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

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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

Tracking Information
First Submitted Date November 13, 2012
First Posted Date May 17, 2013
Last Update Posted Date February 16, 2015
Study Start Date March 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2013)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Electroconvulsive Therapy (ECT) Treatment for Agitation and Aggression in Dementia
Official Title Short-term Efficacy and Cognitive Side Effects of Acute Electroconvulsive Therapy (ECT) for Agitation and Aggression in Dementia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Dementia
  • Aggression
  • Agitation
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • ECT Treatment
    Those who were referred for ECT treatment for behavior refractory to standard care and who opted to undergo ECT treatment
    Intervention: 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.
    Intervention: Other: Standard Care (Non-ECT group)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 14, 2013)
23
Original Actual Enrollment Same as current
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01856010
Other Study ID Numbers SM10-1221-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Pine Rest Christian Mental Health Services
Original Responsible Party Same as current
Current Study Sponsor Pine Rest Christian Mental Health Services
Original Study Sponsor Same as current
Collaborators Mclean Hospital
Investigators
Principal Investigator: Jack Mahdasian, MD Pine Rest Christian Mental Health Services
Principal Investigator: Brent P Forester, MD Mclean Hospital
PRS Account Pine Rest Christian Mental Health Services
Verification Date February 2015