D-serine + Modafinil for Psychosis
(COSTEP 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Sophia Vinogradov, MD
Principal Investigator
University of Minnesota Department of Psychiatry and Behavioral Sciences
Caroline Demro, Ph.D.
Principal Investigator
University of Minnesota Department of Psychiatry and Behavioral Sciences
Are You a Good Fit for This Trial?
This trial is for adults aged 18-35 who have been diagnosed with a psychosis spectrum disorder (like schizophrenia or bipolar disorder with psychosis) that started within the last five years. Participants must speak English, have an IQ of at least 70, and be on stable medication doses.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- D-serine
- Modafinil
Trial Overview
The study tests how single doses of modafinil, d-serine, or a placebo affect thinking and decision making in people with early psychosis. Each participant tries all three agents during separate visits while doing brain scans and computer-based brain games.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
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)
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)
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)
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)
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)
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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
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