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DementiaNCT01856010

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

An observational study of Dementia and Aggression, run by Pine Rest Christian Mental Health Services at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Dementia, Aggression, Agitation
What is being tested?
ECT treatment
How many people
23 participants
Where
2 sitesUnited States
Study dates
Mar 2011to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Older Adult Unit of Pine Rest Christian Mental Health Services

    Grand Rapids, Michigan, 49548

Other trials in United States

About this study

Official title: Short-term Efficacy and Cognitive Side Effects of Acute Electroconvulsive Therapy (ECT) 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.

Being tested
ECT treatment, Standard Care (Non-ECT group)
Keywords
Dementia, Aggression, Agitation
Medical subject headings
Dementia, Aggression, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECT treatmentOther

    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.

Study groups in NCT01856010
Study groupRoleWhat they receive
ECT TreatmentThose who were referred for ECT treatment for behavior refractory to standard care and who opted to undergo ECT treatment
Receives: 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.
Receives: Other: Standard Care (Non-ECT group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in baseline of the Cohen-Mansfield Agitation Inventory Short Version (CMAI)

    Measures agitation or aggression outcomes - completed by primary caregiver

    Measured: 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)

  1. 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

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

  2. Cornell Scale for Depression in Dementia (CSDD)

    Assesses the presence and severity of depressive symptoms - completed by primary caregiver

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

  3. Neuropsychiatric Inventory Nursing Home Version (NPI)

    Measures neuropsychiatric symptoms outcomes and caregiver burden - completed by primary caregiver

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

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

    Indicates severity of dementia with agitation/aggression at the time of assessment - completed by physician

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

  5. Mini Mental Status Examination (MMSE)

    Measures cognition - primary caregiver completes with subject

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

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

    Measures concentration, attention and memory - primary caregiver completes with subject

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

  7. Geriatric Evaluation of Mental Status (GEMS)

    Measures list learning tasks to assess verbal memory outcome - primary caregiver completes with subject

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

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

    Measures functional ability outcomes - completed by primary caregiver

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

  9. Use of Psychoactive "As Needed" (PRN) Medication

    Records use of PRN medication for agitation/aggression

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

  10. Delirium and/or adverse reactions to ECT or medication

    Assessed by treating physician

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2013 (estimated)
  2. Study startMar 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856010
Sponsor's protocol ID
SM10-1221-01
Status last verified
Feb 2015
First submitted
13 Nov 2012
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22143072

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia and Aggression, run by Pine Rest Christian Mental Health Services at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01856010, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.

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