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Healthy Volunteers | Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly

Healthy Volunteers research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy Volunteers

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:etifoxine

Drug:lorazepam

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

etifoxine (Anxiolytic)etifoxine, 100 mg, a single oral intake

lorazepamlorazepam, 2 mg, a single oral intake

Placebo2 capsules of Placebo, a single oral intake

Study Status

Completed

Start Date: December 2013

Completed Date: October 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Biocodex

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02147548

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