<?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>IRCT20170606034348N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-11</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effect of memantin on cognitive performance in patient under electroconvolsive therpy (clinical trial)</public_title>
      <acronym>ect</acronym>
      <scientific_title>Effect of memantin on cognitive performance in patient under electroconvolsive therpy (clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38633</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: , Randomization description: In this study, a random number randomization tool was used, Blinding description: After initial examination, ECT candidates are randomly divided into control and case groups. Patients in the memantine group and patients in the placebo control group are capsules that are filled with ointment and placed in the memantine pill inside the capsule and divided into two groups A and B. None of the patients, researcher or analyst will know the grouping of the groups, and the third partner is aware of the division of A and B, and at the end of the work the groups receiving the placebo and the drug will be identified.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Cognitive impairment.</hc_freetext>
      <i_freetext>Control group: Control group: Memantine in the case group starts 24 hours before the start of the study with a dose of 10 mg and will increase to 20 mg in a week. And will continue until the end of session 6 of the ECT. The placebo control group will be given. The cognitive ability of the patients will be measured 24 hours before and 24 hours after the ECT session 6, as well as one month after the ECT atomic, using the MMSE (Mini Mental Status Examination) and the Aden Brook Cognitive Examination Test. We will use the MMSE Iranian version in this study..</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:
abstract
Full article file

When:
Start the access period 6 months after printing the results

To whom:
Researchers working in academia and academia or those working in the industry can apply for them

Conditions:
Maintaining a moral charter
Refer to the present article in their project

Where to obtain:
Babol university of medical science
Yahyanejad hospital
Angela Hamidia MD

How to obtain:
access period 6 months after printing the results
Researchers working in academia and academia

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Angela Hamidia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khomeyni Ave, Yahyanejad hospital</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4713566547</zip>
        <telephone>+98 11 3219 9596</telephone>
        <email>a.hamidia@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Angela Hamidia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>khomeini Ave, Yahyanejad Hospital</address>
        <city>babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4713566547</zip>
        <telephone>+98 11 3129 9596</telephone>
        <email>a.hamidia@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In this clinical trial, 60 patients over the age of 18 and under the age of 60 with bipolar disorder psychiatric illnesses will be admitted to the ECT since the beginning of the year 1396-97.All patients will undergo a full psychiatric assessment and patient disorder is recorded based on DSM-V.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age outcomes aged less than 18 years and over 60 years of age, alcohol dependence or drug and drug addiction (except nicotine and caffeine) within 3 months of admission, confirmed kidney disease, epilepsy, back Mental retardation, cognitive impairments such as delirium and dementia, history of memantine use in the past 3 months before entering the study, patients who are unable to perform tests due to distraction , gastrointestinal disturbances and memantine susceptibility, and during Studying or suffering from intolerance to increasing the dose of memantine, as well as patients who receive more than 6 ECT sessions, are excluded be.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Control group: Memantine in the case group starts 24 hours before the start of the study with a dose of 10 mg and will increase to 20 mg in a week. And will continue until the end of session 6 of the ECT. The placebo control group will be given. The cognitive ability of the patients will be measured 24 hours before and 24 hours after the ECT session 6, as well as one month after the ECT atomic, using the MMSE (Mini Mental Status Examination) and the Aden Brook Cognitive Examination Test. We will use the MMSE Iranian version in this study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The cognitive ability of the patients will be measured 24 hours before and 24 hours after the ECT session 6, as well as one month after the completion of the ECT using the MMSE (Mini Mental Status Examination) and the Aden Brook Cognitive Examination Test. We will use the MMSE Iranian version in this study. Timepoint: 24 hours before and 24 hours after the 6th session of the ECT, as well as one month after the completion of the ECT. Method of measurement: Eden Brook MMSE (Mini Mental Status Examination).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>As well as one month after the completion of the ECT using the MMSE (Mini Mental Status Examination) and the Aden Brook Cognitive Examination Test. We will use the MMSE Iranian version in this study. Timepoint: One month after the completion of the ECT. Method of measurement: In this research we will use the Iranian version of MMSE and Eden Brooke.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-10</approval_date>
        <contact_name>Babol University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Boulevard babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
