Trials / Completed
CompletedNCT01684306
Pharmacological Cognitive Enhancement
Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara · Academic / Other
- Sex
- Male
- Age
- 25 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2011-04-01
- Completion
- 2012-01-01
- First posted
- 2012-09-12
- Last updated
- 2012-09-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01684306. Inclusion in this directory is not an endorsement.