<?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>IRCT20200307046712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-06</date_registration>
      <primary_sponsor>Alborz University of Medical Science</primary_sponsor>
      <public_title>Evaluation of the effect of vitamin B1 and B6 in manic patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of vitamin B1 and B6 as an adjunct therapy to improve the symptoms of mania phase of bipolar disorder type I; in a double-blind and placebo-controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>67</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method of randomization: simple
Unit of randomization: individual
Tools used in randomization: table of random numbers
Randomization will be done in the absence of patients' sight, Blinding description: According to double-blinding, all the groups of patients will take their drugs without any knowledge about types of them. Also, the patients' nurse will give these drugs to the them according to the randomization the physician has made, without consciousness about types of them.</study_design>
      <phase>3</phase>
      <hc_freetext>Bipolar disorder.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: This group will take 1.5 mg/kg vitamin B1 plus 900 mg lithium bicarbonate. Intervention 2: Second international group: This group will take 0.6 mg/kg vitamin B6 plus 900 mg lithium bicarbonate. Intervention 3: Control group: This group will take one placebo plus 900 mg lithium bicarbonate each day. The placebo will be made in the laboratory of the Alborz University of Medical Science.</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 The data won,t be released until the publication of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shaghayegh Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>528,120 AVE,ERAM BOULEVARD</address>
        <city>KARAJ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3185746957</zip>
        <telephone>+98 26 3340 1629</telephone>
        <email>mvishaghayegh@gmail.com</email>
        <affiliation>Alborz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Zandifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province</address>
        <city>KARAJ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3147734568</zip>
        <telephone>+98 26 3255 8920</telephone>
        <email>zandifaratefe@gmail.com</email>
        <affiliation>Alborz university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diagnostic criteria of DSM-V for mania phase of patients with bipolar disorder
Having at least 14 scores in Young-Mania questionnaire
Aged between 18 to 50
Getting conscious letter of satisfaction from patient tutor</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any neurological, organic, cardiovascular and hepatic disorder according to patientsگ evidences or history
Existence of any other diagnosis in axis I disorders according to DSM-V
IQ less than 70 according to examiner clinical judge
Drug abuse (except nicotine and caffeine )
Alcohol abuse coincidentally
Women in reproductive ages without using a safe contraception
Patient with CHF (congestive heart failure) or liver disease
Absence of satisfaction for starting or continuing participating</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bipolar disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: This group will take 1.5 mg/kg vitamin B1 plus 900 mg lithium bicarbonate.</i_keyword>
      <i_keyword>Second international group: This group will take 0.6 mg/kg vitamin B6 plus 900 mg lithium bicarbonate.</i_keyword>
      <i_keyword>Control group: This group will take one placebo plus 900 mg lithium bicarbonate each day. The placebo will be made in the laboratory of the Alborz University of Medical Science.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mood symptoms  . Timepoint: In this study, mood symptoms will be assessed in the beginning of and at the end of the 8th week of the clinical trial. Method of measurement: Mood symptoms will be assessed according to the score of the Young-Mania questionnaire .</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognition state. Timepoint: In this study, the cognition state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial. Method of measurement: The cognition state of the patients will be assessed according to the score of the Minimal Mental State Exam (MMSE).</sec_outcome>
      <sec_outcome>The sleep state. Timepoint: In this study, the sleep state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial. Method of measurement: The sleep state pf the patients will be assessed according to the score of Pittsburgh Sleep Quality Questionnaire Index(PSQI).</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>Alborz University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-15</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province KARAJ Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
