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

NCT06934915 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Prednisone

Starting dose: 5 mg daily. Maximum dose: 60 mg daily. Dosage forms: 5 mg, 10 mg, and 20 mg capsules.

DRUG

Placebo

Capsules identical in size and appearance to those containing prednisone. Placebo capsules contain inactive ingredients.

Sponsors & Collaborators

  • Christopher John McDougle, M.D.

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-07-31
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934915 on ClinicalTrials.gov