1. A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT).
- Author
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Sahlem GL, McCall WV, Short EB, Rosenquist PB, Fox JB, Youssef NA, Manett AJ, Kerns SE, Dancy MM, McCloud L, George MS, and Sackeim HA
- Subjects
- Adult, Depressive Disorder diagnosis, Electroconvulsive Therapy adverse effects, Female, Heart Rate physiology, Humans, Male, Middle Aged, Seizures diagnosis, Seizures etiology, Treatment Outcome, Depressive Disorder physiopathology, Depressive Disorder therapy, Electroconvulsive Therapy methods, Prefrontal Cortex physiology, Seizures physiopathology
- Abstract
Background: Focal Electrically-Administered Seizure Therapy (FEAST) is a form of electroconvulsive therapy (ECT) that spatially focuses the electrical stimulus to initiate seizure activity in right prefrontal cortex. Two open-label non-comparative studies suggested that FEAST has reduced cognitive side effects when compared to historical data from other forms of ECT. In two different ECT clinics, we compared the efficacy and cognitive side effects of FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT., Methods: Using a non-randomized, open-label design, 39 depressed adults were recruited after referral for ECT. Twenty patients received FEAST (14 women; age 45.2 ± 12.7), and 19 received RUL-UBP ECT (16 women; age 43.2 ± 16.4). Key cognitive outcome measures were the postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF). Antidepressant effects were assessed using the Hamilton Rating Scale for Depression (HRSD
24 )., Results: In the Intent-to-treat sample, a repeated measures mixed model suggested no between group difference in HRSD24 score over time (F1,35 = 0.82, p = 0.37), while the response rate favored FEAST (FEAST: 65%; RUL-UBP ECT: 57.9%), and the remission rate favored RUL-UBP ECT (FEAST: 35%; RUL-UBP ECT: 47.4%). The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6 ± 5.0 min; RUL-UBP ECT: 8.8 ± 5.8 min; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2 ± 14.2%; RUL-UBP ECT: 63.9 ± 9.9%; Cohens d = 0.43); findings that failed to meet statistical significance., Conclusions: FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects. A blinded, randomized, non-inferiority trial is needed., Competing Interests: Declaration of competing interest This study was supported in part by an unrestricted educational grant from the MECTA Corporation. The MECTA Corporation also provided custom-modified MECTA spECTrum 5000Q devices. Dr. Sackeim is the inventor on a patent for FEAST (US8712532 B2) and serves as a consultant to the MECTA Corporation, Neuronetics Inc, and LivaNova LPC. Dr. McCall receives research support from MECTA, Vistagen, and Merck. Dr. McCall receives royalties from Wolters Kluwer, and is a scientific adviser for Jazz, Sage, and Janssen Pharmaceuticals. None of the other authors have any conflicts. Dr. Youssef discloses that he receives research support (but not salary support) from the U.S. Department of Veterans Affairs, Augusta Biomedical Research Corporation, Merck & Co., VistaGen Therapeutics, Inc., and MECTA Corporation., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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