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

University of British Columbia

Status: Completed

Conditions: Dementia

Study type: Observational

Funder types: Other

Identifiers

NCT02969499

H15-02351

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design