The Effect of Modafinil on Affective and Cognitive Processing

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426202
• Other study ID #: UESTC-neuSCAN-49
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2019
• Source: University of Electronic Science and Technology of China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Modafinil Oral Tablet
modafinil 200mg
• Placebo Oral Tablet
placebo 200mg

Locations

Country	Name	City	State
China	School of Life Science and Technology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Behavioral learning performance - Reaction time	Learning performance in terms of reaction times will be compared between the treatment and placebo group.	4h after treatment
Secondary	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