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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorazepam 0.2 mg | Experimental | All subjects receive lorazepam 0.2 mg in this crossover design. |
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| Lorazepam, 0.5 mg | Experimental | All subjects receive lorazepam 0.5 mg in this crossover design. |
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| Lorazepam, 1.0 mg | Experimental | All subjects receive lorazepam 1.0 mg in this crossover design. |
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| Lorazepam, 2.0 mg | Experimental | All subjects receive lorazepam 2.0 mg in this crossover design |
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| Sugar pill | Placebo Comparator | All subjects receive a sugar pill in this crossover design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorazepam | Drug | Oral capsule, 0.2 mg, single acute dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Kay, MA | Contact | 847-981-3570 | christina.kay@abbhh.net | |
| Donnell Carmichael, PsyD | Contact | 847-981-5771 | donnell.carmichael@abbhh.net |
| Name | Affiliation | Role |
|---|---|---|
| Concetta Forchetti, MD, PhD | Alexian Brothers Neurosciences Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexian Brothers Neurosciences Institute | Recruiting | Elk Grove Village | Illinois | 60007 | United States |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Lorazepam |
| Drug |
oral capsule, 0.5 mg, single acute dose |
|
| Lorazepam | Drug | oral capsule, 1.0 mg, single acute dose |
|
| Lorazepam | Drug | oral capsule, 2.0 mg, single acute dose |
|
| Placebo | Drug | oral capsule, single acute dose |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |