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

Biocodex

Status and phase: Completed; Phase 3

Conditions: Healthy Volunteers

Treatments: Drug: etifoxine; Drug: lorazepam; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02147548

ETILANCE - ETI 175

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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31 participants in 3 patient groups, including a placebo group

etifoxine (Anxiolytic)

Experimental group

Description:

etifoxine, 100 mg, a single oral intake

Treatment:

Drug: etifoxine

lorazepam

Active Comparator group

Description:

lorazepam, 2 mg, a single oral intake

Treatment:

Drug: lorazepam

Placebo

Placebo Comparator group

Description:

2 capsules of Placebo, a single oral intake

Treatment:

Drug: Placebo