Trial Outcomes & Findings for Safety and Efficacy of Electroconvulsive Therapy (ECT) for Behavioural and Psychological Symptoms of Dementia (BPSD) (NCT NCT02969499)

Last Updated: 2021-05-06

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

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

Results posted on

2021-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Study Participants 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.
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Participants n=33 Participants 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.
Age, Continuous	74 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	22 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Sri Lankan	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown / No information	9 Participants n=5 Participants
Educational attainment Below Highschool	3 Participants n=5 Participants
Educational attainment Highschool	11 Participants n=5 Participants
Educational attainment College	1 Participants n=5 Participants
Educational attainment University and above	6 Participants n=5 Participants
Educational attainment Unknown	12 Participants n=5 Participants
Residential setting (i.e. community vs. institutional) Community	2 Participants n=5 Participants
Residential setting (i.e. community vs. institutional) Instiutional	31 Participants n=5 Participants
Dementia type(s) Alzheimer's	14 Participants n=5 Participants
Dementia type(s) Vascular	4 Participants n=5 Participants
Dementia type(s) Frontotemporal	5 Participants n=5 Participants
Dementia type(s) Parkinson's	1 Participants n=5 Participants
Dementia type(s) Mixed Alzheimer and Vascular	3 Participants n=5 Participants
Dementia type(s) Mixed	3 Participants n=5 Participants
Dementia type(s) Others	2 Participants n=5 Participants
Dementia type(s) Lewy Body	1 Participants n=5 Participants
Dementia severity (FAST scale described below)	6.5 scores on scale STANDARD_DEVIATION 0.54 • n=5 Participants
Previous ECT Yes	3 Participants n=5 Participants
Previous ECT No	30 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Study Participants n=33 Participants 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.
Change in Neuropsychiatric Inventory (NPI)	-32.79 units on a scale Standard Deviation 24.72

SECONDARY outcome

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

Population: Some participants unfortunately did not have did available for analysis due to data not collected by research team staff

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

Outcome measures

Outcome measures
Measure	Study Participants n=27 Participants 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.
Change in Pittsburgh Agitation Scale (PAS)	-4.83 units on a scale Standard Deviation 1.14

SECONDARY outcome

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

Population: Some participants unfortunately did not have did available for analysis due to data not collected by research team staff

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

Outcome measures

Outcome measures
Measure	Study Participants n=31 Participants 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.
Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion	-6.26 units on a scale Standard Deviation 0.95

SECONDARY outcome

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

Population: Some participants unfortunately did not have did available for analysis due to data not collected by research team staff

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)

Outcome measures

Outcome measures
Measure	Study Participants n=31 Participants 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.
Change in Cornell-Brown Quality of Life Scale (CBS)	6.26 units on a scale Standard Deviation 0.95

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Study Participants n=33 Participants 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.
Change in Functional Assessment Staging of Alzheimer's Disease (FAST)	0.12 units on a scale Standard Deviation 0.6

Adverse Events

Study Participants

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Study Participants n=33 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Death	3.0% 1/33 • Number of events 1 • 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).

Other adverse events

Other adverse events
Measure	Study Participants n=33 participants at risk 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.
Renal and urinary disorders Delirium	6.1% 2/33 • Number of events 2 • 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).
Nervous system disorders Agitation	6.1% 2/33 • Number of events 2 • 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).
Cardiac disorders Hypotension/Bradycardia	3.0% 1/33 • Number of events 1 • 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).

Additional Information

Dr. Simon Woo

University of British Columbia

Phone: 604-520-4662

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place