Pharmacological Cognitive Enhancement (MODREST)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01684306 |
Recruitment Status
:
Completed
First Posted
: September 12, 2012
Last Update Posted
: September 13, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fluid Inteligence Modafinil Healthy Young Subjects Resting State Networks | Drug: Modafinil Drug: Placebo | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
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 |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | January 2012 |
Arm | Intervention/treatment |
---|---|
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:
|
- Acute effects of modafinil on brain resting state networks in young healthy subjects [ Time Frame: within one week ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684306
Italy | |
Department of Neuroscience and Imaging, University "G. d'Annunzio" | |
Chieti, Italy, 66013 |
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 |
First Posted: | September 12, 2012 Key Record Dates |
Last Update Posted: | September 13, 2012 |
Last Verified: | September 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 |