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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biocodex
• Treatments: Etifoxine; Lorazepam

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).