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

Information source: Biocodex
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: etifoxine (Drug); lorazepam (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Biocodex

Overall contact:
Pr DEPLANQUE Dominique, MD, PhD, Phone: 0033320445449


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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

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


Minimum age: 65 Years. Maximum age: 75 Years. Gender(s): Both.


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,


- 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).

Locations and Contacts

Pr DEPLANQUE Dominique, MD, PhD, Phone: 0033320445449

Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU, Lille 59037, France; Recruiting
DEPLANQUE Dominique, MD, PhD, Phone: 0033320445449, Email: dominique.deplanque@chru-lille.fr
DEPLANQUE Dominique, MD, PhD, Principal Investigator
Additional Information

Starting date: December 2013
Last updated: February 26, 2015

Page last updated: August 23, 2015

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