NCT01684306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2011

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

September 10, 2012

Last Update Submit

September 12, 2012

Conditions

Fluid InteligenceModafinilHealthy Young SubjectsResting State Networks

Keywords

RsfMRI, brain plasticity, cognitive enhancer

Outcome Measures

Primary Outcomes (1)

  • Acute effects of modafinil on brain resting state networks in young healthy subjects

    within one week

Study Arms (2)

Placebo

EXPERIMENTAL

Study subjects received, in a double blind fashion, a placebo pill identical to the drug.

Drug: Placebo

Modafinil

EXPERIMENTAL

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

Interventions

ModafinilDRUG

Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.

Also known as: Provigil, Code name: Modafinil, serial number:74507491
Modafinil
PlaceboDRUG

Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.

Placebo

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience and Imaging, University "G. d'Annunzio"

Chieti, Italy, 66013, Italy

Location

Related Publications (2)

  • 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.

    PMID: 25237810DERIVED

  • 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.

    PMID: 23935959DERIVED

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Phd

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 12, 2012

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

January 1, 2012

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

IT(1)