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/NCT05962216</url>
    </required_header>
    <id_info>
      <org_study_id>ReSD-HK</org_study_id>
      <nct_id>NCT05962216</nct_id>
    </id_info>
    <brief_title>Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders</brief_title>
    <acronym>ReSD</acronym>
    <official_title>Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Albert Kar-Kin Chung</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Hong Kong</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders,&#xD;
        antipsychotics, especially the second-generation antipsychotics (SGAs) have also been&#xD;
        recommended as augmenting agents for treating depression. Dopaminergic agents, including both&#xD;
        dopamine D2/D3 antagonists and dopamine partial D2 agonists, have been effective for treating&#xD;
        psychosis and schizophrenia. Amongst all SGAs, those with partial D2 agonistic property are&#xD;
        generally acknowledged to have better side-effect profiles with lower incidence of&#xD;
        extrapyramidal side-effects, prolactin increase, weight gain, QTc prolongation, and metabolic&#xD;
        syndrome, as well as more efficacious in alleviating depressive symptoms. Up-to-date, three&#xD;
        SGAs, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial&#xD;
        D2 agonism. ReSD-HK study is part of the ReSD Asian Study aiming to carefully evaluate a&#xD;
        cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as&#xD;
        treatment for schizophrenia and/or depression in a real-life clinical setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a 6-month, non-interventional, prospective naturalist study that adult patients&#xD;
        (18-65 years old) receiving brexpiprazole for treatment of psychosis and/or as adjunctive&#xD;
        treatment for major depressive disorder are eligible to participate. Minimal exclusion&#xD;
        criteria are employed to fit the usual real-life setting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Change in Brief Psychiatric Rating Scale-24 in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy measures the change from baseline, to that at 3rd and 6th months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Global Impression in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy measures the change from baseline, to that at 3rd and 6th months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Beck Anxiety Inventory in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy measures the change from baseline, to that at 3rd and 6th months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Beck Depression Inventory in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy measures the change from baseline, to that at 3rd and 6th months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Digital Symbol Substitution Test in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy measures the change from baseline, to that at 3rd and 6th months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy measures the change from baseline, to that at 3rd and 6th months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Glasgow Antipsychotic Side-effects Scale in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Tolerability measures at baseline, at 3rd and 6th months. Higher score means greater side-effects with the minimum score of 0 and the maximum score of 63.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Simpson-Angus Scale in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barnes Akathisia Rating Scale in 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>QTc interval</measure>
      <time_frame>6 months</time_frame>
      <description>Tolerability measures at baseline and 6th months</description>
    </other_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Psychosis</condition>
    <condition>Depression</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Brexpiprazole</intervention_name>
      <description>Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders</description>
      <other_name>Rexulti</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects suffering from psychosis or depressive disorders who are treated with the oral&#xD;
          medication, brexpiprazole&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 18- 65 years old at the time of enrollment&#xD;
  &#xD;
            -  Able to read and communicate in English and/or Chinese&#xD;
  &#xD;
            -  Able to give informed consent&#xD;
  &#xD;
            -  Has been diagnosed according to Diagnostic and Statistical Manual of Mental Disorders,&#xD;
               5th edition (DSM-5), or International Statistical Classification of Diseases and&#xD;
               Related Health Problems 10th revision (ICD-10) to have either Psychotic Disorders&#xD;
               (F10-F19.5, F20-23, F25, F32-F33)&#xD;
  &#xD;
            -  is receiving brexpiprazole as treatment for less than 4 weeks at the time of&#xD;
               recruitment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years old&#xD;
  &#xD;
            -  Unable to read English or Chinese&#xD;
  &#xD;
            -  Unable to give informed consent&#xD;
  &#xD;
            -  Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation&#xD;
               (ICD-10 F70-73)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Albert KK Chung, MBBS</last_name>
      <phone>2255 4486</phone>
      <email>Chungkka@hku.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Queen Mary Hospital</name>
        <address>
          <city>Hong Kong</city>
          <zip>000000</zip>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Albert KK Chung</last_name>
        <phone>2255 4486</phone>
        <email>chungkka@hku.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Dr. Albert Kar-Kin Chung</investigator_full_name>
      <investigator_title>Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brexpiprazole</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>To be shared within the ReSD Asian Study Group</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Five year after the study period upon the last subject recruitments in the respective study sites.</ipd_time_frame>
      <ipd_access_criteria>For those named investigator who are engaged in the ReSD Asian Study with agreement signed.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05962216
  org study id: ReSD-HK
  nct id: NCT05962216
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders,
        antipsychotics, especially the second-generation antipsychotics (SGAs) have also been
        recommended as augmenting agents for treating depression. Dopaminergic agents, including both
        dopamine D2/D3 antagonists and dopamine partial D2 agonists, have been effective for treating
        psychosis and schizophrenia. Amongst all SGAs, those with partial D2 agonistic property are
        generally acknowledged to have better side-effect profiles with lower incidence of
        extrapyramidal side-effects, prolactin increase, weight gain, QTc prolongation, and metabolic
        syndrome, as well as more efficacious in alleviating depressive symptoms. Up-to-date, three
        SGAs, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial
        D2 agonism. ReSD-HK study is part of the ReSD Asian Study aiming to carefully evaluate a
        cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as
        treatment for schizophrenia and/or depression in a real-life clinical setting.
  This is a 6-month, non-interventional, prospective naturalist study that adult patients
        (18-65 years old) receiving brexpiprazole for treatment of psychosis and/or as adjunctive
        treatment for major depressive disorder are eligible to participate. Minimal exclusion
        criteria are employed to fit the usual real-life setting.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in Brief Psychiatric Rating Scale-24 in 6 months
  time frame: 6 months
  description: Efficacy measures the change from baseline, to that at 3rd and 6th months
  measure: Change in Clinical Global Impression in 6 months
  time frame: 6 months
  description: Efficacy measures the change from baseline, to that at 3rd and 6th months
  measure: Change in Beck Anxiety Inventory in 6 months
  time frame: 6 months
  description: Efficacy measures the change from baseline, to that at 3rd and 6th months
  measure: Change in Beck Depression Inventory in 6 months
  time frame: 6 months
  description: Efficacy measures the change from baseline, to that at 3rd and 6th months
  measure: Change in Digital Symbol Substitution Test in 6 months
  time frame: 6 months
  description: Efficacy measures the change from baseline, to that at 3rd and 6th months
  measure: Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months
  time frame: 6 months
  description: Efficacy measures the change from baseline, to that at 3rd and 6th months
  measure: Glasgow Antipsychotic Side-effects Scale in 6 months
  time frame: 6 months
  description: Tolerability measures at baseline, at 3rd and 6th months. Higher score means greater side-effects with the minimum score of 0 and the maximum score of 63.
  measure: Simpson-Angus Scale in 6 months
  time frame: 6 months
  description: Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.
  measure: Barnes Akathisia Rating Scale in 6 months
  time frame: 6 months
  description: Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.
  measure: QTc interval
  time frame: 6 months
  description: Tolerability measures at baseline and 6th months
  intervention type: Drug
  intervention name: Brexpiprazole
  description: Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders
  other name: Rexulti
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Albert KK Chung, MBBS
  phone: 2255 4486
  email: Chungkka@hku.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Sponsor-Investigator
  investigator affiliation: The University of Hong Kong
  investigator full name: Dr. Albert Kar-Kin Chung
  investigator title: Clinical Assistant Professor
  mesh term: Schizophrenia
  mesh term: Depressive Disorder
  mesh term: Brexpiprazole
  sharing ipd: Yes
  ipd description: To be shared within the ReSD Asian Study Group
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Five year after the study period upon the last subject recruitments in the respective study sites.
  ipd access criteria: For those named investigator who are engaged in the ReSD Asian Study with agreement signed.