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

Dementia Clinical Trial

— ECTBPSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969499
• Other study ID #: H15-02351
• Status: Completed
• Start date: November 2016
• Est. completion date: May 2020

Study information

• Verified date: April 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
Canada	Mount Saint Joseph's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital - Willow Pavilion	Vancouver	British Columbia
Canada	Ontario Shores	Whitby	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Ontario Shores Centre for Mental Health Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	NPI measured 7 days pre-ECT and then 7 days after completing ECT course
Secondary	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	For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course
Secondary	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	For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion
Secondary	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)	For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion
Secondary	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: 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	For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course