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Trial record 54 of 239 for:    (armodafinil)

The Effect of Modafinil on Affective and Cognitive Processing

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ClinicalTrials.gov Identifier: NCT03426202
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Becker, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Modafinil Oral Tablet Drug: Placebo Oral Tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: modafinil group
a single dose of p.o. modafinil (200mg)
Drug: Modafinil Oral Tablet
modafinil 200mg

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




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Behavioral interference performance - Response Time [ Time Frame: 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.

  2. Behavioral interference performance - Accuracy [ Time Frame: 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.

  3. Behavioral learning performance - Reaction time [ Time Frame: 4h after treatment ]
    Learning performance in terms of reaction times will be compared between the treatment and placebo group.

  4. Behavioral learning performance - Accuracy [ Time Frame: 4h after treatment ]
    Learning performance in terms of accuracy (learning curve, trials to reach plateau) will be compared between the treatment and placebo group.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426202


Locations
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China, Sichuan
School of Life Science and Technology Recruiting
Chengdu, Sichuan, China, 611731
Contact: Weihua Zhao    18780247797    zarazhao.uestc@outlook.com   
Sponsors and Collaborators
University of Electronic Science and Technology of China

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Responsible Party: Benjamin Becker, Professor, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT03426202     History of Changes
Other Study ID Numbers: UESTC-neuSCAN-49
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benjamin Becker, University of Electronic Science and Technology of China:
modafinil
emotion
cognitive processing

Additional relevant MeSH terms:
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Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action