NCT01272778

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Orasi Medical, Inc. · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Lorazepam	Oral capsule, 0.2 mg, single acute dose
DRUG	Lorazepam	oral capsule, 0.5 mg, single acute dose
DRUG	Lorazepam	oral capsule, 1.0 mg, single acute dose
DRUG	Lorazepam	oral capsule, 2.0 mg, single acute dose
DRUG	Placebo	oral capsule, single acute dose

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-01-10
• Last updated: 2011-01-10

Locations

1 site across 1 country: United States