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/NCT06005155</url>
    </required_header>
    <id_info>
      <org_study_id>Lithium versus anticonvulsants</org_study_id>
      <nct_id>NCT06005155</nct_id>
    </id_info>
    <brief_title>Lithium Versus Anticonvulsants and the Risk of Physical Disorders</brief_title>
    <official_title>Lithium Versus Anticonvulsants and the Risk of Physical Disorders - Results From a Comprehensive Long-term Nation-wide Population-based Study Emulating a Randomised Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mental Health Services in the Capital Region, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mental Health Services in the Capital Region, Denmark</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nationwide population-based register linkage study covering the entire 5.9 million&#xD;
        inhabitants in Denmark systematically investigating the associations between sustained&#xD;
        long-term use of lithium versus lamotrigine and valproate, and the risk of a range of&#xD;
        physical disorders emulating a randomized trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar&#xD;
        disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium,&#xD;
        lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of&#xD;
        prior diagnosis of bipolar disorder (N= 156.678).&#xD;
  &#xD;
        Main analyses considered a patient exposed to a drug 92 days after a prescription and a&#xD;
        10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60&#xD;
        and 180 days after a prescription, respectively, and with 5- and 15-years follow-up,&#xD;
        respectively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arteriosclerosis</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Angina pectoris</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Myocardial infarction</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Myxoedema</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Osteoporosis</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dementia (separately for Alzheimer's disease and other dementia)</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parkinson's disease</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)</measure>
      <time_frame>1997 to 2021</time_frame>
      <description>Diagnosis in the Danish National Hospital Register</description>
    </primary_outcome>
    <enrollment type="Actual">169285</enrollment>
    <condition>Bipolar Disorder</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lithium</intervention_name>
      <description>Sustained long-term exposure</description>
      <other_name>Lamotrigene</other_name>
      <other_name>Valproate</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Nationwide population-based register linkage study covering the entire 5.9 million&#xD;
          inhabitants in Denmark and two cohorts. Cohort 1: all 12.607 patients with a diagnosis of&#xD;
          bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium,&#xD;
          lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of&#xD;
          prior diagnosis of bipolar disorder (N= 156.678).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine&#xD;
               or valproate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lars V Kessing, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Psychiatric Center Copenhagen</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Psychiatric Center Copenhagen</name>
        <address>
          <city>Copenhagen</city>
          <zip>2000</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 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 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lithium</keyword>
    <keyword>Lamotrigerne</keyword>
    <keyword>Valproate</keyword>
    <keyword>Physical disorders</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>Valproic Acid</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/NCT06005155
  org study id: Lithium versus anticonvulsants
  nct id: NCT06005155
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Nationwide population-based register linkage study covering the entire 5.9 million
        inhabitants in Denmark systematically investigating the associations between sustained
        long-term use of lithium versus lamotrigine and valproate, and the risk of a range of
        physical disorders emulating a randomized trial.
  The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar
        disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium,
        lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of
        prior diagnosis of bipolar disorder (N= 156.678).
  
        Main analyses considered a patient exposed to a drug 92 days after a prescription and a
        10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60
        and 180 days after a prescription, respectively, and with 5- and 15-years follow-up,
        respectively.
  observational model: Cohort
  time perspective: Retrospective
  measure: Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Arteriosclerosis
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Angina pectoris
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Myocardial infarction
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Myxoedema
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Osteoporosis
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Dementia (separately for Alzheimer's disease and other dementia)
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Parkinson's disease
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  measure: Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
  time frame: 1997 to 2021
  description: Diagnosis in the Danish National Hospital Register
  intervention type: Drug
  intervention name: Lithium
  description: Sustained long-term exposure
  other name: Lamotrigene
  other name: Valproate
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Lars V Kessing, Professor
  role: Principal Investigator
  affiliation: Psychiatric Center Copenhagen
  facility: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Bipolar Disorder
  mesh term: Valproic Acid