HealthyNCT00972985
Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test
A study testing modafinil, methylphenidate and lorazepam in people with Healthy, run by Orasi Medical, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- modafinil, methylphenidate and lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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 or food. This includes a documented or subject-verified allergy.
- Subject had an MRI 2 weeks prior to Study Day 2.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, 60007
About this study
Official title: Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- modafinil, methylphenidate, lorazepam, placebo
- Keywords
- Healthy Control subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
Also called Provigil
oral tablet, 100 mg, single acute dose
methylphenidateDrug
Also called Ritalin
oral tablet, 20 mg, single acute dose
lorazepamDrug
Also called Ativan
oral tablet, 1 mg, single, acute dose
placeboDrug
Also called sugar pill
oral tablet, single acute dose
| Study group | Role | What they receive |
|---|---|---|
| modafinil | Experimental | All healthy control subjects receive modafinil in this crossover design Receives: Drug: modafinil |
| methylphenidate | Experimental | All healthy control subjects receive methylphenidate in this crossover design Receives: Drug: methylphenidate |
| lorazepam | Experimental | All healthy control subjects receive lorazepam in this crossover design Receives: Drug: lorazepam |
| placebo | Placebo comparator | All healthy control subjects receive placebo in this crossover design Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The study will require 5 days for each subject. Data collection for the study is expected to require approximately 12 weeks.
Secondary outcomes (5)
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
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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.
Measured: Data collection for the study is expected to require approximately 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orasi Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Concetta Forchetti, MD, PhD, Principal investigator, Alexian Brothers Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972985
- Sponsor's protocol ID
- ADE 09-01
- Status last verified
- Jan 2010
- First submitted
- 4 Sep 2009
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test
- ClinicalTrials.gov ID
- NCT00972985
- Acronym / sponsor ID
- ADE 09-01
- Conditions
- Healthy
- Keywords
- Healthy Control subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Orasi Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| modafinil | Experimental | Drug: modafinilAll healthy control subjects receive modafinil in this crossover design |
| methylphenidate | Experimental | Drug: methylphenidateAll healthy control subjects receive methylphenidate in this crossover design |
| lorazepam | Experimental | Drug: lorazepamAll healthy control subjects receive lorazepam in this crossover design |
| placebo | Placebo comparator | Drug: placeboAll healthy control subjects receive placebo in this crossover design |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- Subject has normal or corrected to normal visual and auditory acuity.
Key exclusion criteria (9 listed)
- 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 or food. This includes a documented or subject-verified allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modafinilAlso: Provigiloral tablet, 100 mg, single acute dose | Drug | modafinil |
| methylphenidateAlso: Ritalinoral tablet, 20 mg, single acute dose | Drug | methylphenidate |
| lorazepamAlso: Ativanoral tablet, 1 mg, single, acute dose | Drug | lorazepam |
| placeboAlso: sugar pilloral tablet, single acute dose | Drug | placebo |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Concetta Forchetti, MD, PhD principal investigator
Alexian Brothers Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modafinil, methylphenidate and lorazepam in people with Healthy, run by Orasi Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.