Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an experimental stress test called the Trier Social Stress Test

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biologische Heilmittel Heel GmbH

Criteria

Inclusion 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

Exclusion Criteria:

1. allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate) or Placebo

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