Skip to main content
OpenTrials
Completed

NCT Number: NCT01856010

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital, Belmont, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pine Rest Christian Mental Health Services

Other

Collaborators

  • Mclean Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 17, 2013
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.