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Completed

NCT Number: NCT01684306

Pharmacological Cognitive Enhancement

There is growing debate on the use of drugs that can promote cognitive enhancement. Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have important side effects and may induce addiction. In our study, we will investigate the use of modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears to have less side effects compared to amphetamine-like drugs and we will analyzed whether the drug can influence cognitive performances and the brain resting state network activity of healthy young subjects.

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Key information

Conditions

Fluid Inteligence Healthy Young Subjects Modafinil Resting State Networks

Age range

25 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Neuroscience and Imaging, University "G. d'Annunzio"

Chieti, Italy, 66013

About this study

Subjects will be included in a double-blind, placebo-controlled study in which a single dose (100 mg) of modafinil will be administered. Both groups will be, before and three hours after administration of drug or placebo, tested for neuropsychological performances with the Raven's Advanced Progressive Matrices II set (APM).

Resting state functional magnetic resonance (rs-fMRI) will be also employed, before and after three hours, to study changes in the activity of resting state brain networks. Finally, with Diffusion Tensor Imaging (DTI) we will evaluate the structural connectivity of the two groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects do not meet the criteria for exclusion

Exclusion criteria

  • current signs of psychiatric, neurological or medical (hypertension, cardiac disorders, epilepsy) conditions as determined by the Millon test and by clinical examination;subjects showing visual or motor impairments. All subjects taking any psychoactive drug or having a history of alcohol abuse.

Treatment and study plan

Modafinil

Drug

Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.

Other names: Provigil, Code name: Modafinil, serial number:74507491

Placebo

Drug

Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.

Primary outcomes

  1. Acute effects of modafinil on brain resting state networks in young healthy subjects

    Time frame: within one week

Sponsors and collaborators

Lead sponsor

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Other

Registry information

Official study title

Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects

Acronym: MODREST

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 12, 2012
Registry last updated
Sep 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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