Exploring the Effects of Diazepam and Lorazepam | RxWiki

Exploring the Effects of Diazepam and Lorazepam

Overview[ - collapse ][ - ]

Purpose	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
Condition	Healthy Subjects
Intervention	Drug: Diazepam Drug: Lorazepam Drug: placebo
Phase	N/A
Sponsor	University Hospital, Strasbourg, France
Responsible Party	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier	NCT00696033
First Received	June 9, 2008
Last Updated	September 16, 2009
Last verified	September 2009

Tracking Information[ + expand ][ + ]

First Received Date	June 9, 2008
Last Updated Date	September 16, 2009
Start Date	July 2007
Estimated Primary Completion Date	December 2008
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Exploring the Effects of Diazepam and Lorazepam
Official Title	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	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Condition	Healthy Subjects
Intervention	Drug: Diazepam Diazépam drug (0,3 mg/kg) on a single oral intake Drug: Lorazepam Lorazépam drug (0,038 mg/kg) on a single oral intake Drug: placebo lorazépam placebo or Diazépam placebo
Study Arm (s)	Experimental: 1 Oral Lorazepam Experimental: 2 Oral Diazepam Placebo Comparator: 3 Oral placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	22
Estimated Completion Date	December 2008
Estimated Primary Completion Date	December 2008
Eligibility Criteria	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
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	France

Administrative Information[ + expand ][ + ]

NCT Number	NCT00696033
Other Study ID Numbers	3777
Has Data Monitoring Committee	No
Information Provided By	University Hospital, Strasbourg, France
Study Sponsor	University Hospital, Strasbourg, France
Collaborators	Not Provided
Investigators	Principal Investigator: Pierre Vidailhet, MD Hôpitaux universitaires de strasbourg
Verification Date	September 2009

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