Clinical trial NCT01856010: Study of Electroconvulsive Therapy (ECT) Treatment for Agitation and Aggression in Dementia
Official title: Short-term Efficacy and Cognitive Side Effects of Acute Electroconvulsive Therapy (ECT) for Agitation and Aggression in Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Aggression
Agitation
Keywords: Dementia
Aggression
Agitation
Lead sponsor: Pine Rest Christian Mental Health Services
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
First posted: 2013-05-17
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI)
timeFrame: 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 outcomes:
measure: Severe Impairment Battery (SIB)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Neuropsychiatric Inventory Nursing Home Version (NPI)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Clinical Global Impression Scale: Severity (CGI-S)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Mini Mental Status Examination (MMSE)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span (forwards and backwards)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Geriatric Evaluation of Mental Status (GEMS)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Use of Psychoactive "As Needed" (PRN) Medication
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
measure: Delirium and/or adverse reactions to ECT or medication
timeFrame: Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Older Adult Unit of Pine Rest Christian Mental Health Services
state: Michigan
Study officials:
affiliation: Pine Rest Christian Mental Health Services
name: Jack Mahdasian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mclean Hospital
name: Brent P Forester, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.