Pharmacological Cognitive Enhancement (MODREST)

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

Status and phase: Completed; Early Phase 1

Conditions: Fluid Inteligence; Healthy Young Subjects; Modafinil; Resting State Networks

Treatments: Drug: Placebo; Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT01684306

MODREST_2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Male

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Placebo

Experimental group

Description:

Study subjects received, in a double blind fashion, a placebo pill identical to the drug.

Treatment:

Drug: Placebo

Modafinil

Experimental group

Description:

Modafinil (Provigil), a drug on the market since 1997, is employed for the treatment of narcolepsy and other sleep disorders. In recent years, modafinil has also been used off-label to treat cognitive dysfunction in psychiatric disorders such as schizophrenia and Attention Deficit/Hyperactivity Disorder (ADHD). Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil.

Treatment:

Drug: Modafinil