NCT03426202

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

February 1, 2018

Last Update Submit

June 14, 2019

Conditions

Keywords

modafinilemotioncognitive processing

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Behavioral interference performance - Response Time

    4h after treatment

  • Behavioral interference performance - Accuracy

    4h after treatment

  • Behavioral learning performance - Reaction time

    4h after treatment

  • Behavioral learning performance - Accuracy

    4h after treatment

Study Arms (2)

modafinil group

EXPERIMENTAL

a single dose of p.o. modafinil (200mg)

Drug: Modafinil Oral Tablet

placebo group

EXPERIMENTAL

a single dose of p.o. placebo (200mg)

Drug: Placebo Oral Tablet

Interventions

modafinil 200mg

modafinil group

placebo 200mg

placebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without past or current psychiatric or neurological disorders
  • Non-smokers
  • Right-handedness

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Life Science and Technology

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 8, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

June 17, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations