Cognitive Strategies in Early Psychosis 1

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

• English proficiency, as determined by staff observation and participant self-report

• Estimated IQ at or above 70, as estimated by the cognitive assessments

• Is clinical stable, defined as outpatient status for at least one month prior to study participation

• Has clinically stable doses of medication for at least one month prior to study participation as determined by the PI

‣ Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have major increases or decreases in dosses, or additions or removal of medications in the past 30 days

⁃ Participants are to have no changes to medications in the past 7 days before study medication administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Kaylee Enevold
costep1@umn.edu
612-403-4585
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 103
Treatments
Experimental: COSTEP 1
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov