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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147548
• Other study ID #: ETILANCE - ETI 175
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2014
• Last updated: July 26, 2016
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Biocodex
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• etifoxine

• lorazepam

• Placebo

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Biocodex

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)		2 hours after the study treatment intake	No