Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study

Abstract

Etifoxine hydrochloride (Stresam^®), a treatment indicated for psychosomatic manifestations of anxiety, could be an alternative to benzodiazepines. While no impact on alertness and cognitive functions has been proven among youth, data on elderly are lacking. The primary objective of this study was to measure the impact of etifoxine, lorazepam or placebo on alertness in the elderly. The secondary objectives were to evaluate cognitive performances and adverse effects. In this randomized, placebo-controlled, double-blind, 3-way crossover design, 30 healthy volunteers aged 65 to 75 years underwent three one-day sessions. After treatment intake, standardized cognitive tests were conducted using the Cambridge Neuropsychological Test Automated Batteries and other psychological tests (Stroop, Rey Auditory Verbal Learning Test, Digit Span). The reaction time (RTI) as primary endpoint was analysed using a 3 × 3 latin square variance analysis. A 100-mg dose of etifoxine has no deleterious impact on alertness and causes no cognitive disorders as compared to placebo (RTI: 744 ± 146 ms versus 770 ± 153 ms; p = 1.00). As expected, a 2-mg dose of lorazepam impairs alertness (RTI: 957 ± 251 ms versus placebo; p < 0.0001) and cognitive functions. A similar frequency of adverse events was observed with etifoxine and placebo while their incidence was 3-fold higher with lorazepam, drowsiness being the most frequent adverse event. No serious adverse events were observed. This study demonstrates in the elderly that a single dose of etifoxine does neither impair alertness nor any of the cognitive parameters evaluated. Etifoxine may be a good option when anxiolytic treatment is required, especially in elderly people.

Trial registration: ClinicalTrials.gov NCT02147548.

Keywords: Anxiolytic; Benzodiazepines; Cognition; Elderly; Etifoxine; Geriatric psychiatry.