Exploring the Effects of Diazepam and Lorazepam - Tabular View

Tracking Information

First Received Date ^ICMJE

June 9, 2008

Last Updated Date

September 16, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: After a single oral intake ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 [ Time Frame: After a single oral intake ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00696033 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparing lorazepam effects to diazepam (0.3 mg/kg)effects [ Time Frame: After a single oral intake ] [ Designated as safety issue: No ]
Exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI [ Time Frame: After single oral intake ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Exploring the Effects of Diazepam and Lorazepam

Official Title ^ICMJE

Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

Condition ^ICMJE

Healthy Subjects

Intervention ^ICMJE

Drug: Diazepam
Drug: Lorazepam
Drug: placebo

Study Arms / Comparison Groups

Experimental: Oral Lorazepam
Experimental: Oral Diazepam
Placebo Comparator: Oral placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion criteria:

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

Gender

Both

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00696033

Responsible Party

Christine GEILLER, directeur Adjoint, University Hospital, Strasbourg, France

Study ID Numbers ^ICMJE

3777

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Pierre Vidailhet, MD

Hôpitaux universitaires de strasbourg

Information Provided By

University Hospital, Strasbourg, France

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP