An interventional study of modafinil and methylphenidate in Healthy, sponsored by Orasi Medical, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-13.
Sponsored by Orasi Medical, Inc. · Not applicable, Interventional, and Basic science
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.
Orasi Medical, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All healthy control subjects receive modafinil in this crossover design
Drug: modafinil
All healthy control subjects receive methylphenidate in this crossover design
Drug: methylphenidate
All healthy control subjects receive lorazepam in this crossover design
Drug: lorazepam
All healthy control subjects receive placebo in this crossover design
Drug: placebo
oral tablet, 100 mg, single acute dose
Also known as: Provigil
oral tablet, 20 mg, single acute dose
Also known as: Ritalin
oral tablet, 1 mg, single, acute dose
Also known as: Ativan
oral tablet, single acute dose
Also known as: sugar pill
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.
Time frame: The study will require 5 days for each subject. Data collection for the study is expected to require approximately 12 weeks.
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
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: 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.
Time frame: Data collection for the study is expected to require approximately 12 weeks.
The record gives a start of Sep 2009, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Modafinil · Methylphenidate · Lorazepam
Orasi Medical, Inc.