Who is eligible for clinical trial NCT07263022?

Participants must meet the protocol's inclusion criteria for Psychosis. The stated age range is 18 Years to 35 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07263022 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-22

Cognitive Strategies in Early Psychosis 2 (NCT07263022)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: University of Minnesota

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (46 items).

Location: University of Minnesota — Minneapolis, Minnesota

Age range: 18 Years to 35 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

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 as reported by the participant:
Renal impairment, injury, or disease
Hepatic impairment, injury, or disease
Myocardial infarction or heart disease, or endorsement of history of or of cardiac symptoms at intake:
Dyspnea
Palpitations
Orthopnea

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Minnesota — Minneapolis, Minnesota

📞 Contact the Study Coordinator

Phone: (612) 772-2201

Email: costep2@umn.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Psychosis

Neurobehavioral Mechanisms of Social Isolation and Loneliness in Serious Mental Illness — Charlestown, Massachusetts
Psychosis TMS Study — Charlestown, Massachusetts
Youth Nominated Support Team — Irvine, California
Trajectories of Treatment Response as Window Into the Heterogeneity of Psychosis: a Longitudinal Multimodal Imaging Study — Birmingham, Alabama
Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk — Glen Oaks, New York

Explore by condition: All Psychosis clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