N/A
N=33
Safety and Efficacy of Electroconvulsive Therapy (ECT) for Behavioural and Psychological Symptoms of Dementia (BPSD)
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT02969499 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
May 2021
Primary outcome: Primary: Change in Neuropsychiatric Inventory (NPI) — -32.79 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neuropsychiatric Inventory (NPI) |
-32.79 | — |
| SECONDARY Change in Pittsburgh Agitation Scale (PAS) |
-4.83 | — |
| SECONDARY Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion |
-6.26 | — |
| SECONDARY Change in Cornell-Brown Quality of Life Scale (CBS) |
6.26 | — |
| SECONDARY Change in Functional Assessment Staging of Alzheimer's Disease (FAST) |
0.12 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02969499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.