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

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

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.

Study Overview

• Status: Completed
• Conditions: Aggression; Dementia; Agitation
• Intervention / Treatment: Other: ECT treatment; Other: Standard Care (Non-ECT group)

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49548
      • Older Adult Unit of Pine Rest Christian Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals age 50 or older that have been diagnosed with dementia and associated agitation and aggression and have already been referred for ECT.

Description

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 3.
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECT Treatment; Those who were referred for ECT treatment for behavior refractory to standard care and who opted to undergo ECT treatment	Other: ECT treatment; The decision to administer ECT treatment will have already been made before the subject is approached about study participation. Only individuals who were referred for ECT due to behavior refractory to standard care will be eligible to participate. If they decide to do ECT treatment, they are in the ECT group.
Standard Care (Non-ECT Group); Those who were referred for ECT treatment for behavior refractory to standard care, but who opted to not undergo ECT treatment and continue with standard care.	Other: Standard Care (Non-ECT group); The decision to administer ECT treatment will have already been made before the subject is approached about study participation. Only individuals who were referred for ECT due to behavior refractory to standard care will be eligible to participate. If they decide not to do ECT treatment and continue with standard care, they are in the Standard Care (Non-ECT) Group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI)	Measures agitation or aggression outcomes - completed by primary caregiver	Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Impairment Battery (SIB)	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	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)	Assesses the presence and severity of depressive symptoms - completed by primary caregiver	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)	Measures neuropsychiatric symptoms outcomes and caregiver burden - completed by primary caregiver	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)	Indicates severity of dementia with agitation/aggression at the time of assessment - completed by physician	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)	Measures cognition - primary caregiver completes with subject	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)	Measures concentration, attention and memory - primary caregiver completes with subject	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)	Measures list learning tasks to assess verbal memory outcome - primary caregiver completes with subject	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)	Measures functional ability outcomes - completed by primary caregiver	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	Records use of PRN medication for agitation/aggression	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	Assessed by treating physician	Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

Collaborators and Investigators

• Sponsor: Pine Rest Christian Mental Health Services
• Collaborators: Mclean Hospital
• Investigators: Principal Investigator: Brent P Forester, MD, McLean Hospital; Principal Investigator: Jack Mahdasian, MD, Pine Rest Christian Mental Health Services

Publications and helpful links

General Publications

• Ujkaj M, Davidoff DA, Seiner SJ, Ellison JM, Harper DG, Forester BP. Safety and efficacy of electroconvulsive therapy for the treatment of agitation and aggression in patients with dementia. Am J Geriatr Psychiatry. 2012 Jan;20(1):61-72. doi: 10.1097/JGP.0b013e3182051bbc.

Helpful Links

• Results publication for this study - 16/MAY/2014

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Estimate): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 13, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Dementia; Aggression; Agitation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Aggression; Psychomotor Agitation; Dementia
• Other Study ID Numbers: SM10-1221-01