Exploring the Effects of Diazepam and Lorazepam
Information source: University Hospital, Strasbourg, France
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Diazepam (Drug); Lorazepam (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Strasbourg, France Official(s) and/or principal investigator(s):
Pierre Vidailhet, MD, Principal Investigator, Affiliation: Hôpitaux universitaires de strasbourg
Overall contact:
Pierre Vidailhet, MD, Phone: 33.3.88.11.62.15, Email: pierre.vidailhet@chru-strasbourg.fr
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 wthin
explicit memory
- lorazepam only will alter the neural corraltes of perceptual priming
Clinical Details
Official title: Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers
Study design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Primary outcome: 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
Secondary outcome: Comparing lorazepam effects to diazepam (0.3 mg/kg)effectsExploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy subjects between 18 and 30
- Students in medicine, dentistery or pharmacy
- French as a mother language
Exclusion criteria:
- Medical condition influencing brain function (neurological or psychiatric)
- Asthma
- General anaesthesia 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
Locations and Contacts
Pierre Vidailhet, MD, Phone: 33.3.88.11.62.15, Email: pierre.vidailhet@chru-strasbourg.fr
Clinique psychiatrique, hôpital civil, Strasbourg 67091, France; Recruiting
Pierre Vidailhet, MD, Phone: 33.3.88.11.62.15, Email: pierre.vidailhet@chru-strasbourg.fr
Pierre Vidailhet, MD, Principal Investigator
Jean-marie Danion, MD, Sub-Investigator
Jack Foucher, MD, Sub-Investigator
Anne Giersch, MD, Sub-Investigator
Pascal Bousquet, MD, Sub-Investigator
Centre d'investigation clinique, hôpital civil, Strasbourg 67091, France; Recruiting
Pascal Bousquet, MD, Phone: 33.3.88.11.62.15, Email: pascal.bousquet@chru-strasbourg.frine.u-strasbg.fr
Additional Information
Starting date: July 2007
Ending date: September 2008
Last updated: June 17, 2008
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