<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/NCT01734278</url>
  </required_header>
  <id_info>
    <org_study_id>OBSERVA</org_study_id>
    <nct_id>NCT01734278</nct_id>
  </id_info>
  <brief_title>Observational Post-Authorisation Safety Study of Asenapine (Sycrest)</brief_title>
  <acronym>OBSERVA</acronym>
  <official_title>An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professor Saad Shakir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Drug Safety Research Unit, Southampton, UK</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to evaluate the use and short term safety of&#xD;
      Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United&#xD;
      Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by&#xD;
      the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the&#xD;
      manufacturer of Sycrest.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of selected identified risks of asenapine in the mental health care trust setting</measure>
    <time_frame>12 weeks after asenapine is first prescribed</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Manic Disorder</condition>
  <arm_group>
    <arm_group_label>Asenapine</arm_group_label>
    <description>Patients prescribed asenapine for any indication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is a non-interventional study.</description>
    <arm_group_label>Asenapine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients prescribed asenapine in a NHS Mental Health Trust in England.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients for whom a study questionnaire containing useful information has been&#xD;
             returned&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not provide consent&#xD;
&#xD;
          -  Patients within selected institutions (for example prisons)&#xD;
&#xD;
          -  Patients who commenced treatment between date of market launch (to be confirmed) and&#xD;
             study start&#xD;
&#xD;
          -  Enrolled patients for whom both the baseline and 12-week questionnaires are returned&#xD;
             blank (contain no clinical information)&#xD;
&#xD;
          -  Enrolled patients for whom the psychiatrist, designated member of clinical care team,&#xD;
             or study facilitator from the DSRU reports that the patient did not take or was never&#xD;
             prescribed asenapine&#xD;
&#xD;
          -  Enrolled patients for whom there is evidence to suggest duplication of patients&#xD;
&#xD;
          -  Enrolled patients for whom informed written or verbal notification is received by DSRU&#xD;
             indicating that they no longer wish to participate at any stage of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>South Staffordshire and Shropshire Healthcare NHS Foundation Trust</name>
      <address>
        <city>Stafford</city>
        <state>Staffordshire</state>
        <zip>ST16 3SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>July 30, 2018</last_update_submitted>
  <last_update_submitted_qc>July 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Drug Safety Research Unit, Southampton, UK</investigator_affiliation>
    <investigator_full_name>Professor Saad Shakir</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01734278
org study id: OBSERVA
nct id: NCT01734278
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this observational study is to evaluate the use and short term safety of
      Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United
      Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by
      the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the
      manufacturer of Sycrest.
observational model: Cohort
time perspective: Prospective
measure: The incidence of selected identified risks of asenapine in the mental health care trust setting
time frame: 12 weeks after asenapine is first prescribed
arm group label: Asenapine
description: Patients prescribed asenapine for any indication.
intervention type: Other
intervention name: No intervention
description: This is a non-interventional study.
arm group label: Asenapine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: Drug Safety Research Unit, Southampton, UK
investigator full name: Professor Saad Shakir
investigator title: Director
mesh term: Bipolar Disorder