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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856010
• Other study ID #: SM10-1221-01
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: February 13, 2015
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2015
• Source: Pine Rest Christian Mental Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aggression
• Agitation
• Dementia
• Psychomotor Agitation

Intervention

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)
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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts
United States	Older Adult Unit of Pine Rest Christian Mental Health Services	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Pine Rest Christian Mental Health Services	Mclean Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes

External Links

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