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DementiaECTBPSDNCT02969499

Safety and Efficacy of Electroconvulsive Therapy (ECT) for Behavioural and Psychological Symptoms of Dementia (BPSD)

An observational study of Dementia, run by University of British Columbia at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Dementia
How many people
33 participants
Where
3 sitesCanada
Study dates
Nov 2016to May 2020
How long will I take part?
14 Weeks
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with dementia as defined by DSM-IV-TR criteria

Who may be able to join

  • Severe BPSD: BPSD of sufficient severity that the safety of the patient or others precludes the possibility of discharge to any non-hospital environment.
  • Failed "standard of care for BPSD":
  • Non-pharmacological treatments (see Clinical Practice Guideline) are of insufficient benefit to allow discharge to any non-hospital environment, and
  • Pharmacological treatments are of insufficient benefit to allow discharge to any non-hospital environment. Pharmacological treatments must consist of the following prescribed specifically for BPSD:
  • at least three atypical antipsychotic agents each for at least 4 weeks
  • at least one of the following for at least four weeks: an antidepressant, a cholinesterase inhibitor, and/or and N-methyl-D-aspartate (NMDA) receptor antagonist (i.e. memantine).
  • Provided informed (substitute) consent to their attending psychiatrist for off-label treatment of BPSD with ECT as per the Health Care (Consent) and Care Facility (Admission) Act, and institutional policies and procedures.
  • Been medically-cleared for ECT by Anaesthesia as per the usual pre-ECT work-up for patients admitted to the Geriatric Psychiatry Units.

Who cannot join

  • Patients that are medically unfit to undergo ECT as per consultation with an anesthetist.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Mount Saint Joseph's Hospital

    Vancouver, British Columbia, V5T3N4

  • Vancouver General Hospital - Willow Pavilion

    Vancouver, British Columbia, V5Z 1M9

  • Ontario Shores

    Whitby, Ontario, L1N 5S9

Other trials in Canada

About this study

Official title: Electroconvulsive Therapy for Behavioural and Psychological Symptoms of Dementia: A Prospective, Open-Label, Observational Study

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

Read the detailed description

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.

Conditions
Dementia
Keywords
Electroconvulsive Therapy, Dementia
Medical subject headings
Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Neuropsychiatric Inventory (NPI)

    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.

    Measured: NPI measured 7 days pre-ECT and then 7 days after completing ECT course

Secondary outcomes (4)

  1. Change in Pittsburgh Agitation Scale (PAS)

    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

    Measured: For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course

  2. Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion

    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

    Measured: For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion

  3. Change in Cornell-Brown Quality of Life Scale (CBS)

    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)

    Measured: For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion

  4. Change in Functional Assessment Staging of Alzheimer's Disease (FAST)

    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:

    1. which is normal adult
    2. which is normal older adult
    3. which is early dementia
    4. which is mild dementia
    5. which is moderate dementia
    6. which is moderately severe dementia
    7. 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

    Measured: For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionMay 2020
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
33 participants (actual)
Target duration
14 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969499
Sponsor's protocol ID
H15-02351
Acronym
ECTBPSD
Status last verified
Apr 2021
First submitted
1 Nov 2016
Last updated
6 May 2021
Data monitoring committee
No
Individual data sharing
No: Data will be collected and analyzed collectively and there is no plan of making the individual data available

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia, run by University of British Columbia at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Neuropsychiatric Inventory (NPI) (time frame: NPI measured 7 days pre-ECT and then 7 days after completing ECT course). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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