Clinical trial NCT02969499: Safety and Efficacy of Electroconvulsive Therapy (ECT) for Behavioural and Psychological Symptoms of Dementia (BPSD)
Official title: Electroconvulsive Therapy for Behavioural and Psychological Symptoms of Dementia: A Prospective, Open-Label, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Electroconvulsive Therapy
Dementia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Ontario Shores Centre for Mental Health Sciences
First posted: 2016-11-21
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dementia as defined by DSM-IV-TR criteria

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

Detailed 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.

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.

Primary outcomes:
measure: Change in Neuropsychiatric Inventory (NPI)
timeFrame: NPI measured 7 days pre-ECT and then 7 days after completing ECT course
Secondary outcomes:
measure: Change in Pittsburgh Agitation Scale (PAS)
timeFrame: For the reported value here, PAS measured 7 days pre-ECT is compared with 8 weeks after ECT course
measure: Change in Cornell Depression Scale (CDS) Before ECT, During Treatment Course and After Treatment Completion
timeFrame: For outcome report here: CDS measured 7 days pre-ECT is compared to 2 weeks after ECT course completion
measure: Change in Cornell-Brown Quality of Life Scale (CBS)
timeFrame: For result reported here, CBS measured 7 days pre-ECT is compared to 7 days post ECT course completion
measure: Change in Functional Assessment Staging of Alzheimer's Disease (FAST)
timeFrame: For outcome reported here, FAST measured 7 days pre-ECT is compared to 8 weeks after completion of ECT course
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Mount Saint Joseph's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Willow Pavilion
state: British Columbia
city: Whitby
country: Canada
facility: Ontario Shores
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Chan Peter
role: PRINCIPAL_INVESTIGATOR
References: