NCT01856010

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Pine Rest Christian Mental Health Services · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-05-17
• Last updated: 2015-02-16

Locations

2 sites across 1 country: United States