Study to investiagte the effect of Neurexan vs natural course in healthy volunteers under an experimental acute stress setting

• Conditions: eurexan to be effective in fostering mental balance by reducing tension and nervousness during acute stress setting in healthy probands; MedDRA version: 15.1Level: LLTClassification code 10042219Term: Stress testSystem Organ Class: 100000004848; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2012-002359-40-DE
• Lead Sponsor: Biologische Heilmittel Heel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-15
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified