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临床试验/JPRN-jRCTs042220158
JPRN-jRCTs042220158招募中2 期

Repetitive transcranial magnetic stimulation maintenance treatment for outpatients with major depressive disorder who are clinically stable by electroconvulsive therapy following treatment failure with antidepressant in the current episode: a double-blind, randomized, sham-controlled trial

Sakuma Kenji0 个研究点目标入组 58 人开始时间: 2023年3月13日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
58

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • 1. The clinical trial will be described in detail to the individuals, and would be written informed consent will be obtained from all participants and their guardians
  • 2. Individuals over 18 years old
  • 3. Individuals will meet the DSM-5 criteria for major depressive disorder
  • 4. Individuals who will be clinically stable by electroconvulsive therapy following treatment failure with antidepressant in the current episode (HAM-D17 total score of less than 8)
  • DSM-5: Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition
  • HAM-D17: 17-item Hamilton Rating Scale for Depression

排除标准

  • 1. Individuals with metal implants or devices close to the stimulation site (e.g., cochlear implants, surgical clips with magnetic properties, or neurostimulators such as deep brain stimulation or vagus nerve stimulation), individuals with cardiac pacemaker
  • 2. Individuals with metal implants or devices not close to the stimulation site (e.g., implanted medication pumps), titanium products in their heads, magnetic dentures/implants
  • 3. Individuals with a history of seizures, a history of intracranial lesions at risk for seizures, individuals taking drugs that reduce seizure threshold (e.g., tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, or zotepine), individuals with alcohol/caffeine/stimulants abuse or withdrawal symptoms, pregnant individuals, individuals with severe physical disease
  • 4. Individuals with a history of receiving repetitive transcranial magnetic stimulation in the current depressive episode
  • 5. Individuals with dementia, organic or symptomatic mood disorder
  • 6. Individuals with anxiety and depressive symptoms who do not meet the diagnostic criteria for depressive episode (moderate to severe depression) for the following mental disorders: neurotic, stress-related and somatoform disorders iincluding adjustment disorders, disorders of adult personality and behaviour, pervasive developmental disorders (autism spectrum disorder), or hyperkinetic disorders (attention-deficit/hyperactivity disorder)
  • 7. Individuals with low adherence to antidepressants
  • 8. Individuals with substance or medication-induced mood disorder
  • 9. Individuals with bipolar disorder
  • 10. First episode major depressive disorder
  • 11. Individuals judged that researchers are inappropriate to participate in the study

研究者

发起方
Sakuma Kenji

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