Study of Modafinil and D-serine Effects on Brain Function and Decision Making in Adults 18 to 35 with Early Psychosis Spectrum Disorders

What this Trial Is About

Researchers are studying decision making in people with psychosis spectrum disorders, such as schizophrenia, with symptoms starting within the last five years. They aim to understand how single doses of two study agents, modafinil and d-serine, affect decision making and brain activity. This study is a Phase 3 clinical trial designed to improve knowledge about psychosis and includes participants aged 18 to 35. Participants will take single doses of modafinil 200 mg, d-serine 100 mgkg, and a placebo twice each during six functional Magnetic Resonance Imaging fMRI appointments spaced about a month apart. Each fMRI visit includes brain scans, computer-based brain games that assess decision making, and safety monitoring. The study uses a randomized, triple-blinded crossover design, so each participant receives all three agents in varied sequences. Participants will complete ten total appointments, including an initial intake, six fMRI sessions, three clinical interviews, and several brief check-ins via phone or Zoom. Assessments include interviews on mental health and quality of life, blood draws, urine and breath tests, vision and vital sign checks, and repeated cognitive testing using brain games. Outcome measures focus on changes in brain game performance and brain activity, along with psychiatric symptom ratings, tracked throughout the study lasting several months.

Cognitive Strategies in Early Psychosis 2