The Effect of Modafinil on Affective and Cognitive Processing

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Modafinil Oral Tablet; Drug: Placebo Oral Tablet

• Registration Number: NCT03426202
• Lead Sponsor: University of Electronic Science and Technology of China

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17
• Primary Completion: 2020-01-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modafinil group	Modafinil Oral Tablet	a single dose of p.o. modafinil (200mg)
placebo group	Placebo Oral Tablet	a single dose of p.o. placebo (200mg)

Primary Outcome Measures

Name	Time	Method
Neural processing during the interference processing	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	4h after treatment	fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment and placebo group.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Life Science and Technology; 🇨🇳 Chengdu, Sichuan, China