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Cognitive Strategies in Early Psychosis 2

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

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

• 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).

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Freddie Holmberg Kohler, MBS, CCRP
costep2@umn.edu
612-772-2201
Backup
Ariel Currie
curri105@umn.edu
Time Frame
Start Date: 2026-07-17
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 24
Treatments
Experimental: Arm 1: Modafinil > d-serine > placebo
Participants will take single doses three study medications in the following order: modafinil (200 mg); d-serine (100 mg/kg); and placebo. All medications will be taken 2 times (A\>B\>C\>A\>B\>C).~(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded)
Experimental: Arm 2: Modafinil > placebo > d-serine
Participants will take single doses of three study medications in the following order: modafinil (200 mg); placebo; and d-serine (100 mg/kg). All medications will be taken 2 times (A\>B\>C\>A\>B\>C).~(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded)
Experimental: Arm 3: D-serine > modafinil > placebo
Participants will take single doses of three study medications in the following order: d-serine (100 mg/kg); modafinil (200 mg); and placebo. All medications will be taken 2 times (A\>B\>C\>A\>B\>C).~(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded)
Experimental: Arm 4: D-serine > placebo > modafinil
Participants will take single doses of three study medications in the following order: d-serine (100 mg/kg); placebo; and modafinil (200 mg). All medications will be taken 2 times (A\>B\>C\>A\>B\>C).~(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded)
Experimental: Arm 5: Placebo > modafinil > d-serine
Participants will take single doses of three study medications in the following order: placebo; modafinil (200 mg); and d-serine (100 mg/kg). All medications will be taken 2 times (A\>B\>C\>A\>B\>C).~(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded)
Experimental: Arm 6: Placebo > d-serine > modafinil
Participants will take single doses of three study medications in the following order: placebo; d-serine (100 mg/kg); and modafinil (200 mg). All medications will be taken 2 times (A\>B\>C\>A\>B\>C).~(Note: This order is not necessarily reflective of the actual randomization schedule used in the protocol, as the procedure is double-blinded)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov