Clinical Trial: Study of Electroconvulsive Therapy (ECT) Treatment for Agitation and Aggression in Dementia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Short-term Efficacy and Cognitive Side Effects of Acute Electroconvulsive Therapy (ECT) for Agitation and Aggression in Dementia

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.

Detailed Summary:
Sponsor: Pine Rest Christian Mental Health Services

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Severe Impairment Battery (SIB) [ 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 ]
    Gathers direct performance-based data from the subject with dementia on a wide variety of low-level tasks that take into account the specific behavioral and cognitive deficits associated with severe dementia
  • Cornell Scale for Depression in Dementia (CSDD) [ 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 ]
    Assesses the presence and severity of depressive symptoms - completed by primary caregiver
  • Neuropsychiatric Inventory Nursing Home Version (NPI) [ 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 neuropsychiatric symptoms outcomes and caregiver burden - completed by primary caregiver
  • Clinical Global Impression Scale: Severity (CGI-S) [ 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 ]
    Indicates severity of dementia with agitation/aggression at the time of assessment - completed by physician
  • Mini Mental Status Examination (MMSE) [ 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 cognition - primary caregiver completes with subject
  • Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span (forwards and backwards) [ 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 concentration, attention and memory - primary caregiver completes with subject
  • Geriatric Evaluation of Mental Status (GEMS) [ 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 list learning tasks to assess verbal memory outcome - primary caregiver completes with subject
  • Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) [ 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 functional ability outcomes - completed by primary caregiver
  • Use of Psychoactive "As Needed" (PRN) Medication [ 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 ]
    Records use of PRN medication for agitation/aggression
  • Delirium and/or adverse reactions to ECT or medication [ 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 ]
    Assessed by treating physician


Original Secondary Outcome: Same as current

Information By: Pine Rest Christian Mental Health Services

Dates:
Date Received: November 13, 2012
Date Started: March 2011
Date Completion:
Last Updated: February 13, 2015
Last Verified: February 2015