Status:
COMPLETED
Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress
Lead Sponsor:
Max Zeller Soehne AG
Conditions:
The Primary Condition Studied for This Trial is Acute Stress
Eligibility:
MALE
18-45 years
Phase:
PHASE4
Brief Summary
The objective of the STRESS trial is to investigate in a mode of action setting the effect of Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute stress in he...
Eligibility Criteria
Inclusion
- Age:18 - 45 years
- Written informed consent
- Male gender
Exclusion
- Any acute or chronic somatic or psychiatric disorder
- Smoking
- Any clinically relevant hepatic disorder
- Any clinically relevant renal disorder
- Any clinically relevant cardiac disorder
- Any clinically relevant respiratory disease (e.g. Asthma)
- Diabetes mellitus
- Any abnormal lab values suggesting diseases from exclusion criteria
- Known allergies to trial medication and excipients
- Alcohol or other drug abuse (e.g. cannabis)
- Concomitant participation in another clinical trial or \<4 weeks ago
- Participation in any psychotherapy
- Already participated in a TSST
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02189239
Start Date
January 1 2015
End Date
June 1 2015
Last Update
June 25 2015
Active Locations (1)
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1
Phase I Research Unit, University Hospital Basel
Basel, Switzerland, 4031