About 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
Eligibility criteria
Qualifiers
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
Disqualifiers
Major neurological disorder
History of a clinically significant head injury with or without prolonged unconsciousness
Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating
Renal impairment, injury, or disease
Trial design
Treatments tested in this trial
- Modafinil
- D-serine solution
- Placebo
Treatment groups
6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
University of Minnesota
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator