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临床试验/JPRN-jRCT2080225180
JPRN-jRCT2080225180已完成2 期

A phase 2 study of S-812217 in patients with major depressive disorder

SHIONOGI & CO., LTD.0 个研究点目标入组 240 人开始时间: 2020年4月28日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
240

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 <= 75age old(—)
性别
All

入选标准

  • Patients who have been interviewed using Mini-International Neuropsychiatric. Interview (M.I.N.I) and diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) and met the following 2 conditions:
  • - The current episode is ongoing for at least 8 weeks prior to the day of signing the informed consent form
  • - Duration of current episode is <= 12 months prior to signing the informed consent

排除标准

  • - Patients with treatment-resistant depression (defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants [excluding antipsychotics] within the current depressive episode from two or more different classes for at least 4 weeks of treatment). (The Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH ATRQ] will be used for the evaluation)
  • - Patients who have been treated with devices such as vagal nerve stimulation, electroconvulsive therapy, and transcranial magnetic stimulation within the current depressive episode.

研究者

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