<?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>IRCT20200719048138N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-19</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect of fluoxetine on the clinical prognosis in patients with Optic neuritis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of treatment by fluoxetine on clinical prognosis in patients with Optic neuritis in comparison between drug and placebo groups.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49900</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In order to randomize allocation of patients in each group of study, we'll use the permuted block randomization method by means of blocks with 4 in size. According to the number of patients in each group of study (50 patients in each group and over all 100 cases in the study), 25 blocks of four by means of online website 
 (www.sealedenvelope.com) will produce. For concealment, during randomization we'll use specific codes written on drug or placebo boxes which have been produced by computer. Each patient who enters the study will receive a box of drug or placebo according to the, Blinding description: During this study, participant will not be aware about if he receiving the drug or placebo because the shape and other features of boxes of both drugs and placebos are the same. The interviewer and investigator also will not be aware of which patients have received drug or placebo. But the analyzer knows the patients who received drug and the patients who received placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>The Optic neuritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: receivers of fluoxetine antidepressant, 20 mg daily for 6 month. Intervention 2: Control group: Control group: Receivers of placebo of fluoxetine that are resemble exactly in appearance features to fluoxetine for 6 month.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Poormousa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86709</telephone>
        <email>zpourmousa@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Poormousa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86709</telephone>
        <email>zpourmousa@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian patients
Age over 18 years old
Patients diagnosed with Optic neuritis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of multiple sclerosis
cataract, glaucoma ( open or close angle ) congenital eye diseases such as coloboma and involvement with other disorders effecting the central visual field
Patients with past medication history of using fluoxetine or other psychotherapeutics including antidepressants
psychological disease
medication history of arthemeter، astemizol, cisapride, eliglustat, goserelin, isocarboxazide, artemether, leuprolide, linezolid, lumefantrine, methylene blue, phenelzine, pimozide, procarbazine, selegiline, thioridazine, tranylcypromine
Patients diagnosed with autoimmune and collagen vascular diseases
Trauma or history of ophthalmologic surgeries
Interval between involvement and interview more than 3 weeks
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Optic neuritis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: receivers of fluoxetine antidepressant, 20 mg daily for 6 month</i_keyword>
      <i_keyword>Control group: Control group: Receivers of placebo of fluoxetine that are resemble exactly in appearance features to fluoxetine for 6 month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1)Visual acuity: precision of vision assessed by snelene chart. Timepoint: On first visit and 6th month after initiation of treatment. Method of measurement: Visual acuity: snelene chart.</prim_outcome>
      <prim_outcome>VEP (Visual evoked potential) test: both time ( latency) and amplitude parameters of VEP test will measure. Timepoint: On first visit and 6th month after initiation of treatment. Method of measurement: VEP test by means of VEP device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>OCT: thickness of retina. Timepoint: OCT: on first visit and 6th month after initiation of treatment. Method of measurement: OCT: OCT device.</sec_outcome>
      <sec_outcome>Perimetry: percent of scotoma in visual field. Timepoint: Perimetry: On first visit and 6th month after initiation of treatment. Method of measurement: Perimetry: digital perimetry device.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-11</approval_date>
        <contact_name>Ethics committee of the Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences (IUMS), Hemmat highway, Tehran, iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
