Effects of Neurexan ® in an experimental acute stress setting — An explorative double-blind study in healthy volunteers

Abstract

AimsThe objective of this study was to assess the efficacy profile of Nx4 (Neurexan ®) in an acute experimental stress setting. An acute stress reaction is a biopsychological condition arising in response to an event that is individually regarded as emotionally stressful. Medications can mitigate stress perception and stress reactions, but may also have side effects. Materials and methodsSixty-four healthy male and female volunteers participated in this prospective two-arm two-site study following an explorative randomized placebo-controlled double-blind study design. Participants took six tablets of either Nx4 or placebo during a time period of 2.5h before exposure to an acute psychological stressor (Trier Social Stress Test), and were subsequently monitored for 1.5h. Subjective stress ratings as well as cardiovascular and neuroendocrine parameters were analyzed before and after stress exposure. Key findingsAll changes in primary and secondary efficacy parameters corresponded well with the experimental acute stress setting. Nx4 did not affect subjective stress ratings but significantly diminished stress-induced increases in salivary cortisol and plasma adrenaline. Nx4 was as safe as placebo and very well tolerated. SignificanceThe results suggest an attenuated neuroendocrine stress response in healthy volunteers induced by Nx4. However, further investigations are needed to confirm these observations as well as to better understand why some parameters were affected while others were not. Future investigations should be extended to chronically stressed individuals with a greater disposition to experience stress in everyday life.ClinicalTrials.gov Identifier: NCT01703819