Status:
COMPLETED
Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test
Lead Sponsor:
Orasi Medical, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
NA
Brief 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...
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. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00972985
Start Date
September 1 2009
End Date
December 1 2009
Last Update
January 13 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007