<?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>IRCT20170103031741N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-11</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive behavioral therapy (CBT) for reducing signs and symptoms of bipolar disorder</public_title>
      <acronym>none</acronym>
      <scientific_title>Comparison of the efficacy of drug therapy with cognitive-behavioral therapy with the drug in reducing the symptoms and sings of type 2 bipolar disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24906</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A sample of bipolar patients is a type of admission in the psychiatric ward in an accessible manner, of which 20 will be contributed. Patients with Bipolar Mood Disorder in the department (based on psychiatric diagnosis) are divided into two groups of drugs and cognitive-behavioral therapy with the drug randomly.
The accident method will be simple. A random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized. To use a random number table, we first set the table numbers to read, for example, top, bottom, left, or right. The second default considering numbers for different groups for example, pair numbers for intervention A (drug treatment group) and individual numbers for intervention B (cognitive behavioral therapy group with medication).
-Randomization: Individual.
-Randomization Tool: Random Number Tables.
-Allocation concealment: Numbered drug containers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar Mood Disorder type one.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : will  be receive cognitive-behavioral therapy (12 sessions,Based on JC Wright method) with a common drug treatment such as sodium valproate (15mg/kg/Daily, PO) and lithium(400mg daily,PO) for 2 month . Intervention 2: Control group:  will be receive a common drug treatment such as sodium valproate (15mg/kg/Daily, PO) and lithium(400mg daily,PO) for 2 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Total data after unidentifiable people as SPSS can be shared.

When:
Six months later print the results.

To whom:
Researchers working in academia and academia.

Conditions:
In order to investigate narrative and data validation.

Where to obtain:
Fatemi Hospital, Department of Psychiatry, proprietary files of this study.

How to obtain:
Applying for access to project documentation, apply to the hospital's research council and then issue permission to access files and data.

Comments:
FF</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mehryar Nadermohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemi Hospital., Emam Khomeyni Ave., Isghah Sarey.,Ardebiln</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3324 2400</telephone>
        <email>m.nadermohammadi@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Parviz Molavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemi Hospital., Emam Khomeyni Eve., Isghah Sareyn., Ardebil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3323 2520</telephone>
        <email>fatemi@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age minimum 18 years and maximum 50 years
Minimum education third grade middle school
Minimum standards DSM-V criteria for the diagnosis of bipolar disorder type
People who experience a first episode of disease
Chronic patients who had at least 2 weeks of discontinuation And a new episode of recurrent disease and had been hospitalized.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having substance abuse
Having active thoughts of suicide
Having any comorbidity disorder accompanied by a psychotic clinical presentation.
Having OCD
Having any personality disorder.
Having impulse control disorder and aggression.
Any pregnant.
History of any psychiatric treatment in the past 6 months.
Hospitalized patients have a history of drug treatment without discontinuing the drug.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Chapter V </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>F31</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : will  be receive cognitive-behavioral therapy (12 sessions,Based on JC Wright method) with a common drug treatment such as sodium valproate (15mg/kg/Daily, PO) and lithium(400mg daily,PO) for 2 month .</i_keyword>
      <i_keyword>Control group:  will be receive a common drug treatment such as sodium valproate (15mg/kg/Daily, PO) and lithium(400mg daily,PO) for 2 month .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>High Mood. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Sexual interests. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Sleep. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Thought content. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Aggressive behavior. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Irritability. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Speech impairment. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Appearance. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Insight. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Motor activity. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
      <prim_outcome>Speech speed. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: Yang Mania Scale Response; Hamilton Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: At the beginning of the study and 2 months after the intervention. Method of measurement: FS36 Score.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-31</approval_date>
        <contact_name>Ethical Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Ardebil University of medical sciences.,University Square.,University Avenue.,Ardebill Ardebil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
