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临床试验/NCT03915821
NCT03915821已完成不适用

Memory Changes in Patients With Major Depression Disorder Treated With Electroconvulsive Therapy

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Evaluate the subjective memory changes present in a sample of patients with major depression disorder who admitted to psychiatry unit and evaluation of memory changes following ECT treatment

研究概览

简要总结

The basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ECT.

详细描述

Current literature provides insufficient information on the degree of cognitive impairment during and after electroconvulsive therapy (ECT), mostly due to the fact that applied tests lacked sensitivity and flexibility. Our goal was to evaluate cognitive functioning in adult depressed patients treated with bi & uni lateral & ECT, using tests sensitive for detection of possible acute and medium-term memory changes.(9) Major depressive disorder (MDD) is estimated to affect around 16 million Americans (Substance Abuse and Mental Health Services Administration [SAMHSA], 2013) and, according to the World Health Organization, is the leading cause of disability worldwide (World Health Organization 2012). Among In the U.S. workforce, the prevalence of MDD has been estimated at 7.6% .(2) Electroconvulsive therapy (ECT) is an effective treatment for severe depression but entails cognitive adverse effects, particularly the effects on memory. ECT may cause a temporary deficit in the cognitive processes of information encoding, consolidation, and retrieval. Transient memory disturbances are regarded as an inevitable adverse effect of therapeutic convulsions. Various strategies have been tried to decrease the cognitive adverse effects while retaining the antidepressant effect, including the use of unilateral instead of bilateral electrode placement, changes in waveform, and reducing the electrical stimulus intensity, (4).

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed as having major depression according to DSM V.
  • •Patients aged (18-50 years) of both sexes.

排除标准

  • •History or current evidence of systemic medical illness, e.g.: hepatic, renal, cardiovascular, endocrinal, metabolic disorders or others.
  • •History or current evidence of any Neurological disease.
  • •Pregnant females.
  • •Co-morbid psychiatric disorders other than depression.
  • •Patients with mental subnormality.

研究组 & 干预措施

Patients diagnosed as major depression according to DSM V

Experimental

All patients presented with major depression disorder not received ECT previously within 6 monthes, admitted to the study site ( Psychiatry department, in Assiut University Hospital, Assiut, Egypt). They Fulifilled will be recruited within 6 monthes duration .

The patients classified into group A comprised that will be treated with Unipolar ECT, and group B comprised that will be treated Biploar ECT.

干预措施: ECT (Device)

结局指标

主要结局

Evaluate the subjective memory changes present in a sample of patients with major depression disorder who admitted to psychiatry unit and evaluation of memory changes following ECT treatment

时间窗: Baseline

* Hamiliton rate Scale for depression,(HAM-D) (Appendix II),before and after treatment with ECT. * All Scales will be taken at date of admission,and at discharge up to 15 days and after three months of discharge .

Evaluate the subjective memory changes present in a sample of patients with major depression disorder who admitted to psychiatry unit and evaluation of memory changes following ECT treatment .

时间窗: Baseline

Reach the least level of side effects in memory of Recent treatment with ECT in patient with major depression. measurement tool: _ History taking and full general \& neurological examination to exclude any neurological disease. * Minim Mental State Examination, (MMSE) (Appendix I) * All Scales will be taken at date of admission, and at discharge up to 15 days and after three months of discharge . * All patients will be subjected to full psychiatric history and examination. The results of the above mentioned laboratory, investigations will be included in future analysis and interpretation of patients' abnormal psychiatric findings.

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

Ayman Nabiel Abd-Elhakeem Metawlly

Resident Doctor

Assiut University

研究点 (1)

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