Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test - Full Text View

Sponsor:	Orasi Medical, Inc.
Information provided by:	Orasi Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00972985

Purpose

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.

Condition	Intervention
Healthy	Drug: modafinil Drug: methylphenidate Drug: lorazepam Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Methylphenidate Methylphenidate hydrochloride Lorazepam Modafinil

U.S. FDA Resources

Further study details as provided by Orasi Medical, Inc.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	September 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: modafinil All healthy control subjects receive modafinil in this crossover design	Drug: modafinil oral tablet, 100 mg, single acute dose Other Name: Provigil
Experimental: methylphenidate All healthy control subjects receive methylphenidate in this crossover design	Drug: methylphenidate oral tablet, 20 mg, single acute dose Other Name: Ritalin
Experimental: lorazepam All healthy control subjects receive lorazepam in this crossover design	Drug: lorazepam oral tablet, 1 mg, single, acute dose Other Name: Ativan
Placebo Comparator: placebo All healthy control subjects receive placebo in this crossover design	Drug: placebo oral tablet, single acute dose Other Name: sugar pill

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972985

Locations

United States, Illinois
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007

Sponsors and Collaborators

Orasi Medical, Inc.

Investigators

Principal Investigator:

Concetta Forchetti, MD, PhD

Alexian Brothers Neuroscience Institute

More Information

No publications provided

Responsible Party:	Todd Verdoorn, Ph.D., Chief Scientific Officer, Orasi Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00972985 History of Changes
Other Study ID Numbers:	ADE 09-01
Study First Received:	September 4, 2009
Last Updated:	January 12, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Orasi Medical, Inc.:

Healthy Control subjects

Additional relevant MeSH terms:

Lorazepam
Methylphenidate
Modafinil
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators

GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 24, 2012