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

NCT02147548 | Completed Phase 3

• 1 other identifier: ETILANCE - ETI 175
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  2 hours after the study treatment intake

Study Arms (3)

etifoxine (Anxiolytic)

EXPERIMENTAL

etifoxine, 100 mg, a single oral intake

Drug: etifoxine

lorazepam

ACTIVE COMPARATOR

lorazepam, 2 mg, a single oral intake

Drug: lorazepam

Placebo

PLACEBO COMPARATOR

2 capsules of Placebo, a single oral intake

Drug: Placebo

Interventions

etifoxine DRUG

etifoxine (Anxiolytic)

lorazepam DRUG

lorazepam

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocodex: lead

Study Sites (1)

Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU

Lille, 59037, France

Location

Related Publications (1)

• Deplanque D, Machuron F, Waucquier N, Jozefowicz E, Duhem S, Somers S, Colin O, Duhamel A, Bordet R. Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study. Eur Neuropsychopharmacol. 2018 Aug;28(8):925-932. doi: 10.1016/j.euroneuro.2018.05.011. Epub 2018 Jun 29.

  PMID: 30135030 DERIVED

MeSH Terms

Interventions

etifoxine; Lorazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

FR (1)