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

Sponsor:

Information provided by (Responsible Party):

Roberto Esposito, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fluid Inteligence Modafinil Healthy Young Subjects Resting State Networks	Drug: Modafinil Drug: Placebo	Early Phase 1

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.

Study Design


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

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

Arms and Interventions

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: Provigil Code name: Modafinil serial number:74507491

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:

Provigil
Code name: Modafinil
serial number:74507491

Outcome Measures

Primary Outcome Measures :

Acute effects of modafinil on brain resting state networks in young healthy subjects [ Time Frame: within one week ]

Eligibility Criteria

Information from the National Library of Medicine

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

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.

Contacts and Locations

Information from the National Library of Medicine

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

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):

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.

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.


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

To Top