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
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
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
Crossover
Modafinil
DrugSingle dose of modafinil capsule, 200 mg. Participants will also receive an oral placebo solution to maintain the blind.
D-serine solution
DrugSingle dose of oral solution of d-serine, 100 mg/kg. Participants will also receive a placebo capsule to maintain the blind.
Placebo
DrugSingle dose of oral placebo, in both capsule and oral solution
6
Treatment groupsSee each treatment group below.
Test My Brain - Digit Symbol Coding
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Digit Symbol Coding
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Digit Symbol Coding
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Test My Brain - Digit Symbol Coding
A computerized cognitive assessment measuring processing speed. Z scores range from -5 to 5, with a higher score indicating increased cognitive functioning.
Brief Psychiatric Rating Scale (BPRS) - Global Score
Clinician-administered rating scale to assess psychiatric symptoms such as depression, anxiety, hallucinations, and unusual behavior. Scores on individual items range from 1 (not present) to 7 (extremely severe); global scores range from 24 to 168
Brief Psychiatric Rating Scale (BPRS) - Global Score
Clinician-administered rating scale to assess psychiatric symptoms such as depression, anxiety, hallucinations, and unusual behavior. Scores on individual items range from 1 (not present) to 7 (extremely severe); global scores range from 24 to 168
Brief Psychiatric Rating Scale (BPRS) - Global Score
Clinician-administered rating scale to assess psychiatric symptoms such as depression, anxiety, hallucinations, and unusual behavior. Scores on individual items range from 1 (not present) to 7 (extremely severe); global scores range from 24 to 168
Brief Psychiatric Rating Scale (BPRS) - Global Score
Clinician-administered rating scale to assess psychiatric symptoms such as depression, anxiety, hallucinations, and unusual behavior. Scores on individual items range from 1 (not present) to 7 (extremely severe); global scores range from 24 to 168
Abbreviated Quality of Life Scale (aQLS) - Global Score
Clinician-administered rating scale to assess functioning in schizophrenia. Individual items range from 0 (virtually absent) to 6 (Little or no deficit); global scores range from 0 to 54.
Abbreviated Quality of Life Scale (aQLS) - Global Score
Clinician-administered rating scale to assess functioning in schizophrenia. Individual items range from 0 (virtually absent) to 6 (Little or no deficit); global scores range from 0 to 54.
Abbreviated Quality of Life Scale (aQLS) - Global Score
Clinician-administered rating scale to assess functioning in schizophrenia. Individual items range from 0 (virtually absent) to 6 (Little or no deficit); global scores range from 0 to 54.
Global Functioning - Social Scale (GFS)
Clinician-administered rating scale to assess social functioning. Scores range from 1 (extreme social isolation) to 10 (Superior social/interpersonal functioning)
Click on the lead sponsor to view all of their trials.
University of Minnesota
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
