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临床试验/NCT04220099
NCT04220099已完成不适用

Pretreatment Electroencephalogram (EEG) May Predict Electroconvulsive Therapy(ECT) Effect in Schizophrenia

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
EEG functional connectivity difference between response and nonresponse group

研究概览

简要总结

This study is designed to find quantitative Electroencephalogram(qEEG) biomarkers to predict Electroconvulsive Therapy(ECT) Response in Schizophrenia

详细描述

The purpose of this proposal is to explore quantitative Electroencephalogram(qEEG) biomarkers that would predict Electroconvulsive Therapy(ECT) Response in Schizophrenia (SZD). The investigators will recruit 30 SZD patients who are preparing for ECT treatment and assesse psychotic symptoms using Positive and Negative symptom scale(PANSS) before and after 8-sessions clinical course of ECT treatment. These patients needed ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines. Meanwhile resting EEG will be recorded for 10 minutes before the first episode of ECT treatment. Decrease of PANSS scores will be calculated after the last session of ECT treatment to distinguish responder/non-responder.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-5 criteria for SZD
  • patients needed ECT treatment assessed by clinicians using American psychological Association(APA) guidelines.
  • symptoms must be of at least moderate severity (PANSS score >71)
  • age between 18 to 60 years old
  • medications will be stable for at least four weeks prior to ECT, and there will be no dose changes unless medically necessary

排除标准

  • any additional current psychiatric comorbidity
  • pregnancy or prepare to have a baby
  • current use of any Antiepileptic drugs
  • history of taking any kinds of Physicotherapeutics within 6 months
  • severe psychotic symptoms that make patients could not accomplish the clinical interview

结局指标

主要结局

EEG functional connectivity difference between response and nonresponse group

时间窗: through study completion, an average of 6 months

This is a predictive indicator collected before ECT treatment. After treatment, we divided 30 patients into response and nonresponse group using PANSS. Then we explore differences in pretreatment EEG functional connectivity at different frequency bands (Alpha, Beta, Delta, and Theta) to find a predictable biomarker for ECT treatment effect.

Change in Positive and negative syndrome scale(PANSS)score

时间窗: up to 4 weeks

It assessed the severity of psychotic symptoms.The responder on PANSS is defined as a PANSS decrease at least 25% from the baseline at post-treatment. PANSS helps us divide cases into response and nonresponse group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Wang

vice-president

Shanghai Mental Health Center

研究点 (1)

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