Acute Effect of Lorazepam on Brain Activity Measured by Magnetoencephalograpy (MEG) and Electroencephalography (EEG)

Healthy Subjects Clinical Trial

Official title:

Acute Effect of Four Doses of Lorazepam on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction™ Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01272778
• Other study ID #: ADE-LDR 10-02
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2011
• Last updated: January 7, 2011
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2011
• Source: Orasi Medical, Inc.
• Contact: Christina Kay, MA
• Phone: 847-981-3570
• Email: christina.kay[@]abbhh.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This placebo-controlled crossover study is intended to measure the effect of four doses of lorazepam on brain activity measured by magnetoencephalography (MEG) and electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple cognition testing on 16 healthy male volunteers. On each of five study days subjects will be randomized to receive either 0.2, 0.5, 1.0 or 2.0 mg lorazepam or placebo. Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to medication administration and 2, 4, and 6 hours after medication administration. Blood samples to determine medication levels and cognition testing will be performed at pre-medication baseline and immediately after each post-medication scan time. Data will be analyzed to identify changes in brain activity compared to baseline and placebo administration using both standard approaches and the Orasi Synchronous Neural Interaction® (SNI) test. This study will test the hypothesis that dose-response changes in brain functional activity can be accurately measured by MEG/EEG in healthy volunteer subjects after single, acute doses of lorazepam.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Subject is male between 18 and 35 years of age at the time of screening.

• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

• Subject is a non-smoker.

• Subject is judged to be in good health based on medical history and brief physical examination and electrocardiogram.

• Subject has normal or corrected to normal visual and auditory acuity.

• Subject agrees to refrain from caffeine 24 hours prior to and then throughout each Study Day.

• Subject agrees to refrain from using alcohol for 48 hours prior to and then throughout each Study Day.

Exclusion Criteria:

• Subject has a diagnosis of a significant neurological condition including Alzheimer's disease, Parkinson's disease, vascular dementia, Lewy body dementia or frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, or severe traumatic brain injury.

• Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.

• Subject has a history of seizures, epilepsy, stroke, peripheral neuropathy, head trauma with persistent post-concussive symptoms, ADHD, dyslexia or other clinically significant neurological disease or cognitive impairment.

• Subject has a lifetime or current history of alcohol or substance abuse/dependence.

• Subject has a history of multiple or severe allergies, or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs. This includes a documented or subject-verified allergy.

• Subject had an MRI 2 weeks prior to Study Day 2.

• Subject has metal braces or pacemaker that may interfere with the MEG scan.

• Subject is unable to complete the MEG scan procedure.

• The investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Lorazepam
Oral capsule, 0.2 mg, single acute dose
• Lorazepam
oral capsule, 0.5 mg, single acute dose
• Lorazepam
oral capsule, 1.0 mg, single acute dose
• Lorazepam
oral capsule, 2.0 mg, single acute dose
• Placebo
oral capsule, single acute dose

Locations

Country	Name	City	State
United States	Alexian Brothers Neurosciences Institute	Elk Grove Village	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Orasi Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlated Brain Activity using MEG and SNI analysis	The identification and characterization of a pattern of synchronous brain activity that is specifically altered by administration of ascending doses of lorazepam compared to pre-medication baseline and placebo	2 hours after dosing with lorazepam	No
Secondary	Correlated Brain Activity using MEG and standard analyses	Standard frequency-domain analysis of the MEG data to identify and quantify medication-induced changes in signal power in particular frequency bands associated with brain functional activity	2 hours after dosing with lorazepam	No