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

Sponsor

Pine Rest Christian Mental Health Services (Other)

Overall Status

Completed

CT.gov ID

NCT01856010

Collaborator

Mclean Hospital (Other)

Enrollment

Locations

19.1

Duration (Months)

11.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Aggression Agitation	Other: ECT treatment Other: Standard Care (Non-ECT group)

Study Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	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.

Arm

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)

Outcome Measures

Primary Outcome Measures

Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI) [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 Outcome Measures

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]
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) [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) [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) [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) [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) [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) [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) [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McLean Hospital	Belmont	Massachusetts	United States	02478
2	Older Adult Unit of Pine Rest Christian Mental Health Services	Grand Rapids	Michigan	United States	49548