Acute Stress Reaction Clinical Trial
Official title:
Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting - an Explorative Open-Label Study in Healthy Probands
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®.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01703819 -
Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06390267 -
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
|
N/A | |
| Completed |
NCT02602275 -
Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands
|
Phase 2 |