Explorative Open Label Study of Efficacy Profile of Neurexan® in Experimental Acute Stress Setting in Healthy Subjects

Biologische Heilmittel Heel GmbH65 enrolled

Overview

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

An acute stress reaction is a biopsychological condition arising in response to an event which is individually regarded as emotionally stressful. The onset of a stress response is associated with specific physiological actions in the sympathetic nervous system, both directly and indirectly through the release of adrenaline and to a lesser extent noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate immediate physical reactions by triggering increases in heart rate and breathing, constricting blood vessels. The other major player in the acute stress response is the hypothalamic-pituitary-adrenal axis. Although stress has been described as a non-specific psychophysiological response to environmental stimuli, it is possible to discern specific bodily stress responses caused by specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli. For example, social stress induces elevated cortisol levels, particularly if the stressor is uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment of others such as in the Trier Social Stress Test). Usually, the TSST induces a two-fold increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also, an average increase in heart rates of around 20 beats per minute (bpm) is observed during the TSST. In addition, emotional states and feelings have been shown to be affected by this stress test, such as marked increases in stress perception,anxiety and emotional insecurity as well as decreases in mood, calmness and feeling awake. Preliminary results indicate that Neurexan® may improve coping abilities in stressful situations. This study aims to investigate the effect of Neurexan® on subjectively perceived nervousness and tension during an acute stressful situation and to characterize the efficacy profile of Neurexan®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Stress Reaction

Interventions

Neurexan®DRUG

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Eligibility

Sex: ALLMin age: 31 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) 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

Locations (2)

Institut fur Medizinische Psychologie und Verhaltensimmunbiologie Universitatsklinikum Essen

Essen, Germany

Klinische Psychologie und Psychotherapie, Fachbereich Psychologie, Universität Marburg

Marburg, Germany

Outcomes

Primary Outcomes

Acute Stress Measured by Tension

Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = "not at all" to 100 = "highly". The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method.

Time frame: -210 minutes to +100 minutes

Acute Stress Measured by Nervousness

Time frame: -210 minutes to +100 minutes

Secondary Outcomes

Changes in Saliva Alpha Amylase

The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.

Time frame: -60 minute, +15 minute , + 45 minute, +100 minute

Changes in Saliva Cortisol

Data from ClinicalTrials.gov

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