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与标准右侧单侧电休克治疗相比,低振幅癫痫发作疗法(LAP-ST)降低自杀倾向的幅度和缓解速度:一项双盲随机临床试验。

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.

作者信息

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

机构信息

Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA.

Office of Academic Affairs, Medical College of Georgia at Augusta University, Augusta, GA 30912, USA.

出版信息

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

DOI:10.3390/brainsci9050099
PMID:31035665
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6562950/
Abstract

: 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. : 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. : 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. : 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).

摘要

尽管治疗指南支持使用电休克疗法(ECT)治疗急性自杀倾向,但它会带来认知方面的副作用。低振幅癫痫发作疗法(LAP-ST)对自杀倾向的影响尚不清楚。我们之前在当前领域进行滴定的精准LAP-ST(pLAP-ST)已提供了人体概念验证数据,证明其在减少认知副作用方面具有优势。本报告的目的是:1)在随机分配的情况下,比较LAP-ST(500毫安)与标准右侧单侧(RUL)ECT(900毫安)在自杀倾向缓解程度方面的差异;2)比较LAP-ST与RUL ECT在自杀倾向缓解速度方面的差异。患者被随机分为LAP-ST组或RUL ECT组。使用描述性分析对蒙哥马利-Åsberg抑郁评定量表(MADRS)上与自杀观念(SI)项目相关的得分进行分析,由于本试点研究的先验样本量限制,未进行验证性统计分析。SI项目缓解定义为该项目得分在2分及以下。11名主要为单相或双相情感障碍的重度抑郁发作(MDE)患者签署了知情同意书。其中,7名符合条件并被随机分组纳入分析;除RUL ECT组中1名患者的自杀项目评分为2分之外,所有患者在基线时均有明显自杀倾向(自杀项目评分高于2分)。自杀倾向平均在第3次治疗时缓解,所有患者在第4次治疗时均实现缓解。从基线到终点,LAP-ST组SI平均得分改善了5.1分,RUL ECT组为3.0分。与标准RUL ECT相比,LAP-ST在自杀倾向缓解方面具有更大的效应量和更快的缓解速度。有必要进行进一步研究以重复这些发现。(ClinicalTrials.gov标识符:NCT02583490)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/6b91d44e262d/brainsci-09-00099-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/b57bfe88a4bf/brainsci-09-00099-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/03238379b88c/brainsci-09-00099-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/cae9e58c1470/brainsci-09-00099-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/6b91d44e262d/brainsci-09-00099-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/b57bfe88a4bf/brainsci-09-00099-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/03238379b88c/brainsci-09-00099-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/cae9e58c1470/brainsci-09-00099-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a63b/6562950/6b91d44e262d/brainsci-09-00099-g004.jpg

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