The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Neural processing during the interference processing
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
placebo group
a single dose of p.o. placebo (200mg)
Intervention: Placebo Oral Tablet (Drug)
modafinil group
a single dose of p.o. modafinil (200mg)
Intervention: Modafinil Oral Tablet (Drug)
Outcomes
Primary Outcomes
Neural processing during the interference processing
Time Frame: 4h after treatment
fMRI BOLD indices of neural processing in interference related brain regions will be compared between the treatment and placebo group.
Neural processing during feedback based learning
Time Frame: 4h after treatment
fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment and placebo group.
Secondary Outcomes
- Behavioral interference performance - Response Time(4h after treatment)
- Behavioral interference performance - Accuracy(4h after treatment)
- Behavioral learning performance - Accuracy(4h after treatment)
- Behavioral learning performance - Reaction time(4h after treatment)
Investigators
Benjamin Becker
Professor
University of Electronic Science and Technology of China