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

Pine Rest Christian Mental Health Services

Status: Completed

Conditions: Agitation; Aggression; Dementia

Treatments: Other: Standard Care (Non-ECT group); Other: ECT treatment

Study type: Observational

Funder types: Other

Identifiers

NCT01856010

SM10-1221-01

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

23 participants in 2 patient groups

ECT Treatment

Description:

Those who were referred for ECT treatment for behavior refractory to standard care and who opted to undergo ECT treatment

Treatment:

Other: ECT treatment

Standard Care (Non-ECT Group)

Description:

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.

Treatment:

Other: Standard Care (Non-ECT group)