Cognitive Strategies in Early Psychosis 2

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

Conditions

• Psychosis
• Schizophrenia Disorder
• Schizoaffective Disorder
• Major Depressive Disorder With Psychotic Features
• Bipolar Disorder With Psychotic Features
• Psychosis NOS
• Schizophreniform Disorder
• Psychotic Disorder
• Cognition

Interventions

DRUG

Modafinil

Single dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind.

DRUG

D-serine solution

Single dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind.

DRUG

Placebo

Single dose of oral placebo, in both capsule and oral solution

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Minnesota

  lead OTHER

Principal Investigators

• Sophia Vinogradov, MD · University of Minnesota Department of Psychiatry and Behavioral Sciences

• Caroline Demro, Ph.D. · University of Minnesota Department of Psychiatry and Behavioral Sciences

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-11

Primary Completion

2030-04-30

Completion

2030-04-30

FDA Drug

Yes