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)
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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