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OpenTrials
Completed

NCT Number: NCT02147548

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

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.

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Key information

Conditions

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU

Lille, 59037, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Etifoxine

Drug

Lorazepam

Drug

Placebo

Drug

Primary outcomes

  1. Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)

    Time frame: 2 hours after the study treatment intake

Sponsors and collaborators

Lead sponsor

Biocodex

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 26, 2014
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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