Actively Recruiting
Cognitive Strategies in Early Psychosis 1
Led by University of Minnesota · Updated on 2026-02-17
103
Participants Needed
1
Research Sites
234 weeks
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
The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They hope to improve our understanding of psychosis to help people in the future. The main research questions are: Does a single dose of modafinil change how people play the brain games? Does a single dose of modafinil change brain activity? Participants will: Complete an interview and self-report questionnaires. Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test. Take a single dose of modafinil. Complete brain games while wearing an electroencephalography (EEG) cap, before and after taking the single dose of modafinil. EEG measures electrical activity in the brain.
CONDITIONS
Official Title
Cognitive Strategies in Early Psychosis 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Proficient in English as determined by staff and self-report
- Estimated IQ of 70 or above based on cognitive assessments
- Clinically stable outpatient for at least one month before participation
- Stable medication doses for at least one month prior, with no major changes or new medications in the past 30 days
- No medication changes in the 7 days before receiving study drug
You will not qualify if you...
- Major neurological disorders or history of head injury with or without prolonged unconsciousness
- Major medical conditions posing risk or impeding study participation, including renal or hepatic impairment and heart disease
- Cardiac symptoms such as dyspnea, palpitations, orthopnea, pedal edema, significant dizziness, syncope, or claudication
- Low white blood cell count or related diagnoses like leukopenia, neutropenia, or agranulocytosis
- Unmanaged hypertension (>140/90) or resting heart rate over 100 bpm
- Abnormal lab values: uACR > 30 mg/g, creatinine > 0.95 mg/dL, AST or ALT > 50 U/L, bilirubin > 1.2 mg/dL, total protein < 6 g/dL
- Pregnancy, planning pregnancy, or breastfeeding
- Visual acuity worse than 20/25 on Snellen test
- Use of medications/supplements with major interactions with modafinil
- Allergy to modafinil or current use of modafinil
- History of Stevens-Johnson syndrome from medication
- Severe substance or alcohol use disorder within 3 months
- Lifetime stimulant use disorder
- Clinical risk of suicidal behavior or recent suicide attempt
- Recent depressive episode or severe depression
- Diagnosis or family history of psychotic, bipolar, or autism spectrum disorders
- Use of psychotropic medications or supplements with psychotropic effects
- Other psychiatric conditions or symptoms posing risk or impeding participation
- Unable or unwilling to consent or demonstrate decision-making capacity
- Illiteracy
- Significant cognitive training in the past year as judged by the PI
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
K
Kaylee Enevold
CONTACT
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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