xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06011460</url>
    </required_header>
    <id_info>
      <org_study_id>NKBBN/355-183/2023</org_study_id>
      <nct_id>NCT06011460</nct_id>
    </id_info>
    <brief_title>Observation of Clozapine Treatment Safety in Bipolar Disorder.</brief_title>
    <acronym>CloGD</acronym>
    <official_title>Observation of Clozapine Treatment Safety in Bipolar Disorder.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Gdansk</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Gdansk</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the registry is to record incidence of adverse events during treatment with&#xD;
        clozapine in patients suffering from bipolar disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bipolar disorder, with its spectrum, remains a life-long and significant mental health&#xD;
        concern due to its unpredictable nature and varied symptomatology. Despite the wide array of&#xD;
        available treatments, some cases of bipolar disorder remain resistant to traditional&#xD;
        medications. Clozapine, traditionally used for treatment-resistant schizophrenia, has shown&#xD;
        promising results in managing resistant cases of bipolar disorder, particularly reducing the&#xD;
        risk of suicide. There are not enough controlled studies on clozapine, especially in&#xD;
        treatment resistant bipolar depression.&#xD;
  &#xD;
        There are certain limitations associated with the use of clozapine, primarily related to the&#xD;
        possibility of adverse events including agranulocytosis, myocarditis, pneumonia, intestinal&#xD;
        obstruction and seizures. Therefore, there is a need for more studies on safety and&#xD;
        tolerability of this treatment in patients with bipolar disorder.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">February 23, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Safety measures of clozapine treatment in patients with bipolar disorder.</measure>
      <time_frame>1 year</time_frame>
      <description>Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Bipolar Disorder</condition>
    <arm_group>
      <arm_group_label>Patients' name</arm_group_label>
      <description>Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5. Age from 18 to 65 years old.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Clozapine</intervention_name>
      <description>Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).&#xD;
  Age from 18 to 65 years old.</description>
      <arm_group_label>Patients' name</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with bipolar disorder treated with clozapine.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder&#xD;
               according to DSM-5.&#xD;
  &#xD;
            -  Age from 18 to 65 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to give fully written informed consent&#xD;
  &#xD;
            -  Patients unable to comply with the requirements&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wiesław J Cubała, M.D. PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medican University of Gdańsk</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Psychiatry, Medical University of Gdańsk</name>
        <address>
          <city>Gdańsk</city>
          <state>Pomorskie</state>
          <zip>80-214</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <reference>
      <citation>Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.</citation>
      <PMID>31488793</PMID>
    </reference>
    <reference>
      <citation>Wilkowska A, Cubala WJ. Clozapine As Transformative Treatment In Bipolar Patients. Neuropsychiatr Dis Treat. 2019 Oct 9;15:2901-2905. doi: 10.2147/NDT.S227196. eCollection 2019.</citation>
      <PMID>31632038</PMID>
    </reference>
    <reference>
      <citation>Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine in Treatment-Resistant Bipolar Disorder With Suicidality. Three Case Reports. Front Psychiatry. 2019 Jul 19;10:520. doi: 10.3389/fpsyt.2019.00520. eCollection 2019.</citation>
      <PMID>31379632</PMID>
    </reference>
    <reference>
      <citation>Delgado A, Velosa J, Zhang J, Dursun SM, Kapczinski F, de Azevedo Cardoso T. Clozapine in bipolar disorder: A systematic review and meta-analysis. J Psychiatr Res. 2020 Jun;125:21-27. doi: 10.1016/j.jpsychires.2020.02.026. Epub 2020 Feb 27.</citation>
      <PMID>32182485</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>clozapine</keyword>
    <keyword>bipolar disorder</keyword>
    <keyword>suicidality</keyword>
    <keyword>adverse events</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bipolar Disorder</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Clozapine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06011460
  org study id: NKBBN/355-183/2023
  nct id: NCT06011460
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of the registry is to record incidence of adverse events during treatment with
        clozapine in patients suffering from bipolar disorder.
  Bipolar disorder, with its spectrum, remains a life-long and significant mental health
        concern due to its unpredictable nature and varied symptomatology. Despite the wide array of
        available treatments, some cases of bipolar disorder remain resistant to traditional
        medications. Clozapine, traditionally used for treatment-resistant schizophrenia, has shown
        promising results in managing resistant cases of bipolar disorder, particularly reducing the
        risk of suicide. There are not enough controlled studies on clozapine, especially in
        treatment resistant bipolar depression.
  
        There are certain limitations associated with the use of clozapine, primarily related to the
        possibility of adverse events including agranulocytosis, myocarditis, pneumonia, intestinal
        obstruction and seizures. Therefore, there is a need for more studies on safety and
        tolerability of this treatment in patients with bipolar disorder.
  observational model: Case-Only
  time perspective: Prospective
  measure: Safety measures of clozapine treatment in patients with bipolar disorder.
  time frame: 1 year
  description: Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.
  arm group label: Patients' name
  description: Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5. Age from 18 to 65 years old.
  intervention type: Drug
  intervention name: Clozapine
  description: Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  Age from 18 to 65 years old.
  arm group label: Patients' name
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Wiesław J Cubała, M.D. PhD
  role: Principal Investigator
  affiliation: Medican University of Gdańsk
  facility: 
  country: Poland
  citation: Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.
  PMID: 31488793
  citation: Wilkowska A, Cubala WJ. Clozapine As Transformative Treatment In Bipolar Patients. Neuropsychiatr Dis Treat. 2019 Oct 9;15:2901-2905. doi: 10.2147/NDT.S227196. eCollection 2019.
  PMID: 31632038
  citation: Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine in Treatment-Resistant Bipolar Disorder With Suicidality. Three Case Reports. Front Psychiatry. 2019 Jul 19;10:520. doi: 10.3389/fpsyt.2019.00520. eCollection 2019.
  PMID: 31379632
  citation: Delgado A, Velosa J, Zhang J, Dursun SM, Kapczinski F, de Azevedo Cardoso T. Clozapine in bipolar disorder: A systematic review and meta-analysis. J Psychiatr Res. 2020 Jun;125:21-27. doi: 10.1016/j.jpsychires.2020.02.026. Epub 2020 Feb 27.
  PMID: 32182485
  responsible party type: Sponsor
  mesh term: Bipolar Disorder
  mesh term: Clozapine