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

Part of paid clinical trials in Lexington, Massachusetts.

Sponsor
Christopher John McDougle, M.D.
Study ID
NCT06934915
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    Starting dose: 5 mg daily. Maximum dose: 60 mg daily. Dosage forms: 5 mg, 10 mg, and 20 mg capsules.
  • Placebo — DRUG
    Capsules identical in size and appearance to those containing prednisone. Placebo capsules contain inactive ingredients.

Study Details

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.

Key Dates

Start date
Nov 30, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prednisone
    Eligible participants will receive prednisone for up to 16 weeks. The treatment period consists of 3 structured phases: Dose Escalation (Weeks 1-5), Optimal Dose Maintenance (Weeks 6-10), and Gradual Dose Reduction (Weeks 11-16).
  • Placebo Comparator: Placebo
    Eligible participants will receive a matching placebo for up to 16 weeks. The treatment period consists of 3 structured phases: Dose Escalation (Weeks 1-5), Optimal Dose Maintenance (Weeks 6-10), and Gradual Dose Reduction (Weeks 11-16).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGH Lurie Center for AutismLexingtonMassachusetts02421
Olivia DeMichaelis
[email protected]
781-860-1711
Colleen G Buckless
[email protected]
781-860-1711
Christopher J McDougle, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
MGH Lurie Center for Autism· Lexington, MA

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