NCT00696033

Brief Summary

Aims :

  • exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
  • comparing lorazepam effects to diazepam (0.3 mg/kg)effects
  • exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI Hypothesis :
  • both diazepam and lorazepam will impair explicit memory performance, but lorazepam only will impair perceptual priming
  • lorazepam and diazepam will modify the normal correlates of information encoding within explicit memory
  • lorazepam only will alter the neural correlates of perceptual priming

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2009

Enrollment Period

1.4 years

First QC Date

June 9, 2008

Last Update Submit

September 4, 2025

Conditions

Healthy Subjects

Keywords

BenzodiazepinesLorazepamDiazepamMemoryPerceptual primingFunctional brain imagingFMRI

Outcome Measures

Primary Outcomes (1)

  • Exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI

    After a single oral intake

Secondary Outcomes (2)

  • Comparing lorazepam effects to diazepam (0.3 mg/kg)effects

    After a single oral intake

  • Exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI

    After single oral intake

Study Arms (3)

1

EXPERIMENTAL

Oral Lorazepam

Drug: Lorazepam

2

EXPERIMENTAL

Oral Diazepam

Drug: Diazepam

3

PLACEBO COMPARATOR

Oral placebo

Drug: placebo

Interventions

DiazepamDRUG

Diazépam drug (0,3 mg/kg) on a single oral intake

2
LorazepamDRUG

Lorazépam drug (0,038 mg/kg) on a single oral intake

1
placeboDRUG

lorazépam placebo or Diazépam placebo

3

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects between 18 and 30 years
  • Students in medicine, dentistry or pharmacy
  • French as a mother language

You may not qualify if:

  • Medical condition influencing brain function (neurological or psychiatric)
  • Asthma
  • General anesthesia in the 3 last months
  • Drug addiction (DSM IV criteria)
  • Regular medical treatment (except contraceptive pill)
  • Significant impairment observed during a medical examination including ECG
  • Intake of any psychotropic drug that can have a effect during testing
  • IQ (Wechsler) \< 100
  • FMRI contra-indication (implantable magnetic material, claustrophobia)
  • Known allergy to benzodiazepine or lactose
  • \> 10 cigarettes/day
  • Pregnant or breast-feeding woman
  • No health insurance
  • Subjects who do not complete the entire study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'investigation clinique, hôpital civil

Strasbourg, 67091, France

Location

Clinique psychiatrique, hôpital civil

Strasbourg, 67091, France

Location

MeSH Terms

Interventions

DiazepamLorazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pierre Vidailhet, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 11, 2025

Record last verified: 2009-09

Locations

FR(2)