Cognitive Strategies in Early Psychosis 2

Sponsor
University of Minnesota
Study ID
NCT07263022
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Modafinil — DRUG
    Single dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind.
  • D-serine solution — DRUG
    Single dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind.
  • Placebo — DRUG
    Single dose of oral placebo, in both capsule and oral solution

Study Details

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 Dates

First listed
Dec 4, 2025
Start date
Jul 21, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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)

Primary Outcome Measure

Test My Brain - Digit Symbol Coding [ Time Frame: Baseline ]

Central Contacts

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