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临床试验/NCT02032576
NCT02032576已完成4 期

Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients

Kaohsiung Kai-Suan Psychiatric Hospital2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
170
试验地点
2
主要终点
Predictors of ECT response

研究概览

简要总结

Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive therapy (ECT) response. Although ECT is highly effective for treatment of patients with major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT, to predict ECT response early, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.

Methods: Patients with major depressive episode who require ECT treatment will be enrolled. ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17) and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Other measures also will be performed before the first ECT, at an expected average of 50 days, and at the end of follow-up period. Predictors of the response and relapse/recurrence after ECT and early prediction of ECT response will be obtained by statistic methods.

详细描述

Objective

Electroconvulsive therapy (ECT) is a safe and the most effective treatment for patients with major depressive episode, but the mechanism underlying the therapeutic action of this treatment is still unknown. Psychiatrists have long sought a quantifiable biomarker of ECT treatment response. Till now, no biomarker of ECT is used in clinical practice, but potential biomarkers that have been studied include brain-derived neurotrophic factor (BDNF), DNA polymorphism, RNA, electroencephalogram (EEG), auditory evoked potential (AEP), and cognitive function test. Although ECT is highly effective for treatment of major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT for patients with major depressive episode, to predict the ECT response, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.

Methods: Subjects with major depressive episode diagnosed according to DSM-IV criteria who require ECT treatment will be enrolled for study. ECT will be performed regularly using a brief-pulse, constant-current device. ECT will be given two or three times a week. The 17-item Hamilton Rating Scale for Depression (HAMD-17), Clinical Global Impression-severity (CGI-S), global assessment scale (GAF), UKU side effect rating scale and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Other measures collected before ECT and at an expected average of 50 days include Zung's Depression Scale (SDS), Short-Form 36 (SF-36), Work and Social Adjustment Scale (WSAS), plasma BDNF level, auditory evoked potentials (AEP), electroencephalography (EEG), neuropsychological test, and RNA. After ECT, CGI-S, HAMD-17, GAF and WSAS are reexamined monthly for 6 months. The definition of relapse/recurrence will be readmission, a HAM-D-17 score at least 18, or a CGI-S score at least 4 during the follow-up period. A logistic regression model will be used to obtain the predictors for ECT response. To establish the early prediction of ECT response, receiver operating characteristic curve (ROC) will be used to determine the cutoff point. Possible predictors related to relapse/recurrence will be analyzed using the Cox proportional hazards regression model.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of major depressive disorder or bipolar depression
  • Poor drug response
  • Severity or urgency of illness

排除标准

  • Subjects cannot write the imform consents
  • Subjects with severe physical illness

结局指标

主要结局

Predictors of ECT response

时间窗: an expected average of 50 days after initiation of ECT

Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Potential factors related to ECT response will be assayed. Early prediction model of response will be established.

Predictors of relapse/recurrence after ECT

时间窗: After ECT, HAMD-17 will be assessed monthly until the relapse/recurrence of the major depressive episode during the 6-month follow-up period.

The definition of relapse/recurrence of the major depressive episode will be readmission or a HAMD-17 score at least 18. Predictors (demographic and clinical variables) associated with time to relapse/recurrence during the 6-month follow-up period will be assayed using survival analysis.

次要结局

  • The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT(Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.)
  • The changes of cognitive functions after ECT(Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.)
  • Assessments of safety for general adverse events after ECT(UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.)
  • The changes of quality of life after ECT(Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.)
  • The changes of psychosocial functioning after ECT(Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.)
  • The changes of auditory evoked potentials (AEP) after ECT(Prior to undergoing the first ECT and at an expected average of 50 days, AEP will be tested.)
  • The changes of electroencephalography (EEG) after ECT(Prior to undergoing the first ECT and at an expected average of 50 days, EEG will be tested.)
  • The changes of RNA after ECT(Prior to undergoing the first ECT and at an expected average of 50 days, RNA will be extracted from the blood.)

研究者

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

Ching-Hua Lin, MD, PhD

Chief of Adult Psychiatry Department

Kaohsiung Kai-Suan Psychiatric Hospital

研究点 (2)

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