The purpose of this study is to evaluate whether prednisone, an anti-inflammatory medication, affects the core features and associated symptoms of autism spectrum disorder (ASD) in autistic adult males compared with placebo. The study will also assess the safety and tolerability of prednisone in this population. By conducting this study, we hope to better understand the potential role of inflammation in ASD and whether targeting immune-related mechanisms may benefit some autistic adults. Participants will complete screening procedures, including a review of medical and psychiatric history, a physical examination, laboratory testing, an electrocardiogram (ECG), and behavioral assessments. Eligible participants will be randomly assigned to receive either prednisone or placebo. Throughout the study, participants and their study partners will complete questionnaires and behavioral assessments, track study medication use and potential side effects, and attend both in-person and remote study visits. Participants will be enrolled in the study for approximately 20 weeks, including screening and baseline visits, 16 weeks of treatment, and a 4-week follow-up period. Five visits will take place in person at the Lurie Center for Autism, and eight visits will be conducted remotely. In-person visits will last approximately 1.5 to 4.5 hours, while remote visits will last approximately 30 minutes.
To participate in the study, individuals must be 18–50 years old, have been assigned male at birth, and have a diagnosis of ASD with moderate to high support needs. Participants must also have a parent or caregiver who is able to participate as their study partner throughout the study.
08/01/2026 - 01/01/2028
Northeast USA (ME, MA, NH, VT, RI, PA, MD, CT, NY, NJ )
MGH Lurie Center for Autism