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

July 26, 2016 updated by: Biocodex

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocodex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETILANCE - ETI 175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe