Double-Blinded Randomized Pilot Clinical Trial Comparing Cognitive Side Effects of Standard Ultra-Brief Right Unilateral ECT to 0.5 A Low Amplitude Seizure Therapy (LAP-ST)

Nagy A Youssef; William V McCall; Dheeraj Ravilla; Laryssa McCloud; Peter B Rosenquist

doi:10.3390/brainsci10120979

Double-Blinded Randomized Pilot Clinical Trial Comparing Cognitive Side Effects of Standard Ultra-Brief Right Unilateral ECT to 0.5 A Low Amplitude Seizure Therapy (LAP-ST)

Brain Sci. 2020 Dec 13;10(12):979. doi: 10.3390/brainsci10120979.

Authors

Nagy A Youssef^{1

2}, William V McCall¹, Dheeraj Ravilla¹, Laryssa McCloud¹, Peter B Rosenquist¹

Affiliations

¹ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA.
² Eisenhower Army Medical Center, Department of Behavioral Health, Fort Gordon, GA 30905 USA.

Abstract

Background: Concerns over cognitive side effects (CSE) of electroconvulsive therapy (ECT) still limit its broader usage for treatment-resistant depression (TRD). The objectives of this study were to (1) examine the CSE of Low Amplitude Seizure Therapy (LAP-ST) at 0.5 A compared to Ultra-brief Right Unilateral (UB-RUL) ECT using Time to Reorientation (TRO) as the main acute primary outcome, and (2) to compare effects on depressive symptoms between the two treatment groups.

Methods: Participants were referred for ECT, consented for the study, and were randomized to a course of LAP-ST or standard UB-RUL ECT. TRO and depression were measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).

Results: Eleven patients consented. Of these, eight with a current major depressive episode (MDE) of unipolar or bipolar disorders were randomized. TRO was faster for the LAP-ST (mean = 6.8 min; SE = 4.9) than standard RUL ECT (mean = 15.5 min; SE = 6.5). Depression improved similarly in the two arms of the study from baseline (MADRS: LAP-ST = 41.0; SE = 2.0, RUL = 39.0; SE = 3.8) to endpoint (MADRS score: LAP-ST = 8.0; SE7.2, RUL = 9.5; SE = 3.8).

Conclusions: This pilot, randomized and blinded clinical trial, suggests that the LAP-ST (at 0.5 A) has faster reorientation and possibly lower CSE compared to standard RUL-UB ECT. Caution is advised in interpreting these results due to the small sample size of this pilot study. Thus, future studies with similar design are warranted for replicating these findings.

Keywords: ECT; cognitive side effects; current titration; electroconvulsive therapy; low amplitude seizure therapy; mood disorders; neurostimulation; precision ECT; seizure therapy; treatment-resistant depression.