The Effect of Modafinil on Affective and Cognitive Processing

Study Overview
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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.

Official Title
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The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task

Conditions
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Healthy

Intervention / Treatment
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* Drug: Modafinil Oral Tablet
* Drug: Placebo Oral Tablet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modafinil group<br>a single dose of p.o. modafinil (200mg) | Drug: Modafinil Oral Tablet<br>* modafinil 200mg<br>|
| Experimental: placebo group<br>a single dose of p.o. placebo (200mg) | Drug: Placebo Oral Tablet<br>* placebo 200mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural processing during the interference processing | fMRI BOLD indices of neural processing in interference related brain regions will be compared between the treatment and placebo group. | 4h after treatment | 
| Neural processing during feedback based learning | fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment and placebo group. | 4h after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral interference performance - Response Time | Behavioral performance of interference performance for congruent and incongruent stimuli (picture vs word) will be compared between the treatment and placebo group. | 4h after treatment | 
| Behavioral interference performance - Accuracy | Behavioral performance of interference in terms of accuracy for congruent and incongruent trials (picture vs word) will be compared between the treatment and placebo group. | 4h after treatment | 
| Behavioral learning performance - Reaction time | Learning performance in terms of reaction times will be compared between the treatment and placebo group. | 4h after treatment | 
| Behavioral learning performance - Accuracy | Learning performance in terms of accuracy (learning curve, trials to reach plateau) will be compared between the treatment and placebo group. | 4h after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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modafinil, emotion, cognitive processing