<?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>IRCT20200918048751N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-30</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of memantine in improving cognitive deficits,  quality of life and reducing the negative symptoms  in schizophrenic patients.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of memantine in improving cognitive deficits, quality of life and reducing the negative symptoms of schizophrenia patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51069</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals will be randomly assigned to two groups. For this purpose, first a random sequence will be created from the table of random numbers. Then the extracted even numbers will be assigned to the intervention group and the odd numbers will be assigned to the control group. This process will continue to reach the sample size, Blinding description: Participants and research physicians will not be aware of the distribution of the drug and placebo, which are similar in color, size, shape, and odor to the original drug. To hide the drugs and placebo will be placed in a sealed matte envelope numbered in a row. Envelopes will be prepared by a non-research person.</study_design>
      <phase>3</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to the routine treatment of schizophrenia (which includes one of the three antipsychotic drugs: clozapine, risperidone, olanzapine), Sobhan Company Memantine will be prescribed for three months. For this purpose, treatment with 5 mg memantine will be started and 5 mg weekly will be increased to 20 mg, then the 20 mg dose will be continued for two months. Intervention 2: Control group: In addition to routine treatment, the control group will receive a placebo. Routine treatment that includes one of three antipsychotic drugs: clozapine, risperidone, olanzapine. The follow-up period in the present study is 12 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the dissatisfaction of the participants, a decision was made not to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Joz Qanbari Reyhaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Beheshti Educational, Therapeutic and Psychiatric Center., Ark Square</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513615788</zip>
        <telephone>+98 24 3354 2403</telephone>
        <email>reyhane.jozghanbari@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Armani kian Alireza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Treatment., third floor.,  Bustan 2 .,University of Medical Sciences ., above Ayatollah Hospital ., Gavazang Road</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956111</zip>
        <telephone>+98 24 3301 8000</telephone>
        <email>dr.armmami@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diagnostic criteria (DSM-5) for patients with schizophrenia and at least two years after diagnosis
Age 18 to 50 years
Receive a fixed dose of antipsychotic for at least 8 weeks and for 4 weeks before enrollment
Continue treatment with at least one antipsychotic drug during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Outstanding neurological or organic disease in clinical and laboratory studies
Existence of another axis-based diagnosis (DSM-5)
Coexistence with mental retardation
Drug addiction or abuse (except nicotine and caffeine)
Inability to communicate
High risk of suicide
Receive ECT in the last two weeks
History of memantine sensitivity
Having kidney disease
Pregnancy and lactation
Do not use safe contraception in women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia, unspecified</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>Intervention group: In addition to the routine treatment of schizophrenia (which includes one of the three antipsychotic drugs: clozapine, risperidone, olanzapine), Sobhan Company Memantine will be prescribed for three months. For this purpose, treatment with 5 mg memantine will be started and 5 mg weekly will be increased to 20 mg, then the 20 mg dose will be continued for two months.</i_keyword>
      <i_keyword>Control group: In addition to routine treatment, the control group will receive a placebo. Routine treatment that includes one of three antipsychotic drugs: clozapine, risperidone, olanzapine. The follow-up period in the present study is 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attention of schizophrenic patients. Timepoint: In two time periods before starting the drug and 12 weeks after starting the drug. Method of measurement: Strop computer test.</prim_outcome>
      <prim_outcome>Executive performance. Timepoint: In two time periods before starting the drug and 12 weeks after starting the drug. Method of measurement: London Tower Computer Test.</prim_outcome>
      <prim_outcome>Processing speed. Timepoint: In two time periods before starting the drug and 12 weeks after starting the drug. Method of measurement: Strop computer test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Negative symptoms. Timepoint: In the three time periods before, 8 and 12 weeks after the start of the intervention. Method of measurement: Negative Symptoms Assessment Scale.</sec_outcome>
      <sec_outcome>The quality of life. Timepoint: Three time periods before, 8 and 12 weeks after the start of the intervention. Method of measurement: Specific quality of life questionnaire for schizophrenic 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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-15</approval_date>
        <contact_name>Ethics committee of zanjan University of Medical Sciences</contact_name>
        <contact_address>Therapeutic and Psychiatric Center, Ark Square, Shahid Dr. Beheshti Educational Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
