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Completed

NCT Number: NCT02189239

Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

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).

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Key information

Conditions

The Primary Condition Studied for This Trial is Acute Stress

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Phase I Research Unit, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zeller Entspannung film coated tablet

Drug

Placebo

Drug

No treatment

Other

Primary outcomes

  1. 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.

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Max Zeller Soehne AG

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2014
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.