Not Yet RecruitingPhase 3

Cognitive Strategies in Early Psychosis 2

24 participantsStarted 2026-05-11

Plain-language summary

The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators 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 with psychosis play the brain games? * Does a single dose of d-serine change how people with psychosis play the brain games? * Does a single dose of modafinil change brain activity? * Does a single dose of d-serine 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. * Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart. * Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study. * Play brain games on a computer that measure decision making, thinking, and problem solving skills

Who can participate

Age range18 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between the ages of 18 and 35 * Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment * Estimated IQ of 70 or above * Proficient at English as determined through interactions with the study team * No change in psychiatric medication within a week of enrollment or MRI study visits * No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI/Co-Is * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days. * Participants are to have no changes to medications in the past 7 days before drug administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug). Exclusion Criteria: Medical Criteria: * Presence of the following medical concerns as determined by the study PI: * Major neurological disorder * History of a clinically significant head injury with or without prolonged unconsciousness * Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating * History of any of the following…

What they're measuring

Test My Brain - Digit Symbol Coding

Timeframe: Baseline

Test My Brain - Digit Symbol Coding

Timeframe: Day 7 (fMRI 1)

Test My Brain - Digit Symbol Coding

Timeframe: Day 36 (fMRI 2)

Test My Brain - Digit Symbol Coding

Timeframe: Day 63 (fMRI 3)

Test My Brain - Digit Symbol Coding

Timeframe: Day 91 (fMRI 4)

Test My Brain - Digit Symbol Coding

Timeframe: Day 119 (fMRI 5)

Test My Brain - Digit Symbol Coding

Timeframe: Day 147 (fMRI 6)

Test My Brain - Verbal Paired Associates Memory

Timeframe: Baseline

Test My Brain - Verbal Paired Associates Memory

Trial details

NCT IDNCT07263022

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-04-30

Contact for this trial

Freddie Holmberg Kohler

612-772-2201 costep2@umn.edu

View on ClinicalTrials.gov More Psychosis trials

Plain-language summary

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Test My Brain - Digit Symbol Coding

Timeframe: Baseline

Test My Brain - Digit Symbol Coding

Timeframe: Day 7 (fMRI 1)

Test My Brain - Digit Symbol Coding

Timeframe: Day 36 (fMRI 2)

Test My Brain - Digit Symbol Coding

Timeframe: Day 63 (fMRI 3)

Test My Brain - Digit Symbol Coding

Timeframe: Day 91 (fMRI 4)

Test My Brain - Digit Symbol Coding

Timeframe: Day 119 (fMRI 5)

Test My Brain - Digit Symbol Coding

Timeframe: Day 147 (fMRI 6)

Test My Brain - Verbal Paired Associates Memory

Timeframe: Baseline

Test My Brain - Verbal Paired Associates Memory