Efficacy and safety of Neurodoron in patients with nervous exhaustion - a randomized, double-blind, placebo-controlled clinical trial - Neurodoron vs. Placebo

Weleda AG0 个研究点开始时间: 2011年4月5日最近更新: 2012年12月3日

适应症

试验速览

暂无简介。

•1. Informed consent
•2. At least 18 years of age
•3. Confirmed diagnosis of nervous exhaustion according to the definition for neurasthenia as laid down in the WHO-criteria for research
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•1. Known hypersensitivity against wheat starch
•2. Organic disease responsible for exhaustion
•3. Neuro-psychiatric disease causing exhaustion
•4. Presumed major depression, defined by BDI-II (Beck Depression Inventary) =29
•5. Presumed major panic disorder or generalised anxiety disorder defined by GAD-7-score =16
•6. Concomitant therapy interfering with IMP
•7. Commitment to an institution because of official or judicial order
•8. Pregnancy, lactation

发起方