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Pharmacological Cognitive Enhancement

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684306
Acronym
MODREST
Enrollment
26
Registered
2012-09-12
Start date
2011-02-28
Completion date
2012-01-31
Last updated
2012-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Inteligence, Healthy Young Subjects, Modafinil, Resting State Networks

Keywords

RsfMRI, brain plasticity, cognitive enhancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGModafinil

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

DRUGPlacebo

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
25 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Acute effects of modafinil on brain resting state networks in young healthy subjectswithin one week

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026