Cognitive Strategies in Early Psychosis 2

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Psychosis, Schizophrenia Disorder, Schizoaffective Disorder, Major Depressive Disorder With Psychotic Features, Bipolar Disorder With Psychotic Features, Psychosis NOS, Schizophreniform Disorder, Psychotic Disorder, Cognition

In brief

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

Key facts

Study ID: NCT07263022
Run by: University of Minnesota
People needed: 24
Starts: 2026-07-17
Expected to finish: 2030-04-30
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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
Pedal oedema
Significant dizziness
Syncope
Claudication
Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis
Presence of unmanaged hypertension (>140/90) or elevated resting heart rate (>100 bpm)
Abnormal clinical laboratory values:
uACR > 30 mg/g
creatinine level >0.95 mg/dL
AST or ALT > 50 U/L
Bilirubin > 1.2 mg/dL
Total Protein < 6 g/dL
Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)

Where it is running

University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.