The Effect of Modafinil on Affective and Cognitive Processing

U

University of Electronic Science and Technology of China

Status

Unknown

Conditions

Healthy

Treatments

Drug: Modafinil Oral Tablet
Drug: Placebo Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03426202
UESTC-neuSCAN-49

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

modafinil group
Experimental group
Description:
a single dose of p.o. modafinil (200mg)
Treatment:
Drug: Modafinil Oral Tablet
placebo group
Experimental group
Description:
a single dose of p.o. placebo (200mg)
Treatment:
Drug: Placebo Oral Tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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