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临床试验/EUCTR2008-001417-26-DE
EUCTR2008-001417-26-DE进行中(未招募)不适用

Double blind, randomized, placebo-controlled, mulitcentric clinical trial to evaluate the relapse prevention of a hypericum extract in outdoor patients with moderate depressive episodes (major depression)

Steigerwald Arzneimittelwerk GmbH0 个研究点开始时间: 2008年9月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Phase 1: age 18-70 years, diagnosis according to DSM-IV-TR: 296.32; total score of HAMD-17 20-24 points. At least 5 of the listed symptoms are to exist for 2 weeks (at least 1 of them = main symptom, like depressive mood or loss of interest and joy).
  • Phase 2: Responder of phase 1 (= decrease of HAMD-17 total score of at least 50% after a 12-week treatment with Laif 900).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Phase 1 and 2: incapable of contructing and attanded patients according to the Betreuungsgesetz (BtG); simple mourning reaction; drugs that may influence the efficacy of or could be influenced by the investigational product; pregnancy and nursing; cancer or AIDS (HIV positive)

研究者

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