Short-term Efficacy and Cognitive Side Effects of Acute Electroconvulsive Therapy (ECT) for Agitation and Aggression in Dementia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dementia
- Sponsor
- Pine Rest Christian Mental Health Services
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Agitation/aggression is one of the most common and serious behavioral complications of dementia. If the behavior is refractory to standard care (behavior approaches and off label use of psychotropic medications), other evidence based treatment options are not currently available. Retrospective reviews and preliminary studies have indicated Electroconvulsive Therapy (ECT) may be a safe, effective intervention in this patient population. This study will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition, mood and psychosis for patients referred for ECT who accept this intervention vs. those patients referred for ECT but decline this intervention (i.e. standard care controls). It will also assess adverse events, activities of daily living and caregiver burden during study participation. The hypothesis is that subjects with dementia related aggression/agitation who receive ECT will show significantly greater reductions in these behaviors than subjects who do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean Hospital (Massachusetts) to answer this question. To our knowledge, this is the first prospective study to examine whether patients receiving ECT or standard care differ in reduction of aggression and agitation symptom severity and changes in cognition pre- and post- treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients age 50 years or older from the Older Adult Unit of Pine Rest Christian Mental Health Services or Geriatric Unit at McLean Hospital
- •Diagnosis of Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Criteria
- •Mini Mental Status Examination (MMSE) score of 16 or greater
- •Fluent in English
- •Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): a score of 4 or greater on at least one aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occuring in frequency of 2 and 1 at frequency of
- •A therapeutic decision will have already been made by the treating psychiatrist in consultation with the ECT team to use ECT treatment for agitation and aggression associated with dementia, with or without depression/mania. Patients will be included in the ECT treatment group if their legal representative consents to ECT treatment. Patients whose legal representative does not consent to ECT treatment will be included in the Standard Care (Non-ECT) treatment group.
- •Informed Consent signed by authorized legal guardian and assent given by the participant
- •Signed Authorization for Release of Healthcare Information by authorized legal guardian
Exclusion Criteria
- •Current diagnosis of co-morbid delirium according to DSM-IV upon study entry
- •ECT treatment within 90 days prior to study enrollment
Outcomes
Primary Outcomes
Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI)
Time Frame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
Measures agitation or aggression outcomes - completed by primary caregiver
Secondary Outcomes
- Severe Impairment Battery (SIB)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Neuropsychiatric Inventory Nursing Home Version (NPI)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Clinical Global Impression Scale: Severity (CGI-S)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Mini Mental Status Examination (MMSE)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span (forwards and backwards)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Cornell Scale for Depression in Dementia (CSDD)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Use of Psychoactive "As Needed" (PRN) Medication(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Geriatric Evaluation of Mental Status (GEMS)(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)
- Delirium and/or adverse reactions to ECT or medication(Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks)