Status:
COMPLETED
Study of Electroconvulsive Therapy (ECT) Treatment for Agitation and Aggression in Dementia
Lead Sponsor:
Pine Rest Christian Mental Health Services
Collaborating Sponsors:
Mclean Hospital
Conditions:
Dementia
Aggression
Eligibility:
All Genders
50+ years
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 m...
Eligibility Criteria
Inclusion
- 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
- Current diagnosis of co-morbid delirium according to DSM-IV upon study entry
- ECT treatment within 90 days prior to study enrollment
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01856010
Start Date
March 1 2011
End Date
October 1 2012
Last Update
February 16 2015
Active Locations (2)
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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