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 Adel Youssef, Dheeraj Ravilla, Cherishma Patel, Mark Yassa, Ramses F Sadek, Li Fang Zhang, Laryssa McCloud, William Vaughn McCall, Peter B. Rosenquist

Research output: Contribution to journalArticle

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).

Original languageEnglish (US)
Article number99
JournalBrain Sciences
Volume9
Issue number5
DOIs
StatePublished - May 1 2019

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Electroconvulsive Therapy
Seizures
Randomized Controlled Trials
Suicidal Ideation
Therapeutics
Suicide
Bipolar Disorder
Sample Size
Guidelines
Depression

Keywords

  • Electroconvulsive therapy
  • Focal ECT
  • Low amplitude seizure therapy
  • Mood disorders
  • Precision low amplitude seizure therapy
  • Randomized Clinical Trial
  • Seizure therapy
  • Treatment-resistant depression

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

@article{868e941da5404d52958a876bf3fe8e4f,
title = "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",
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-{\AA}sberg 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 = "Electroconvulsive therapy, Focal ECT, Low amplitude seizure therapy, Mood disorders, Precision low amplitude seizure therapy, Randomized Clinical Trial, Seizure therapy, Treatment-resistant depression",
author = "Youssef, {Nagy Adel} and Dheeraj Ravilla and Cherishma Patel and Mark Yassa and Sadek, {Ramses F} and Zhang, {Li Fang} and Laryssa McCloud and McCall, {William Vaughn} and Rosenquist, {Peter B.}",
year = "2019",
month = "5",
day = "1",
doi = "10.3390/brainsci9050099",
language = "English (US)",
volume = "9",
journal = "Brain Sciences",
issn = "2076-3425",
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TY - JOUR

T1 - Magnitude of reduction and speed of remission of suicidality for low amplitude seizure therapy (Lap-st) compared to standard right unilateral electroconvulsive therapy

T2 - A pilot double-blinded randomized clinical trial

AU - Youssef, Nagy Adel

AU - Ravilla, Dheeraj

AU - Patel, Cherishma

AU - Yassa, Mark

AU - Sadek, Ramses F

AU - Zhang, Li Fang

AU - McCloud, Laryssa

AU - McCall, William Vaughn

AU - Rosenquist, Peter B.

PY - 2019/5/1

Y1 - 2019/5/1

N2 - 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).

AB - 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).

KW - Electroconvulsive therapy

KW - Focal ECT

KW - Low amplitude seizure therapy

KW - Mood disorders

KW - Precision low amplitude seizure therapy

KW - Randomized Clinical Trial

KW - Seizure therapy

KW - Treatment-resistant depression

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DO - 10.3390/brainsci9050099

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