Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

Study Overview
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Brief Summary
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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 healthy male volunteers. In addition, data on safety and tolerability of Zeller Entspannung will be obtained. A third arm including no treatment is tested as well. Approximately 72 healthy volunteers will be included into this randomized, double blind study. Study duration will be 7 days, study medication intake will be over 4 days: participants will take the medication one tablet three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two tablets will be taken (morning and midday).

Official Title
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A Phase IV, Randomised, Placebo Controlled Study to Investigate the Effects of Zeller Entspannung Film Coated Tablets on Cortisol Responses in Healthy Volunteers With Acute Stress

Conditions
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The Primary Condition Studied for This Trial is Acute Stress

Intervention / Treatment
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* Drug: Zeller Entspannung film coated tablet
* Drug: Placebo
* Other: No Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18 - 45 years Written informed consent Male gender Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zeller Entspannung film coated tablets<br>Relaxing film coated tablets, 570 mg (Zeller Entspannung Filmtabletten), 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) preferably during meals with a glass of water. | Drug: Zeller Entspannung film coated tablet<br> <br> |
| Placebo Comparator: Placebo tablets<br>Placebo medication is identical in presentation, color and shape, 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) during meals with a glass of water. | Drug: Placebo<br> <br> |
| Sham Comparator: No Treatment<br>No medication intake. | Other: No Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to demonstrate in healthy male volunteers that Zeller Entspannung reduces overall saliva cortisol level (AUCg) after acute stress compared with a placebo. |  | 4 days |