- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03426202
The Effect of Modafinil on Affective and Cognitive Processing
June 14, 2019 updated by: Benjamin Becker, University of Electronic Science and Technology of China
The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- School of Life Science and Technology
-
Contact:
- Weihua Zhao
- Phone Number: 18780247797
- Email: zarazhao.uestc@outlook.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: modafinil group
a single dose of p.o. modafinil (200mg)
|
modafinil 200mg
|
Experimental: placebo group
a single dose of p.o. placebo (200mg)
|
placebo 200mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4h after treatment
|
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.
|
4h after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4h after treatment
|
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.
|
4h after treatment
|
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.
|
4h after treatment
|
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.
|
4h after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
February 6, 2018
First Posted (Actual)
February 8, 2018
Study Record Updates
Last Update Posted (Actual)
June 17, 2019
Last Update Submitted That Met QC Criteria
June 14, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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