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

NCT00972985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2010-01-13

No results posted yet for this study

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

Interventions

DRUG

modafinil

oral tablet, 100 mg, single acute dose

DRUG

methylphenidate

oral tablet, 20 mg, single acute dose

DRUG

lorazepam

oral tablet, 1 mg, single, acute dose

DRUG

placebo

oral tablet, single acute dose

Sponsors & Collaborators

  • Orasi Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Concetta Forchetti, MD, PhD · Alexian Brothers Neuroscience Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00972985 on ClinicalTrials.gov