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Prednisone for Adults with Immune-Mediated Autism Spectrum Disorder

This study is testing prednisone, a medication, in adults with autism spectrum disorder (ASD) who may have an immune-related subtype. Researchers want to see if prednisone can help with the main features and related symptoms of ASD, and if it is safe to use. You would receive either prednisone or a placebo (an inactive capsule that looks the same). The main goal is to compare how much improvement people experience in their overall condition between the prednisone and placebo groups after 10 weeks. The study is currently unclear on its recruitment status and plans to enroll 32 adult men, aged 18 to 50, who have been diagnosed with ASD.

Study design
This is a randomized, double-blind, placebo-controlled study with two groups, aiming to enroll 32 participants. Participants will be randomly assigned to receive either prednisone or a placebo.
What's involved
You would have up to 5 in-person visits over 20 weeks, including screening, and 8 remote visits. Blood and urine samples will be collected at certain visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a post-discontinuation follow-up visit at Week 20, after the 10-week treatment period.

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NCT06934915

Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder

Recruiting
EARLY_PHASE1Ages 18–50InterventionalTreatment
Christopher John McDougle, M.D.
~32 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:PrednisonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean difference in Clinical Global Impressions-Improvement (CGI-I) ratings between the prednisone and placebo groups at Visit 9
Measured over Baseline to Week 10

Conditions

Autism Spectrum Disorder
Autism Spectrum Disorders
Autistic Disorder
Autism

Explore related trials

Autism Spectrum DisorderAutoimmune DiseaseAntinuclear AntibodyC-Reactive Protein

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Christopher J McDougle, M.D. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Olivia M DeMichaelis
[email protected]
781-860-1711
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A diagnosed comorbid autoimmune disease (e.g., Crohn's disease, Graves' disease, Hashimoto's disease, psoriasis, rheumatoid arthritis, ulcerative colitis, type 1 diabetes mellitus, etc.).
Current biomarker evidence of critical indicators of inflammation/autoimmunity, such as elevated levels of C-reactive protein (CRP) or abnormal value of antinuclear antibodies (ANA).
A significant family history of autoimmunity, defined as having ≥ 1 first-degree relative or ≥ 2 second-degree relatives with autoimmune diseases. The Principal Investigator (PI) will make the final determination on this criterion. 7. Any concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have been stable for at least 4 weeks prior to the screening visit and the participant/study partner intend to maintain a stable regimen throughout the trial. 8. Participant can tolerate swallowing large capsules. 9. Participant is willing and able, in the investigator's opinion, to comply with all study procedures.

What this trial measures

  • Mean difference in Clinical Global Impressions-Improvement (CGI-I) ratings between the prednisone and placebo groups at Visit 9Baseline to Week 10

    Mean difference in CGI-I ratings between the prednisone and placebo groups at Visit 9 (efficacy). The CGI-I is a single-item measure of global symptomatic improvement compared to baseline. Improvement is rated on a 7-point scale, ranging from 1 ("Very much improved") to 7 ("Very much worse"). A global domain score of 1 ("Very much improved") or 2 ("Much improved") on the CGI-I scale will constitute a positive treatment response.