MedDataX Logo

Pharmacological Cognitive Enhancement

NCT ID: NCT01684306

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Inteligence Modafinil Healthy Young Subjects Resting State Networks

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

RsfMRI, brain plasticity, cognitive enhancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Modafinil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Provigil Code name: Modafinil serial number:74507491

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Roberto Esposito

MD,Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Chieti, Italy, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25237810 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23935959 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MODREST_2011

Identifier Type: -

Identifier Source: org_study_id