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This placebo-controlled crossover study is intended to measure the effect of three, common neuroactive medications 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 15 healthy volunteers over 4 study days. Subjects will receive placebo on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1 mg lorazepam p.o. on remaining study days. Medication administration will be randomized according to study day so that each subject will receive the medications in random order. 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. Cognition testing will be performed at pre-medication baseline and immediately after each post-medication scan time. This study will test the hypothesis that changes in brain functional activity can be accurately measured in healthy volunteer subjects after single, acute doses of modafinil, methylphenidate and lorazepam.
This study uses a placebo-controlled, crossover design to investigate the effect of modafinil (100 mg, p.o.), methylphenidate (20 mg, p.o.), and lorazepam (1 mg, p.o.) in 15 healthy male volunteers. The acute effect of the medications will be measured by MEG, EEG and simple cognition testing. Study procedures will be performed over 5 separate days. During an initial screening visit, Study Day 1, subjects will consent to enroll and undergo clinical evaluation sufficient to determine they are eligible to participate in the study. Upon qualification and enrollment, subjects will be randomly assigned to receive either placebo or one of the active medications on Study Days 2 - 5. Medications or placebo will be administered orally. Subjects will arrive at the MEG center in the morning on Study Day 2 and baseline MEG and EEG scans will be performed along with baseline cognition testing. The medication or placebo will be administered immediately following the baseline scans and cognition testing. Additional MEG and EEG scans will be conducted 2, 4, and 6 hours after medication or placebo administration. On Study Days 3 - 5, subjects will undergo identical procedures but will be crossed over to receive the alternate medication or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modafinil | Experimental | All healthy control subjects receive modafinil in this crossover design |
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| methylphenidate | Experimental | All healthy control subjects receive methylphenidate in this crossover design |
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| lorazepam | Experimental | All healthy control subjects receive lorazepam in this crossover design |
|
| placebo | Placebo Comparator | All healthy control subjects receive placebo in this crossover design |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modafinil | Drug | oral tablet, 100 mg, single acute dose |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of the study will be identification and characterization of a pattern of synchronous brain activity that is specifically altered by administration of active medications compared to pre-medication baseline and placebo. | The study will require 5 days for each subject. Data collection for the study is expected to require approximately 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Data collection for the study is expected to require approximately 12 weeks. | |
| Standard frequency-domain and time-domain analysis of EEG data to generate direct comparisons between MEG and EEG results; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Concetta Forchetti, MD, PhD | Alexian Brothers Neuroscience Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexian Brothers Neuroscience Institute | Elk Grove Village | Illinois | 60007 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2011 | |
| Reset | Apr 15, 2011 | |
| Release | Apr 26, 2011 |
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| methylphenidate | Drug | oral tablet, 20 mg, single acute dose |
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| lorazepam | Drug | oral tablet, 1 mg, single, acute dose |
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| placebo | Drug | oral tablet, single acute dose |
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| Data collection for the study is expected to require approximately 12 weeks. |
| Orasi will apply its data analysis technology to the EEG data in an effort to compare the time-domain correlations measured by EEG to those measured with MEG; | Data collection for the study is expected to require approximately 12 weeks. |
| Orasi will compare the pattern of cross-correlations observed with medications to those observed in our database of healthy and disease subjects; | Data collection for the study is expected to require approximately 12 weeks. |
| The results of standard cognitive tests designed to identify the known effects of medications. | Data collection for the study is expected to require approximately 12 weeks. |
| Reset | May 23, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2011 | Apr 15, 2011 | |||
| Apr 26, 2011 | May 23, 2011 |
| ID | Term |
|---|---|
| D000077408 | Modafinil |
| D008774 | Methylphenidate |
| D008140 | Lorazepam |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002241 | Carbohydrates |
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