Trait anxiety is related to Nx4's efficacy on stress-induced changes in amygdala-centered resting state functional connectivity: a placebo-controlled cross-over trial in mildly to moderately stressed healthy volunteers.

Tytuł:: Trait anxiety is related to Nx4's efficacy on stress-induced changes in amygdala-centered resting state functional connectivity: a placebo-controlled cross-over trial in mildly to moderately stressed healthy volunteers.
Autorzy:: Nanni-Zepeda M; Department of Psychiatry and Psychotherapy, Jena University Hospital, Philosophenweg 3, 07743, Jena, Germany.
Alizadeh S; Department of Psychiatry and Psychotherapy, Jena University Hospital, Philosophenweg 3, 07743, Jena, Germany.
Chand T; Department of Psychiatry and Psychotherapy, Jena University Hospital, Philosophenweg 3, 07743, Jena, Germany.
Kasties V; Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.
Fan Y; Leibniz Research Centre for Working Environment and Human Factors, Ardeystraße 67, 44139, Dortmund, Germany.
van der Meer J; Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands.
Herrmann L; Department of Psychiatry and Psychotherapy, Jena University Hospital, Philosophenweg 3, 07743, Jena, Germany.
Vester JC; idv Data Analysis and Study Planning, Tassilostraße 6, 82131, Gauting, Germany.
Schulz M; Biologische Heilmittel Heel GmbH, Dr.-Reckeweg-Str. 2-4, 76532, Baden-Baden, Germany.
Naschold B; Biologische Heilmittel Heel GmbH, Dr.-Reckeweg-Str. 2-4, 76532, Baden-Baden, Germany.
Walter M; Department of Psychiatry and Psychotherapy, Jena University Hospital, Philosophenweg 3, 07743, Jena, Germany. .
Źródło:: BMC neuroscience [BMC Neurosci] 2022 Nov 24; Vol. 23 (1), pp. 68. Date of Electronic Publication: 2022 Nov 24.
Typ publikacji:: Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: London: BioMed Central, [2000-
MeSH Terms:: Amygdala*/diagnostic imaging
Anxiety*
Humans ; Cross-Over Studies ; Healthy Volunteers ; Neural Pathways/physiology
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Contributed Indexing:: Keywords: Amygdala Complementary therapies; Anxiety; FMRI; Neurexan; Stress
Molecular Sequence:: ClinicalTrials.gov NCT02602275
Entry Date(s):: Date Created: 20221126 Date Completed: 20221129 Latest Revision: 20230204
Update Code:: 20240105
PubMed Central ID:: PMC9694608
DOI:: 10.1186/s12868-022-00754-4
PMID:: 36434512
: Czasopismo naukowe

Pełny tekst

Background: The multicomponent drug Neurexan (Nx4) was shown to reduce the neural stress network activation. We now investigated its effects on stress-induced resting state functional connectivity (RSFC) in dependence of trait anxiety (TA), an acknowledged vulnerability factor for stress-induced psychopathologies.
Methods: Nx4 was tested in a randomized placebo-controlled crossover trial. Resting state fMRI scans were performed before and after a psychosocial stress task and exploratively analyzed for amygdala centered RSFC. Effects of Nx4 on stress-induced RSFC changes were evaluated and correlated to TA levels. A subgroup analysis based on TA scores was performed.
Results: Multiple linear regression analysis revealed a significant correlation between TA and Nx4 effect on stress-induced RSFC changes between right amygdala and pregenual anterior cingulate cortex (pgACC) and ventro-medial prefrontal cortex (vmPFC). For participants with above average TA, a significant amelioration of the stress-induced RSFC changes was observed.
Conclusions: The data add evidence to the hypothesis that Nx4's clinical efficacy is based on a dampened activation of the neural stress network, with a greater neural response in subjects with anxious personality traits. Further studies assessing clinically relevant outcome measures in parallel to fMRI are encouraged to evaluate the real-world benefit of Nx4. Trial registration NCT02602275.
(© 2022. The Author(s).)

Erratum in: BMC Neurosci. 2023 Feb 3;24(1):11. (PMID: 36737695)

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