Actively Recruiting
Cognitive Strategies in Early Psychosis 1: Evaluating Single-Dose Modafinil Effects on Brain Activity and Decision Making
Led by University of Minnesota · Updated on 2026-02-17
103
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying decision making in psychosis spectrum disorders, such as schizophrenia, by evaluating how a single dose of modafinil affects brain activity and performance on brain games. This study aims to improve understanding of psychosis to help future patients. It is a phase 3 interventional trial involving healthy participants aged 18 to 35. Participants will attend two appointments about one week apart. The first visit includes an interview, questionnaires, and brain games on a computer. The second visit involves safety screening, wearing an EEG cap to measure brain activity, playing brain games before and after taking a single 200mg dose of modafinil, and monitoring vital signs. Participants will also receive a meal during the modafinil metabolism period and be contacted by phone the next day for follow-up on any side effects. During the study, participants complete interviews about their medical and psychiatric history and quality of life. Assessments include blood draws, urine drug and pregnancy tests, alcohol breathalyzer, and EEG recordings. Outcome measures focus on performance changes in various brain games and brain activity via EEG. Safety is monitored through vital signs and follow-up calls. Total participation involves two visits and a phone call, with tasks lasting from 30 minutes up to 4.5 hours per session.
CONDITIONS
Brief Title
Cognitive Strategies in Early Psychosis 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must speak and understand English
- Estimated IQ of 70 or higher
- Clinically stable outpatient for at least one month prior to participation
- Clinically stable medication doses for at least one month prior to study participation
- No major medication changes in the 7 days before receiving study medication
You will not qualify if you...
- Major neurological disorder or history of significant head injury
- Major medical conditions that increase risk or impede study participation
- History of kidney, liver, or heart disease
- Cardiac symptoms like breathing difficulty, palpitations, or dizziness needing medical follow-up
- Low white blood cell count or related blood disorders
- Unmanaged high blood pressure or elevated resting heart rate
- Abnormal lab values for kidney, liver, or protein tests
- Pregnant, planning pregnancy, or breastfeeding
- Cannot pass visual acuity test (less than 20/25)
- Taking medications or supplements with major interactions with modafinil
- Allergy to modafinil or currently prescribed modafinil
- History of Stevens-Johnson syndrome from medication
- Severe substance or alcohol use disorder within past 3 months
- Lifetime stimulant use disorder
- Clinical risk of suicidal behavior or recent suicide attempts
- Recent severe depressive episode
- Diagnosis or family history of psychotic, bipolar, or autism spectrum disorders
- Taking psychotropic medications or supplements
- Other psychiatric conditions that impede participation
- Unable or unwilling to provide informed consent or demonstrate decision-making capacity
- Illiteracy
- Significant cognitive training in past year that may affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 30 minutes to 2.5 hours
Participants complete intake questionnaires and interviews about medical and psychiatric history, mental health symptoms, demographics, social life, and quality of life. They also complete brain games on a computer.
1 visit (in-person)
Duration - About 4 to 4.5 hours
Participants undergo safety screening including blood draw, blood pressure, breathalyzer, urine drug test, and pregnancy test if applicable. An EEG cap is fitted, followed by brain games and self-report questionnaires. Participants then take a single dose of modafinil and are observed while the medication metabolizes, including vital signs monitoring and adverse effects assessment. Afterward, participants complete the same brain games and have final vital signs and adverse effects assessed.
1 visit (in-person)
Duration - Approximately 5 minutes
The day after the EEG and medication appointment, participants receive a phone call to check for any adverse effects experienced after leaving the study appointment.
1 phone call
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
K
Kaylee Enevold
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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