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

NCT00972985 | Completed

• 1 other identifier: ADE 09-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Healthy

Keywords

Healthy Control subjects

Outcome Measures

Primary Outcomes (1)

• 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.

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

  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;

  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.

Study Arms (4)

modafinil

EXPERIMENTAL

All healthy control subjects receive modafinil in this crossover design

Drug: modafinil

methylphenidate

EXPERIMENTAL

All healthy control subjects receive methylphenidate in this crossover design

Drug: methylphenidate

lorazepam

EXPERIMENTAL

All healthy control subjects receive lorazepam in this crossover design

Drug: lorazepam

placebo

PLACEBO COMPARATOR

All healthy control subjects receive placebo in this crossover design

Drug: placebo

Interventions

modafinil DRUG

oral tablet, 100 mg, single acute dose

Also known as: Provigil

modafinil

methylphenidate DRUG

oral tablet, 20 mg, single acute dose

Also known as: Ritalin

methylphenidate

lorazepam DRUG

oral tablet, 1 mg, single, acute dose

Also known as: Ativan

lorazepam

placebo DRUG

oral tablet, single acute dose

Also known as: sugar pill

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orasi Medical, Inc.: lead

Study Sites (1)

Alexian Brothers Neuroscience Institute

Elk Grove Village, Illinois, 60007, United States

Location

MeSH Terms

Interventions

Modafinil; Methylphenidate; Lorazepam; Sugars

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Concetta Forchetti, MD, PhD

  Alexian Brothers Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (1)