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).
Highlights
Among the leading causes of death, suicide is one of only three causes that are increasing [1,2].In 2016, about 45,000 people ≥10 years of age died of suicide (15.6/100,000) in the United States [1].Suicide rates increased from 1999 to 2015 [3,4], with adults aged 45–64 having the highest rate of increase (from 13.2 per 100,000 persons (1999) to 19.2 per 100,000 (2016)) [1,4]
One patient was discontinued by the treating psychiatrist prior to the treatment session due to deeming clinical condition to necessitate standard of care electroconvulsive therapy (ECT) in a non-randomized fashion
Seven patients were included in the intention to treat analysis
Summary
Among the leading causes of death, suicide is one of only three causes that are increasing [1,2].In 2016, about 45,000 people ≥10 years of age died of suicide (15.6/100,000) in the United States [1].Suicide rates increased from 1999 to 2015 [3,4], with adults aged 45–64 having the highest rate of increase (from 13.2 per 100,000 persons (1999) to 19.2 per 100,000 (2016)) [1,4]. Major depressive episode (MDE)—whether being part of major depressive disorder (MDD), bipolar disorder (BD) or schizoaffective disorder—is a major risk for suicide [5,6]. Of those with MDE, up to a third present with treatment-resistant depression (TRD) [7,8]. Treatment guidelines support use of electroconvulsive therapy (ECT) for acute suicidality, it is associated with cognitive side effects. Seizure Therapy (LAP-ST) on suicidality is unknown. Methods: Patients were randomized to either LAP-ST or RUL ECT. The scores pertaining to the suicidal ideation (SI) item on the Montgomery-Åsberg
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