NCT02147548CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Biocodex
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- All
- Accepts 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
- •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).
Arms & Interventions
etifoxine (Anxiolytic)
Experimental
etifoxine, 100 mg, a single oral intake
Intervention: etifoxine (Drug)
lorazepam
Active Comparator
lorazepam, 2 mg, a single oral intake
Intervention: lorazepam (Drug)
Placebo
Placebo Comparator
2 capsules of Placebo, a single oral intake
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Time Frame: 2 hours after the study treatment intake
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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