NCT07231497

Cognitive Strategies in Early Psychosis 1

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Participants will be asked to complete two appointments in this study. These appointments will ideally be about 1 week apart, but can be up to 1 month apart if needed. The first appointment is the Intake and Clinical appointment. This visit will take between 30 minutes to 2.5 hours, depending on how many study tasks are needed. Participants in this study may have participated in a sister study, called "State Representation in Early Psychosis 2 (STEP 2)." If so, they will not need to complete many of the intake questionnaires, and it is expected to take about 30 minutes for them to complete this appointment. If they did not participate in STEP 2, participants will need to complete the full intake battery. During the interview, the investigators will ask questions about a participant's medical and psychiatric history, and current and past mental health symptoms. The investigators will collect demographics, as well as information on the person's social life and quality of life. After the interview, they will complete brain games on their computer. The second appointment is the EEG + Medication appointment. Participants will come in person to the MHealth Fairview Riverside Campus. The visit will take place in the University of Minnesota Department of Psychiatry. This visit will take about 4-4.5 hours. First, the investigators will complete safety screening measures. This will include: * A blood draw for lab testing. They will collect one 3mL tube, which is less than ⅔ of a teaspoon. * A blood pressure reading. * A breathalyzer to test for the presence of alcohol. * A urine drug test to screen for the presence of substances. * If pregnancy is a physical possibility, a urine pregnancy test will be required. After screening measures are successfully completed, the investigators will fit an EEG cap onto the participant's head. While this is happening, the participant will complete self-report questionnaires. Once the cap is in place, the participant will play some brain games. After this, the participant will take a single dose of modafinil. The participant will be provided with a meal while the modafinil metabolizes. Afterwards, they will monitor the participant's vital signs and ask whether they are experiencing any adverse effects. After the observation period is completed, the participant will complete the same brain games on the computer. The investigators will take another vital signs measurement and ask about adverse effects. The following day, the investigators will contact the participant via phone to ask whether they experienced any adverse effects after leaving the study appointment. This call should last about 5 minutes.

Conditions

• Cognition
• Healthy Participants

Interventions

Type	Name	Description
DRUG	Modafinil	Single dose of 200mg

Timeline

• Start date: 2025-10-31
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2025-11-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study