<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/NCT02969499</url>
  </required_header>
  <id_info>
    <org_study_id>H15-02351</org_study_id>
    <nct_id>NCT02969499</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Electroconvulsive Therapy (ECT) for Behavioural and Psychological Symptoms of Dementia (BPSD)</brief_title>
  <acronym>ECTBPSD</acronym>
  <official_title>Electroconvulsive Therapy for Behavioural and Psychological Symptoms of Dementia: A Prospective, Open-Label, Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Shores Centre for Mental Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, open-label, observational study of the efficacy and safety of ECT for&#xD;
      BPSD. There is no control or comparison group. Subjects will be compared on outcome measures&#xD;
      pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30 subjects&#xD;
      over three years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population are patients whom have a diagnosis of dementia and has behavioural and&#xD;
      psychiatric symptoms of dementia (BPSD). In this study, the participants will have already&#xD;
      been treated with antipsychotic medications as per usual practice but still do not have&#xD;
      adequate symptoms control. One of the options in current clinical practice is to consider&#xD;
      Electroconvulsive therapy (ECT) for treatment-resistant BPSD, particularly in those with&#xD;
      psychosis and/or substantial aggression. Therefore, the study involves offering ECT to these&#xD;
      individuals and measuring the patient's clinical status and severity of symptoms before and&#xD;
      after ECT treatments by using standardized rating scales. Further, background information&#xD;
      about the patient will be collected, such as their age and medical conditions.&#xD;
&#xD;
      ECT for BPSD has been done previously as reported in the medical literature. It has shown&#xD;
      significant benefit for individuals when medication does not provide enough symptomatic&#xD;
      relief. This research project is part of a larger multi-site study done in conjunction with&#xD;
      Ontario Shores academic research group in Ontario, Canada. Active recruitment began in&#xD;
      Ontario since October 2012, but our University of British Columbia (UBC) site is hoping to&#xD;
      recruit further subjects to the total of 30 participants between the two sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</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>14 Weeks</target_duration>
  <primary_outcome>
    <measure>Change in Neuropsychiatric Inventory (NPI)</measure>
    <time_frame>NPI measured 7 days pre-ECT and then 7 days after completing ECT course</time_frame>
    <description>The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD), as well as other related dementing disorders. It assesses 12 behavioral disturbances, namely delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite / eating abnormalities. The NPI assesses not only the presence, but also the frequency and severity of each behavior. The frequency is scored from 0 (never) to 4 (very frequently). The Severity is scored from 0 (none) to 3 (marked).&#xD;
The domain score is obtained by multiplying the frequency and severity scores. The total NPI score is the sum total of all of the individual domain scores (0-144).&#xD;
NPI scores 7 days pre-ECT will be compared with NPI scores 7 days after completion of ECT course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Agitation Scale (PAS)</measure>
    <time_frame>For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course</time_frame>
    <description>The PAS assesses agitation for individuals with dementia. The scale focuses on four behaviour groups: aberrant vocalizations, motor agitation, aggressiveness and resisting care.&#xD;
Each behaviour group is measured on an intensity scale ranging from 0 (not present) -4 (extremely loud screaming or yelling, highly disruptive, unable to redirect).&#xD;
The score in each behaviour group is combined for the total PAS score of maximum 16 and minimum 0.&#xD;
PAS scores 7 days pre-ECT will be compared with scores during the ECT course and at the outlined time intervals after ECT course completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion</measure>
    <time_frame>For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion</time_frame>
    <description>The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia.&#xD;
Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added to produce the total score. (maximum 38 and minimum 0) CDS scores 7 days pre-ECT will be compared with scores during the ECT course and 2 weeks after ECT course completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cornell-Brown Quality of Life Scale (CBS)</measure>
    <time_frame>For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion</time_frame>
    <description>The Cornell-Brown Quality of Life Scale measures quality of life in patients with dementia. It measures 19 items with score range of -2 to +2. Total score of -38 to +38 will be produced. This will be measured 7 days pre- vs. post-ECT (day 7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Assessment Staging of Alzheimer's Disease (FAST)</measure>
    <time_frame>For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course</time_frame>
    <description>The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the MMSE no longer can reflect changes in a meaningful clinical way.&#xD;
The FAST scale has seven stages:&#xD;
which is normal adult&#xD;
which is normal older adult&#xD;
which is early dementia&#xD;
which is mild dementia&#xD;
which is moderate dementia&#xD;
which is moderately severe dementia&#xD;
which is severe dementia&#xD;
FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined</description>
  </secondary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Dementia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with dementia as defined by DSM-IV-TR criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe BPSD: BPSD of sufficient severity that the safety of the patient or others&#xD;
             precludes the possibility of discharge to any non-hospital environment.&#xD;
&#xD;
          -  Failed &quot;standard of care for BPSD&quot;:&#xD;
&#xD;
               -  Non-pharmacological treatments (see Clinical Practice Guideline) are of&#xD;
                  insufficient benefit to allow discharge to any non-hospital environment, and&#xD;
&#xD;
               -  Pharmacological treatments are of insufficient benefit to allow discharge to any&#xD;
                  non-hospital environment. Pharmacological treatments must consist of the&#xD;
                  following prescribed specifically for BPSD:&#xD;
&#xD;
                    -  at least three atypical antipsychotic agents each for at least 4 weeks&#xD;
&#xD;
                    -  at least one of the following for at least four weeks: an antidepressant, a&#xD;
                       cholinesterase inhibitor, and/or and N-methyl-D-aspartate (NMDA) receptor&#xD;
                       antagonist (i.e. memantine).&#xD;
&#xD;
          -  Provided informed (substitute) consent to their attending psychiatrist for off-label&#xD;
             treatment of BPSD with ECT as per the Health Care (Consent) and Care Facility&#xD;
             (Admission) Act, and institutional policies and procedures.&#xD;
&#xD;
          -  Been medically-cleared for ECT by Anaesthesia as per the usual pre-ECT work-up for&#xD;
             patients admitted to the Geriatric Psychiatry Units.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that are medically unfit to undergo ECT as per consultation with an&#xD;
             anesthetist.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chan Peter</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Saint Joseph's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5T3N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital - Willow Pavilion</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ontario Shores</name>
      <address>
        <city>Whitby</city>
        <state>Ontario</state>
        <zip>L1N 5S9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>November 3, 2020</results_first_submitted>
  <results_first_submitted_qc>April 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2021</results_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Peter Y Chan</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Electroconvulsive Therapy</keyword>
  <keyword>Dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be collected and analyzed collectively and there is no plan of making the individual data available</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 5, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02969499/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Participants</title>
          <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Participants</title>
          <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74" lower_limit="66.2" upper_limit="81.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sri Lankan</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown / No information</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Educational attainment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Below Highschool</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highschool</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>University and above</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Residential setting (i.e. community vs. institutional)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Community</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Instiutional</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dementia type(s)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alzheimer's</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vascular</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Frontotemporal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Parkinson's</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed Alzheimer and Vascular</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Others</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lewy Body</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dementia severity (FAST scale described below)</title>
          <description>The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the Mini Mental State Exam (MMSE) no longer can reflect changes in a meaningful clinical way.&#xD;
The FAST scale has seven stages:&#xD;
which is normal adult&#xD;
which is normal older adult&#xD;
which is early dementia&#xD;
which is mild dementia&#xD;
which is moderate dementia&#xD;
which is moderately severe dementia&#xD;
which is severe dementia</description>
          <units>scores on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous ECT</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Neuropsychiatric Inventory (NPI)</title>
        <description>The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD), as well as other related dementing disorders. It assesses 12 behavioral disturbances, namely delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite / eating abnormalities. The NPI assesses not only the presence, but also the frequency and severity of each behavior. The frequency is scored from 0 (never) to 4 (very frequently). The Severity is scored from 0 (none) to 3 (marked).&#xD;
The domain score is obtained by multiplying the frequency and severity scores. The total NPI score is the sum total of all of the individual domain scores (0-144).&#xD;
NPI scores 7 days pre-ECT will be compared with NPI scores 7 days after completion of ECT course.</description>
        <time_frame>NPI measured 7 days pre-ECT and then 7 days after completing ECT course</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Participants</title>
            <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Neuropsychiatric Inventory (NPI)</title>
          <description>The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD), as well as other related dementing disorders. It assesses 12 behavioral disturbances, namely delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite / eating abnormalities. The NPI assesses not only the presence, but also the frequency and severity of each behavior. The frequency is scored from 0 (never) to 4 (very frequently). The Severity is scored from 0 (none) to 3 (marked).&#xD;
The domain score is obtained by multiplying the frequency and severity scores. The total NPI score is the sum total of all of the individual domain scores (0-144).&#xD;
NPI scores 7 days pre-ECT will be compared with NPI scores 7 days after completion of ECT course.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.79" spread="24.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pittsburgh Agitation Scale (PAS)</title>
        <description>The PAS assesses agitation for individuals with dementia. The scale focuses on four behaviour groups: aberrant vocalizations, motor agitation, aggressiveness and resisting care.&#xD;
Each behaviour group is measured on an intensity scale ranging from 0 (not present) -4 (extremely loud screaming or yelling, highly disruptive, unable to redirect).&#xD;
The score in each behaviour group is combined for the total PAS score of maximum 16 and minimum 0.&#xD;
PAS scores 7 days pre-ECT will be compared with scores during the ECT course and at the outlined time intervals after ECT course completion</description>
        <time_frame>For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course</time_frame>
        <population>Some participants unfortunately did not have did available for analysis due to data not collected by research team staff</population>
        <group_list>
          <group group_id="O1">
            <title>Study Participants</title>
            <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pittsburgh Agitation Scale (PAS)</title>
          <description>The PAS assesses agitation for individuals with dementia. The scale focuses on four behaviour groups: aberrant vocalizations, motor agitation, aggressiveness and resisting care.&#xD;
Each behaviour group is measured on an intensity scale ranging from 0 (not present) -4 (extremely loud screaming or yelling, highly disruptive, unable to redirect).&#xD;
The score in each behaviour group is combined for the total PAS score of maximum 16 and minimum 0.&#xD;
PAS scores 7 days pre-ECT will be compared with scores during the ECT course and at the outlined time intervals after ECT course completion</description>
          <population>Some participants unfortunately did not have did available for analysis due to data not collected by research team staff</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.83" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion</title>
        <description>The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia.&#xD;
Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added to produce the total score. (maximum 38 and minimum 0) CDS scores 7 days pre-ECT will be compared with scores during the ECT course and 2 weeks after ECT course completion</description>
        <time_frame>For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion</time_frame>
        <population>Some participants unfortunately did not have did available for analysis due to data not collected by research team staff</population>
        <group_list>
          <group group_id="O1">
            <title>Study Participants</title>
            <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion</title>
          <description>The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia.&#xD;
Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added to produce the total score. (maximum 38 and minimum 0) CDS scores 7 days pre-ECT will be compared with scores during the ECT course and 2 weeks after ECT course completion</description>
          <population>Some participants unfortunately did not have did available for analysis due to data not collected by research team staff</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.26" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cornell-Brown Quality of Life Scale (CBS)</title>
        <description>The Cornell-Brown Quality of Life Scale measures quality of life in patients with dementia. It measures 19 items with score range of -2 to +2. Total score of -38 to +38 will be produced. This will be measured 7 days pre- vs. post-ECT (day 7)</description>
        <time_frame>For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion</time_frame>
        <population>Some participants unfortunately did not have did available for analysis due to data not collected by research team staff</population>
        <group_list>
          <group group_id="O1">
            <title>Study Participants</title>
            <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cornell-Brown Quality of Life Scale (CBS)</title>
          <description>The Cornell-Brown Quality of Life Scale measures quality of life in patients with dementia. It measures 19 items with score range of -2 to +2. Total score of -38 to +38 will be produced. This will be measured 7 days pre- vs. post-ECT (day 7)</description>
          <population>Some participants unfortunately did not have did available for analysis due to data not collected by research team staff</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.26" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Functional Assessment Staging of Alzheimer's Disease (FAST)</title>
        <description>The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the MMSE no longer can reflect changes in a meaningful clinical way.&#xD;
The FAST scale has seven stages:&#xD;
which is normal adult&#xD;
which is normal older adult&#xD;
which is early dementia&#xD;
which is mild dementia&#xD;
which is moderate dementia&#xD;
which is moderately severe dementia&#xD;
which is severe dementia&#xD;
FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined</description>
        <time_frame>For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Participants</title>
            <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Functional Assessment Staging of Alzheimer's Disease (FAST)</title>
          <description>The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the MMSE no longer can reflect changes in a meaningful clinical way.&#xD;
The FAST scale has seven stages:&#xD;
which is normal adult&#xD;
which is normal older adult&#xD;
which is early dementia&#xD;
which is mild dementia&#xD;
which is moderate dementia&#xD;
which is moderately severe dementia&#xD;
which is severe dementia&#xD;
FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse effects are collected by using the Columbia ECT subjective side effect schedule. This 32 item scale will be administered at baseline (7 days pre-ECT) and in the afternoon following the 1st, 4th and 8th treatments and in the week following the course of ECT (post-treatment day 7).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Participants</title>
          <description>Participants recruited require a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (APA, 2000) and were referred to ECT for treatment of agitation and/or aggression. They have failed non-pharmacological treatments and failed at least 2 psychotropic medications at adequate dose and duration or stopped due to adverse effects. They have to be cleared by an anesthetist as being medically stable to receive ECT. Patients are excluded from the study if their temporary substitute decision make did not consent to participation in this study or they are medically unstable to receive ECT as determined by an anesthetist.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Patient passed away 2 days after their last ECT due to pneumonia but it was felt that was unlikely to be directly related to ECT treatment as the patient was frail</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension/Bradycardia</sub_title>
