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Cognitive Strategies in Early Psychosis 2

Study acronym: COSTEP 2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 21, 2026 to Jul 17, 2026
    v9
  2. Minor Start date: Jul 7, 2026 to Jul 21, 2026v8
  3. Notable Start date: May 11, 2026 to Jul 7, 2026v7
  4. Minor Start date: Apr 13, 2026 to May 11, 2026v6
  5. Minor Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Start date: Mar 15, 2026 to Apr 13, 2026v4
  2. Notable Start date: Feb 1, 2026 to Mar 15, 2026v3
  3. Notable Start date: Dec 1, 2025 to Feb 1, 2026v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07263022
Lead Sponsor University of Minnesota
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Psychosis, Schizophrenia Disorder, Schizoaffective Disorder, Major Depressive Disorder With Psychotic Features, Bipolar Disorder With Psychotic Features, Psychosis NOS, Schizophreniform Disorder, Psychotic Disorder +1 more
Related terms Mental Disorders, Psychotic Disorders, Schizophrenia
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov