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临床试验/ISRCTN77277298
ISRCTN77277298已完成不适用

Phase III study on the efficacy and safety of Hypericum extract WS® 5570 in patients with a Major Depressive Episode

Schwabe Pharmaceuticals (Germany)0 个研究点目标入组 320 人开始时间: 2005年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
320

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

性别
All

入选标准

  • 1. Diagnosis of a major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (single episode: 296.21, 296.22, recurrent episode: 296.31, 296.32)
  • 2. Severity of depression on the baseline visit: Hamilton rating scale for depression (17-HAMD) total score =18 and HAMD item 'depressive mood' =2

排除标准

  • 1. Any of the following psychiatric diagnosis according to DSM-IV: schizophrenia (295.x, 297.x, 298.x), acute anxiety disorder (300.x, 302.x) as primary diagnosis, adjustment disorder (309.x), episodes of depression with any characteristics of a psychotic nature (296.24, 296.34), depressive disorders not defined as inclusion criteria (e.g. 300.4, 311), bipolar disorder (296.0, 296.4, 296.5, 296.6, 296.7, 296.8, 301.13), organic mental disorder (International Statistical Classification of Diseases and Related Health Problems - tenth revision [ICD-10]: F06), acute post traumatic stress disorder (309.81), abuse of any substance; risk of suicide
  • 2. Lack of response to any adequate antidepressant therapy in the present episode
  • 3. Duration of the index episode greater than 1 year
  • 4. Concomitant medication with any psychotropic drug
  • 5. Any clinical relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases

研究者

发起方
Schwabe Pharmaceuticals (Germany)

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