                <description>One participant had a transient bout of hypotension and bradycardia after an ECT treatment</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <description>Two participants manifested agitation/restlessness after ECT, and it was not clear if this represented an exacerbation of their (Neuro-Psychiatric Symptoms) NPS or if there was concurrent transient post-ECT delirium.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <description>Two participants had ECT held temporarily due to increased confusion when they developed a urinary tract infection. The delirium in each was not deemed to be related to ECT.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Retrospective design, medication use not controlled for.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Simon Woo</name_or_title>
      <organization>University of British Columbia</organization>
      <phone>604-520-4662</phone>
      <email>simon.woo@fraserhealth.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02969499
org study id: H15-02351
nct id: NCT02969499
lead sponsor: 
collaborator: 
has dmc: No
This is a prospective, open-label, observational study of the efficacy and safety of ECT for
      BPSD. There is no control or comparison group. Subjects will be compared on outcome measures
      pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30 subjects
      over three years
The study population are patients whom have a diagnosis of dementia and has behavioural and
      psychiatric symptoms of dementia (BPSD). In this study, the participants will have already
      been treated with antipsychotic medications as per usual practice but still do not have
      adequate symptoms control. One of the options in current clinical practice is to consider
      Electroconvulsive therapy (ECT) for treatment-resistant BPSD, particularly in those with
      psychosis and/or substantial aggression. Therefore, the study involves offering ECT to these
      individuals and measuring the patient's clinical status and severity of symptoms before and
      after ECT treatments by using standardized rating scales. Further, background information
      about the patient will be collected, such as their age and medical conditions.

      ECT for BPSD has been done previously as reported in the medical literature. It has shown
      significant benefit for individuals when medication does not provide enough symptomatic
      relief. This research project is part of a larger multi-site study done in conjunction with
      Ontario Shores academic research group in Ontario, Canada. Active recruitment began in
      Ontario since October 2012, but our University of British Columbia (UBC) site is hoping to
      recruit further subjects to the total of 30 participants between the two sites.
observational model: Case-Only
time perspective: Prospective
measure: Change in Neuropsychiatric Inventory (NPI)
time frame: NPI measured 7 days pre-ECT and then 7 days after completing ECT course
description: The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD), as well as other related dementing disorders. It assesses 12 behavioral disturbances, namely delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, night-time behavior disturbances, and appetite / eating abnormalities. The NPI assesses not only the presence, but also the frequency and severity of each behavior. The frequency is scored from 0 (never) to 4 (very frequently). The Severity is scored from 0 (none) to 3 (marked).
The domain score is obtained by multiplying the frequency and severity scores. The total NPI score is the sum total of all of the individual domain scores (0-144).
NPI scores 7 days pre-ECT will be compared with NPI scores 7 days after completion of ECT course.
measure: Change in Pittsburgh Agitation Scale (PAS)
time frame: For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course
description: The PAS assesses agitation for individuals with dementia. The scale focuses on four behaviour groups: aberrant vocalizations, motor agitation, aggressiveness and resisting care.
Each behaviour group is measured on an intensity scale ranging from 0 (not present) -4 (extremely loud screaming or yelling, highly disruptive, unable to redirect).
The score in each behaviour group is combined for the total PAS score of maximum 16 and minimum 0.
PAS scores 7 days pre-ECT will be compared with scores during the ECT course and at the outlined time intervals after ECT course completion
measure: Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion
time frame: For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion
description: The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia.
Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added to produce the total score. (maximum 38 and minimum 0) CDS scores 7 days pre-ECT will be compared with scores during the ECT course and 2 weeks after ECT course completion
measure: Change in Cornell-Brown Quality of Life Scale (CBS)
time frame: For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion
description: The Cornell-Brown Quality of Life Scale measures quality of life in patients with dementia. It measures 19 items with score range of -2 to +2. Total score of -38 to +38 will be produced. This will be measured 7 days pre- vs. post-ECT (day 7)
measure: Change in Functional Assessment Staging of Alzheimer's Disease (FAST)
time frame: For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course
description: The FAST scale is a functional scale designed to evaluate patients at the more moderate-severe stages of dementia when the MMSE no longer can reflect changes in a meaningful clinical way.
The FAST scale has seven stages:
which is normal adult
which is normal older adult
which is early dementia
which is mild dementia
which is moderate dementia
which is moderately severe dementia
which is severe dementia
FAST score 7 days pre-ECT will be compared with score during ECT course and up to 8 weeks after course completion as outlined
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Chan Peter
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Peter Y Chan
investigator title: Clinical Professor
mesh term: Dementia
sharing ipd: No
ipd description: Data will be collected and analyzed collectively and there is no plan of making the individual data available
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Retrospective design, medication use not controlled for.
point of contact: 