<?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>IRCT2016062623705N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-03</date_registration>
      <primary_sponsor>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences , Kermanshah Univers</primary_sponsor>
      <public_title>The effect of augmentation of Gabapentin and Memantine with Selective Serotonin Re uptake Inhibitors (SSRIs) in treatment of patients with Obsessive Compulsive Disorder (OCD).</public_title>
      <acronym></acronym>
      <scientific_title>The effect and no effect of augmentation of Gabapentin and Memantine with Selective Serotonin Reuptake Inhibitors (SSRIs) in treatment of patients with Obsessive Compulsive Disorder (OCD).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20212</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive Compulsive Disorder.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group 1, the participant will receive a SSRI drugs with Memantine (SSRI with a dose of 20 mg, Memantine 5 mg) daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured. Intervention 2: In the control group, the participant will receive a SSRI drugs include Fluoxetine with placebo(Fluoxetine40 to 60 mg ) daily,then the questionnaire will be re-distributed at the baseline, 4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured. Intervention 3: In the experimental group 2, the participant will receive a SSRI drugs with Gabapentin (SSRI with a dose of 20 mg,  Gabapentin150 mg) daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder  will be measured.</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. Haniyeh Gharehbaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar square, Farabi Hospital</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3827 6683</telephone>
        <email>b.rahami2556@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vahid Farnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar square, Farabi Hospital</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3826 4513</telephone>
        <email>vfarnia@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Diagnosis of obsessive-compulsive disorder according to the DSM-5 by psychologist; patients that their first reference for treatment or at least one month from cutting drug treatment is passed; Age range 20-40 years.&#13;
Exclusion criteria: History of organic disease Seizures, diabetes, liver or kidney failure, hypothyroidism; Concomitant use of cardiac medications, Blood pressure, hormones, thyroid; Having other major psychiatric disease and substance abuse; Medical allergy to SSRI, Memantine with Gabapentin; Unwillingness participate in the study; Require hospitalization or receive ECT.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ّF42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive Compulsive Disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group 1, the participant will receive a SSRI drugs with Memantine (SSRI with a dose of 20 mg, Memantine 5 mg) daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured</i_keyword>
      <i_keyword>In the control group, the participant will receive a SSRI drugs include Fluoxetine with placebo(Fluoxetine40 to 60 mg ) daily,then the questionnaire will be re-distributed at the baseline, 4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured.</i_keyword>
      <i_keyword>In the experimental group 2, the participant will receive a SSRI drugs with Gabapentin (SSRI with a dose of 20 mg,  Gabapentin150 mg) daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder  will be measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive-compulsive disorder. Timepoint: The beginning of the study (baseline), week four and end of the study (week eight). Method of measurement: Based on the severity of obsessive-compulsive disorder.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences , Kermanshah Univers</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-11</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
