Prednisone for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn how prednisone affects adults with autism spectrum disorder (ASD). It will also learn about the safety of prednisone. The main questions it aims to answer are:* How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD?* Is prednisone safe for autistic adults without causing too many side effects?* Does this study warrant larger trials studying anti-inflammatory drugs in this subject population?Researchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males.Participants will:* Visit the clinic 2 times for a screening and baseline visit.* Take prednisone or a placebo every day for 16 weeks.* Visit the clinic 2 times for checkups, tests, questionnaires, and dose changes, and 1 time for a follow-up visit 4 weeks after stopping the study drug.* Provide blood and urine samples for testing up to 4 times.* Complete 8 remote calls every 1-2 weeks for checkups and dose changes.* Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.
Do I need to stop my current medications to join the trial?
The trial requires that any medications or treatments for ASD-related symptoms have been stable for at least 4 weeks before the screening and remain stable throughout the trial. So, you won't need to stop your current medications, but you should not change them during the study.
How does the drug prednisone differ from other treatments for autism?
Prednisone is a steroid that works by reducing inflammation and suppressing the immune system, which is different from most autism treatments that focus on behavioral therapy or medications targeting neurotransmitters. Its use in autism is novel as it is traditionally used for conditions like asthma and epilepsy, where it helps manage symptoms by reducing inflammation.12345
What data supports the effectiveness of the drug Prednisone for treating autism?
There is no direct evidence from the provided research articles supporting the effectiveness of Prednisone for treating autism. However, Prednisone is known to improve recovery speed in conditions like multiple sclerosis relapses and has been used in asthma treatment, suggesting it may have some impact on inflammation-related conditions.26789
Who Is on the Research Team?
Christopher J McDougle, M.D.
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adult males with autism spectrum disorder (ASD) who may have an immune-related subtype. Participants will be required to visit the clinic multiple times, take daily medication, provide blood and urine samples, participate in remote calls, and keep a diary of their medication intake and any symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive prednisone or placebo for 16 weeks, including dose escalation, maintenance, and reduction phases
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prednisone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Christopher John McDougle, M.D.
Lead Sponsor