Not Yet RecruitingPhase 3

Cognitive Strategies in Early Psychosis 2

24 participantsStarted 2026-07-07

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 range

18 Years – 35 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is still listed as 'not yet recruiting' — do you know when it's expected to open for enrollment, and would it make sense for me to wait for it or to start standard treatment now?
2The study seems focused on measuring cognitive abilities like memory, processing speed, reasoning, and emotion recognition using online brain tests — does that match the kinds of cognitive difficulties I'm experiencing, and do you think cognitive improvement is the right goal to prioritize for me at this stage?
3Since this is a Phase 3 trial, which means it's testing whether the cognitive strategy intervention actually works at a larger scale, what do we know so far about how safe and effective this type of approach has been in earlier studies for people with early psychosis?
4The trial includes brain imaging to measure resting-state functional connectivity — are there any reasons, medical or practical, why going through MRI scans at multiple points could be a concern for me specifically?
5Given that this trial covers several different diagnoses — including schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, and others — how would you weigh whether this trial's approach is the right fit for my specific diagnosis compared to other treatment paths available to me right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Test My Brain - Digit Symbol Coding

Timeframe: Baseline

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Timeframe: Day 7 (fMRI 1)

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Timeframe: Day 36 (fMRI 2)

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Timeframe: Day 63 (fMRI 3)

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Timeframe: Day 91 (fMRI 4)

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Timeframe: Day 119 (fMRI 5)

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Timeframe: Day 147 (fMRI 6)

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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 range

18 Years – 35 Years

Sex

ALL

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