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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02147548

Enrollment

Registered

2014-05-26

Start date

2013-12-31

Completion date

2015-10-31

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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.

Interventions

DRUGetifoxine

DRUGlorazepam

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 75 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)	2 hours after the study treatment intake

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026