<?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>IRCT2015112225191N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-17</date_registration>
      <primary_sponsor>Iran University of Medical Sciences Vice chancellor for research</primary_sponsor>
      <public_title>Efficacy of Clozapine in Patients with Prolonged Methamphetamine Induced Psychotic Disorder: A Single-blind Comparison With Olanzapine</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Clozapine in Patients with Prolonged Methamphetamine Induced Psychotic Disorder: A Single-blind Comparison With Olanzapine in drug abusers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Resistant Psychosis Induced by Methamphetamine.</hc_freetext>
      <i_freetext>Intervention 1: In the first stage of a medical history and medical examination will be done and then the patient will be taken. Complete blood count tests Valktrvkardyvgram or ECG at baseline for all patients will be performed. For the group treated with clozapine, based on the standard of care protocol venous blood sampling blood cell count every week until the end of the six week study and measurement of liver enzymes is done with and for the group treated with olanzapine retesting of blood samples After six weeks of intravenous treatment Sharveh study done to assess liver enzymes. Patients will be selected by convenience sampling method and randomly divided into two groups of 20 by minimizing a group treated with clozapine and olanzapine will be the second group.&#13;
 In addition to the above-mentioned questionnaire, a demographic questionnaire made by the researcher, including age, sex, education, duration of abuse, the age of onset of drug use, the type of substance, other drug use, age at onset of psychotic symptoms at their disposal to complete will be placed. Clozapine treatment dose of 6.25 mg up to 450 mg on the first day and will continue. Intervention 2: In the first stage of a medical history and medical examination will be done and then the patient will be taken. CBC tests Valktrvkardyvgram or ECG at baseline for all patients will be performed. For the group treated with olanzapine retesting of blood samples after treatment Sharveh six week study done to assess liver enzymes. Olanzapine dose of 5 mg to 15 mg on the first day and will continue.</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 Behnam Shariati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasool Hospital, St. Mansouri,, St.Niayesh, Starkhan,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6435 2331</telephone>
        <email>behnamshariatimd@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Behnam Shariati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Behavioral Sciences and Health psycho Tehran Psychiatric Institute, Niayesh street,Sattar Khan Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6435 2331</telephone>
        <email>.</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- A psychotic disorder caused by prolonged use of methamphetamine (more than 1 month psychotic and  at the same time cocaine has not); 2- obtaining the informed consent of the patient's guardian; 3- The absence of mental retardation (moderate or severe); 4- Non-organic neurological disease leading to clinical standpoint.&#13;
Exclusion criteria: 1- If the loss of white blood cells or neutrophils less than 3,000 is less than 1,500; 2- Unwillingness to continue to participate in the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>This block contains a wide variety of disorders that differ in severity and clinical form but that are all related to the use of one or more drugs, which may or may not prescribe medicine. The third letter of the code identify the materials involved, and </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>In the first stage of a medical history and medical examination will be done and then the patient will be taken. Complete blood count tests Valktrvkardyvgram or ECG at baseline for all patients will be performed. For the group treated with clozapine, based on the standard of care protocol venous blood sampling blood cell count every week until the end of the six week study and measurement of liver enzymes is done with and for the group treated with olanzapine retesting of blood samples After six weeks of intravenous treatment Sharveh study done to assess liver enzymes. Patients will be selected by convenience sampling method and randomly divided into two groups of 20 by minimizing a group treated with clozapine and olanzapine will be the second group.&#13;
 In addition to the above-mentioned questionnaire, a demographic questionnaire made by the researcher, including age, sex, education, duration of abuse, the age of onset of drug use, the type of substance, other drug use, age at onset of psychotic symptoms at their disposal to complete will be placed. Clozapine treatment dose of 6.25 mg up to 450 mg on the first day and will continue</i_keyword>
      <i_keyword>In the first stage of a medical history and medical examination will be done and then the patient will be taken. CBC tests Valktrvkardyvgram or ECG at baseline for all patients will be performed. For the group treated with olanzapine retesting of blood samples after treatment Sharveh six week study done to assess liver enzymes. Olanzapine dose of 5 mg to 15 mg on the first day and will continue</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of Symptoms and Psychosis Protests. Timepoint: Baseline, the end of the fourth week and eighth week. Method of measurement: Based on the PANSS Scale.</prim_outcome>
      <prim_outcome>Craving. Timepoint: At baseline, the end of the fourth week and eighth week. Method of measurement: Craving Beliefs Questionnaire (CBQ.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Extrapyramidal Side Effects. Timepoint: Baseline, the end of the fourth week and eighth week. Method of measurement: Scale Extrapyramidal  Side Effects ((ESRs.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>none</sec_id>
        <issuing_authority>none</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-23</approval_date>
        <contact_name>Mental Health Research Center, Iran University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>School of Behavioral Sciences and Health psycho Tehran Psychiatric Institute, Niayesh street,Sattar Khan Street, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
