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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: etifoxine
* Drug: lorazepam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etifoxine (Anxiolytic)<br>etifoxine, 100 mg, a single oral intake | Drug: etifoxine<br> <br> |
| Active Comparator: lorazepam<br>lorazepam, 2 mg, a single oral intake | Drug: lorazepam<br> <br> |
| Placebo Comparator: Placebo<br>2 capsules of Placebo, a single oral intake | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB) |  | 2 hours after the study treatment intake |