The Effect of Modafinil on Affective and Cognitive Processing

NCT ID: NCT03426202

Last Updated: 2019-06-17

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-07-01

Brief Summary

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The study aims to examine whether a single dose of modafinil (200mg, p.o.) can affect feedback-based learning and interference processing in healthy male subjects.

Detailed Description

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Based on previous animal and human research suggesting a catecholamine-mediated, potentially pro-cognitive, mechanism of action of modafinil, the present study seeks to explore effects of modafinil on feedback-based learning and interference processing in healthy subjects. To this end, the present randomized double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment plans to determine the behavioral and neural effects of a single dose of p.o.modafinil (200mg) versus placebo on validated feedback-based learning and emotional/non-emotional cognitive conflict paradigms. To control for potential effects of pre-medication personality traits as well as effects of modafinil on subjective task performance, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of meta-cognitive confidence estimation.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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modafinil group

a single dose of p.o. modafinil (200mg)

Group Type EXPERIMENTAL

Modafinil Oral Tablet

Intervention Type DRUG

modafinil 200mg

placebo group

a single dose of p.o. placebo (200mg)

Group Type EXPERIMENTAL

Placebo Oral Tablet

Intervention Type DRUG

placebo 200mg

Interventions

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Modafinil Oral Tablet

modafinil 200mg

Intervention Type DRUG

Placebo Oral Tablet

placebo 200mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects without past or current psychiatric or neurological disorders
* Non-smokers
* Right-handedness

Exclusion Criteria

* Medical or psychiatric illness
* Allergy against medications or general strong allergies
* Sleep disorders
* High blood pressure, general cardio-vascular alterations
* History of head injury
* Visual or motor impairments
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Becker

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Life Science and Technology

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Weihua Zhao

Role: primary

18780247797

Other Identifiers

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UESTC-neuSCAN-49

Identifier Type: -

Identifier Source: org_study_id

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