Clinical trial NCT01684306: Pharmacological Cognitive Enhancement
Official title: Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fluid Inteligence
Modafinil
Healthy Young Subjects
Resting State Networks
Keywords: RsfMRI, brain plasticity, cognitive enhancer
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 26
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute effects of modafinil on brain resting state networks in young healthy subjects
timeFrame: within one week
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Department of Neuroscience and Imaging, University "G. d'Annunzio"
Study officials:
References:
citation: Cera N, Tartaro A, Sensi SL. Modafinil alters intrinsic functional connectivity of the right posterior insula: a pharmacological resting state fMRI study. PLoS One. 2014 Sep 19;9(9):e107145. doi: 10.1371/journal.pone.0107145. eCollection 2014.
citation: Esposito R, Cilli F, Pieramico V, Ferretti A, Macchia A, Tommasi M, Saggino A, Ciavardelli D, Manna A, Navarra R, Cieri F, Stuppia L, Tartaro A, Sensi SL. Acute effects of modafinil on brain resting state networks in young healthy subjects. PLoS One. 2013 Jul 25;8(7):e69224. doi: 10.1371/journal.pone.0069224. Print 2013.