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

NCT01856010 | Completed

• 1 other identifier: SM10-1221-01
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia; Aggression; Agitation

Keywords

Dementia; Aggression; Agitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Severe Impairment Battery (SIB)

  Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

• Cornell Scale for Depression in Dementia (CSDD)

  Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

• Neuropsychiatric Inventory Nursing Home Version (NPI)

  Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

• Clinical Global Impression Scale: Severity (CGI-S)

  Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

• Mini Mental Status Examination (MMSE)

  Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

Study Arms (2)

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

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)

Interventions

ECT treatment OTHER

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.

ECT Treatment

Standard Care (Non-ECT group) OTHER

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.

Standard Care (Non-ECT Group)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Current diagnosis of co-morbid delirium according to DSM-IV upon study entry
• ECT treatment within 90 days prior to study enrollment

Sponsors & Collaborators

• Pine Rest Christian Mental Health Services: lead
• Mclean Hospital: collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Older Adult Unit of Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, 49548, United States

Location

Related 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.0b013e3182051bbc.

  PMID: 22143072 RESULT

MeSH Terms

Conditions

Dementia; Aggression; Psychomotor Agitation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jack Mahdasian, MD

  Pine Rest Christian Mental Health Services

  PRINCIPAL INVESTIGATOR

• Brent P Forester, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: May 17, 2013
• Study Start: March 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

US (2)