Pharmacological Cognitive Enhancement (MODREST)

This study has been completed.

Sponsor:

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

History of Changes

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	Phase 0


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]


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. Other Name: Placebo
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

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.

Other Name: Placebo

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

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
Genders 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

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, see Learn About Clinical Studies.

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

No publications provided by Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Additional 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
Study First Received:	September 10, 2012
Last Updated:	September 12, 2012
Health Authority:	Italy: National Bioethics Committee

Keywords provided by Università degli Studi 'G. d'Annunzio' Chieti e Pescara:


RsfMRI, brain plasticity, cognitive enhancer

Additional relevant MeSH terms:


Armodafinil Modafinil Central Nervous System Agents Central Nervous System Stimulants	Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on February 25, 2015

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