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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856010
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : February 16, 2015
Sponsor:
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
Pine Rest Christian Mental Health Services

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
Dementia Aggression Agitation Other: ECT treatment Other: Standard Care (Non-ECT group)

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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 : March 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort 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.




Primary Outcome Measures :
  1. Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI) [ Time Frame: 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 :
  1. Severe Impairment Battery (SIB) [ Time Frame: 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

  2. Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: 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

  3. Neuropsychiatric Inventory Nursing Home Version (NPI) [ Time Frame: 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

  4. Clinical Global Impression Scale: Severity (CGI-S) [ Time Frame: 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

  5. Mini Mental Status Examination (MMSE) [ Time Frame: 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

  6. Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span (forwards and backwards) [ Time Frame: 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

  7. Geriatric Evaluation of Mental Status (GEMS) [ Time Frame: 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

  8. Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) [ Time Frame: 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

  9. Use of Psychoactive "As Needed" (PRN) Medication [ Time Frame: 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

  10. Delirium and/or adverse reactions to ECT or medication [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856010


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
United States, Michigan
Older Adult Unit of Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, United States, 49548
Sponsors and Collaborators
Pine Rest Christian Mental Health Services
Mclean Hospital
Investigators
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Principal Investigator: Jack Mahdasian, MD Pine Rest Christian Mental Health Services
Principal Investigator: Brent P Forester, MD Mclean Hospital
Additional Information:
Publications of Results:
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Responsible Party: Pine Rest Christian Mental Health Services
ClinicalTrials.gov Identifier: NCT01856010    
Other Study ID Numbers: SM10-1221-01
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Pine Rest Christian Mental Health Services:
Dementia
Aggression
Agitation
Additional relevant MeSH terms:
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Dementia
Psychomotor Agitation
Aggression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Behavioral Symptoms