Explorative Open Label Study of Efficacy Profile of Neurexan® in Experimental Acute Stress Setting in Healthy Subjects (NEUPRO-OL)

Biologische Heilmittel Heel

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Stress Reaction

Treatments

Drug: Neurexan®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01703832

2012-002359-40 (EudraCT Number)

C1202

Details and patient eligibility

About

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

Full description

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®.

Enrollment

65 patients

Sex

All

Ages

31 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provide written informed consent
Healthy male or female
age between 31 to 59 years
Fluent in German language.
Ability to understand the explanations and instructions given by the study physician

Exclusion criteria

allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate)
lactose intolerance
use of any psychological stress-management intervention within the last 4 weeks
sick leave for any reason
participation in any other clinical study 3 months prior to Screening Visit
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)
smokers
alcohol intake within last 24 hours (before Baseline Visit V3)
shift workers or work regularly during night time
use of any psychotropic medication or suffering from severe psychiatric illness needing acute intervention
BMI > 30 kg/m2
currently pregnant (verified by urine pregnancy test) or lactating
participation in a previous TSST study
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)
major mental disorder as verified with the IDCL (depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.)
employee of the Sponsor, one of the investigators or the CRO
use of any concomitant medication except contraceptives
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
Individuals whose ability to speak for themselves lacks or can be doubted