dadashi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7531974143</zip>
        <telephone>+98 21 8675 6604</telephone>
        <email>mohsen.dadashi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a diagnosis of schizophrenia
Having the ability to write informed consent
Experience positive symptoms despite a month of stabilization in medication dose
The same dose and medicine
Being a man
Being right-handed
Age 65_18 years
The dose of antipsychotic medication used by the person is constant at the beginning and during the research
Stabilization in drug treatment for at least 6 weeks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Have a history of suicide and abuse of alcohol and substances other than caffeine and tobacco in the past month
Have a history of neurological diseases such as Parkinson's, epilepsy, seizures, stroke and cardiovascular problems
Having diseases related to the scalp
Having a history of head trauma and the presence of a device or tool in the head
Withdrawal from the study after absence in two consecutive sessions of treatment.</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Treatment with stimulation of extracranial direct current with a current of 2 mA for 20 minutes on the lateral dorsal forehead cortex will receive ten sessions for five days and two sessions a day.</i_keyword>
      <i_keyword>Control group: Treatment with stimulation of extracranial direct current with a current intensity of two milliamperes for 40 seconds on the lateral dorsal forehead cortex will receive ten sessions for five days and two sessions daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative symptoms:Theoretical definition: It is one of the clinical symptoms in schizophrenia that includes superficial emotion, poor speech, lack of motivation, unhappiness and social transgression.Operational definition: The score that a person gets from the positive and negative symptoms of schizophrenia.Positive symptoms: Theoretical definition includes delusions, delusions, disturbed speech, and disturbed behavior that persist throughout a one-month period.Operational definition: The score that a person gets from the positive and negative symptoms of schizophrenia. Timepoint: Pre-test-post-test-one-month follow-up-quarterly follow-up. Method of measurement: The score that a person gets from the questionnaire for measuring positive and negative symptoms in schizophrenia.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Working memory:Theoretical definition: means the ability to store and manipulate information in memory, which is an essential prerequisite for complex cognitive tasks such as learning, reasoning and comprehension. Timepoint: Pre-test-post-test-one-month follow-up-quarterly follow-up. Method of measurement: The score a person gets from the n back test.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-25</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
