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

February 13, 2015 updated by: Pine Rest Christian Mental Health Services

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Mclean Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49548
        • Older Adult Unit of Pine Rest Christian Mental Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
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)
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
Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
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
Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
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
Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
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
Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
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
Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks
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
Participants will be followed on the average of 5 weeks (+/- 1 week) since ECT treatment is generally administered 3x per week for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pine Rest Christian Mental Health Services

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mclean Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brent P Forester, MD, Mclean Hospital
  • Principal Investigator: Jack Mahdasian, MD, Pine Rest Christian Mental Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SM10-1221-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings