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Pharmacological Cognitive Enhancement (MODREST)
This study has been completed.
Sponsor:
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Information provided by (Responsible Party):
Roberto Esposito, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier:
NCT01684306
First received: September 10, 2012
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Fluid Inteligence Modafinil Healthy Young Subjects Resting State Networks | Drug: Modafinil Drug: Placebo | Early Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Roberto Esposito, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:
Primary Outcome Measures:
- Acute effects of modafinil on brain resting state networks in young healthy subjects [ Time Frame: within one week ]
| Enrollment: | 26 |
| Study Start Date: | February 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Placebo
Study subjects received, in a double blind fashion, 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.
|
|
Experimental: Modafinil
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. |
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.
Other Names:
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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| Ages Eligible for Study: | 25 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01684306
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684306
Locations
| Italy | |
| Department of Neuroscience and Imaging, University "G. d'Annunzio" | |
| Chieti, Italy, 66013 | |
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Roberto Esposito, MD,Phd, Università degli Studi 'G. d'Annunzio' Chieti e Pescara |
| ClinicalTrials.gov Identifier: | NCT01684306 History of Changes |
| Other Study ID Numbers: |
MODREST_2011 |
| Study First Received: | September 10, 2012 |
| Last Updated: | September 12, 2012 |
Keywords provided by Roberto Esposito, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:
|
RsfMRI, brain plasticity, cognitive enhancer |
Additional relevant MeSH terms:
|
Modafinil Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants |
Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 17, 2017