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

NCT02969499 | Completed Results

• 1 other identifier: H15-02351
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Dementia

Keywords

Electroconvulsive Therapy; Dementia

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Change in Pittsburgh Agitation Scale (PAS)

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

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

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

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

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

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dementia as defined by DSM-IV-TR criteria

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Ontario Shores Centre for Mental Health Sciences: collaborator

Study Sites (3)

Mount Saint Joseph's Hospital

Vancouver, British Columbia, V5T3N4, Canada

Location

Vancouver General Hospital - Willow Pavilion

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Ontario Shores

Whitby, Ontario, L1N 5S9, Canada

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Retrospective design, medication use not controlled for.

Results Point of Contact

• Title: Dr. Simon Woo
• Organization: University of British Columbia

simon.woo@fraserhealth.ca

604-520-4662

Study Officials

• Chan Peter

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)