Clinical trial NCT02147548: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
Official title: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly. A Monocentric, Randomized, Cross-over, Double-blind Clinical Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged from 65 to 75 years
* Right-handed subject (Edinburgh Handedness inventory)
* Subject having signed the consent form
* Subject having agreed to be listed on the French National Healthy Volunteers database
* Subject affiliated or beneficiary to French social insurance

Exclusion Criteria:

* Subject presenting a neurological or psychiatric disease notably cognitive, progressing
* Anxious subject (Hamilton score \> 7 and/or Spielberger score \> 51 for a man or \> 61 for a woman)
* Left-handed subject (Edinburgh Handedness inventory)
* Subject presenting a not corrected visual disease or a motor function disease that could interfere with tests realization
* Smoker
* Subject taking one or more psychotropics or apparent products
* Subject having taken, during the previous month, one or more drugs that could interfere with study drugs metabolism
* Subject drinking too much coffee or tea (\> 4 cups per day) or alcohol (\>½ liter of wine or equivalent per day)
* Subject presenting contra-indication to one of the drugs used in the study
* Subject with past history of intolerance to drugs used in the study
* Subject not capable to use the CANTAB cognitive evaluation system
* Subject which may not be able to participate to the whole study
* Subject under tutelage or guardianship
* Subject not able to well-understand French and so to understand cognitive tests
* Subject not capable to swallow capsules
* Subject participating to another study or in exclusion period (3 months after a previous trial).

Primary outcomes:
measure: Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)
timeFrame: 2 hours after the study treatment intake
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU
Study officials:
References:
citation: Deplanque D, Machuron F, Waucquier N, Jozefowicz E, Duhem S, Somers S, Colin O, Duhamel A, Bordet R. Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study. Eur Neuropsychopharmacol. 2018 Aug;28(8):925-932. doi: 10.1016/j.euroneuro.2018.05.011. Epub 2018 Jun 29.