Magnitude of Reduction and Speed of Remission of Suicidality for Low Amplitude Seizure Therapy (LAP-ST) Compared to Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial

Nagy A Youssef; Dheeraj Ravilla; Cherishma Patel; Mark Yassa; Ramses Sadek; Li Fang Zhang; Laryssa McCloud; William V McCall; Peter B Rosenquist

doi:10.3390/brainsci9050099

Magnitude of Reduction and Speed of Remission of Suicidality for Low Amplitude Seizure Therapy (LAP-ST) Compared to Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial

Brain Sci. 2019 Apr 29;9(5):99. doi: 10.3390/brainsci9050099.

Authors

Nagy A Youssef^{1

2}, Dheeraj Ravilla³, Cherishma Patel⁴, Mark Yassa⁵, Ramses Sadek^{6

7}, Li Fang Zhang⁸, Laryssa McCloud⁹, William V McCall¹⁰, Peter B Rosenquist¹¹

Affiliations

¹ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. nyoussef@augusta.edu.
² Office of Academic Affairs, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. nyoussef@augusta.edu.
³ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. LRAVILLA@augusta.edu.
⁴ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. CHEPATEL@augusta.edu.
⁵ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. MYASSA@augusta.edu.
⁶ Department of Population Health Science, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. RSADEK@augusta.edu.
⁷ Georgia Cancer Center, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. RSADEK@augusta.edu.
⁸ Department of Population Health Science, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. LIZHANG@augusta.edu.
⁹ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. LMCCLOUD@augusta.edu.
¹⁰ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. WMCCALL@augusta.edu.
¹¹ Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA. PROSENQUIST@augusta.edu.

Abstract

Background: Although treatment guidelines support use of electroconvulsive therapy (ECT) for acute suicidality, it is associated with cognitive side effects. The effect of Low Amplitude Seizure Therapy (LAP-ST) on suicidality is unknown. Our prior precision LAP-ST (pLAP-ST) performing titrating in the current domain has provided initial proof of concept data in humans of its advantage in terms of reduction of cognitive side effects. The aims of this report are to: 1) compare LAP-ST (at 500mA) versus standard Right Unilateral (RUL) ECT (at 900 mA) in terms of magnitude of remission of suicidality in a randomized allocation and 2) compare the speed of remission of suicidality between LAP-ST versus RUL ECT. Methods: Patients were randomized to either LAP-ST or RUL ECT. The scores pertaining to the suicidal ideation (SI) item on the Montgomery-Åsberg Depression Rating Scale (MADRS) were analyzed using descriptive analysis and no confirmatory statistical analysis was performed due to a priori sample size limitations for this pilot study. SI item remission was defined as 2 or below on this item. Results: Eleven patients with major depressive episode (MDE) of mainly unipolar or bipolar disorders signed consent. Of these, 7 were eligible and were randomized and included in the analysis; all were actively suicidal at baseline (suicide item above 2), except 1 patient who had suicide item at 2 in the RUL ECT group. Suicidality remitted on average by session 3 and remission occurred for all patients by session 4. The SI mean score improvement from baseline to endpoint for LAP-ST was 5.1 and for RUL ECT was 3.0. Conclusions: LAP-ST has larger effect size and speed of remission of suicidality compared to standard RUL ECT. Future studies are warranted for replicating these findings. (ClinicalTrials.gov ID: NCT02583490).

Keywords: Randomized Clinical Trial; electroconvulsive therapy; focal ECT; low amplitude seizure therapy; mood disorders; precision low amplitude seizure therapy; seizure therapy; treatment-resistant depression.

Associated data

ClinicalTrials.gov/NCT02583490

Grants and funding

(NY)/Augusta University and Office of Academic Affairs