Pharmacological Cognitive Enhancement

Modafinil Clinical Trial

— MODREST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684306
• Other study ID #: MODREST_2011
• Status: Completed
• Phase: Phase 0
• First received: September 10, 2012
• Last updated: September 12, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Neuroscience and Imaging, University "G. d'Annunzio"	Chieti

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute effects of modafinil on brain resting state networks in young healthy subjects		within one week	No