EUCTR2012-002359-40-DE进行中（未招募）不适用
EUPRO OL, Efficacy profile of Neurexan® in an experimental acute stress setting – an explorative open-label study in healthy probands
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
- •For inclusion in the study, volunteers must fulfil all of the following criteria:
- •1. Provide written informed consent
- •2. Healthy male or female
- •3. age between 31 to 59 years
- •4. fluent in German language
- •5. Ability to understand the explanations and instructions given by the study physician
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1. allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate)
- •2. lactose intolerance
- •3. use of any psychological stress-management intervention within the last 4 weeks
- •4. sick leave for any reason
- •5. participation in any other clinical study 3 months prior to Screening Visit
- •6. current or recent (3 months prior to Screening Visit) history of substance abuse or drug dependence including nicotine and alcohol (as verified in the respective IDCL list)
- •7. smokers
- •8. alcohol intake within last 24 hours (before Baseline Visit V3)
- •9. shift workers or work regularly during night time
- •10. use of any psychotropic medication or suffering from severe psychiatric illness needing acute intervention
- •11. BMI > 30 kg/m2
- •12. currently pregnant (verified by urine pregnancy test) or lactating
- •13. participation in a previous TSST study
- •14. high chronic stress as verified with the TICS-SSCS (a score of = 23 on the screening scale for chronic stress meets the criterion of being chronically stressed)
- •15. major mental disorder as verified with the IDCL (depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.)
- •16. employee of the Sponsor, one of the investigators or the CRO
- •17. use of any concomitant medication except contraceptives
- •18. any somatic disease or other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results
- •19. Individuals whose ability to speak for themselves lacks or can be doubted
研究者
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