HealthyNCT03426202
The Effect of Modafinil on Affective and Cognitive Processing
A study testing Modafinil Oral Tablet in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Modafinil Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
- Non-smokers
- Right-handedness
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology
Chengdu, Sichuan, 611731
Weihua Zhao, 18780247797, zarazhao.uestc@outlook.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Modafinil Oral Tablet, Placebo Oral Tablet
- Keywords
- modafinil, emotion, cognitive processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modafinil Oral TabletDrug
modafinil 200mg
Placebo Oral TabletDrug
placebo 200mg
| Study group | Role | What they receive |
|---|---|---|
| modafinil group | Experimental | a single dose of p.o. modafinil (200mg) Receives: Drug: Modafinil Oral Tablet |
| placebo group | Experimental | a single dose of p.o. placebo (200mg) Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4h after treatment
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.
Measured: 4h after treatment
Secondary outcomes (4)
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.
Measured: 4h after treatment
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.
Measured: 4h after treatment
Behavioral learning performance - Reaction time
Learning performance in terms of reaction times will be compared between the treatment and placebo group.
Measured: 4h after treatment
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.
Measured: 4h after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426202
- Sponsor's protocol ID
- UESTC-neuSCAN-49
- Status last verified
- Jun 2019
- First submitted
- 1 Feb 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task
- ClinicalTrials.gov ID
- NCT03426202
- Acronym / sponsor ID
- UESTC-neuSCAN-49
- Conditions
- Healthy
- Keywords
- modafinil, emotion, cognitive processing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modafinil group | Experimental | Drug: Modafinil Oral Tableta single dose of p.o. modafinil (200mg) |
| placebo group | Experimental | Drug: Placebo Oral Tableta single dose of p.o. placebo (200mg) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
- Non-smokers
- Right-handedness
Key exclusion criteria (6 listed)
- Medical or psychiatric illness
- Allergy against medications or general strong allergies
- Sleep disorders
- High blood pressure, general cardio-vascular alterations
- History of head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil Oral Tabletmodafinil 200mg | Drug | modafinil group |
| Placebo Oral Tabletplacebo 200mg | Drug | placebo group |
Primary outcome
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.
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.
4 secondary outcomes
Behavioral interference performance - Response Time
Time frame: 4h after treatment
Behavioral interference performance - Accuracy
Time frame: 4h after treatment
Behavioral learning performance - Reaction time
Time frame: 4h after treatment
Behavioral learning performance - Accuracy
Time frame: 4h after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modafinil Oral Tablet in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural processing during the interference processing (time frame: 4h after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.