32 Participants Needed

Prednisone for Autism

AC
CB
Overseen ByColleen Buckless
Age: 18 - 65
Sex: Male
Trial Phase: Phase < 1
Sponsor: Christopher John McDougle, M.D.

Trial Summary

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.

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.12345

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.26789

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.

Research Team

CJ

Christopher J McDougle, M.D.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

Clinical Global Impression-Severity (CGI-S) rating ≥ 4 at screening
Diagnosed with autistic disorder or autism spectrum disorder (ASD) level 2 or 3 by a qualified psychiatrist or psychologist
Non-verbal IQ in the range of moderate intellectual disability or higher (≥ 35)
See 6 more

Exclusion Criteria

Non-verbal IQ in the range of severe or profound intellectual disability (< 35)
Concomitant medications not stable for at least 4 weeks prior to screening
Diagnosed with ASD level 1 or another pervasive developmental disorder
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
2 visits (in-person)

Treatment

Participants receive prednisone or placebo for 16 weeks, including dose escalation, maintenance, and reduction phases

16 weeks
3 visits (in-person), 8 remote calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Prednisone
Trial Overview The study tests prednisone's effects on ASD core features compared to a placebo over 16 weeks. It aims to determine if prednisone is safe and effective enough to consider larger trials on anti-inflammatory drugs for autistic adults.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrednisoneExperimental Treatment1 Intervention
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).
Group II: PlaceboPlacebo Group1 Intervention
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Christopher John McDougle, M.D.

Lead Sponsor

Findings from Research

In a study of 1161 children aged 4 to 17 hospitalized for asthma exacerbations, dexamethasone was compared to prednisone, showing a slightly higher return utilization rate of 3.9% versus 2.2%, respectively.
However, the analysis indicated that the choice of steroid (dexamethasone vs. prednisone) did not significantly impact the likelihood of unplanned readmissions or emergency department visits within 30 days after discharge.
Dexamethasone Versus Prednisone in Children Hospitalized With Asthma Exacerbation.Hoefgen, ER., Huang, B., Schuler, CL., et al.[2022]

References

Lack of efficacy of single-dose prednisolone in moderately severe asthma. [2013]
Prednisone dose limitation of growth hormone treatment of steroid-induced growth failure. [2019]
High dose oral steroids commonly used to treat relapses in Canadian MS clinics. [2019]
Relationship between alternate-day corticosteroid therapy and behavioral abnormalities. [2016]
Prednisolone and salbutamol in the hospital treatment of acute asthma. [2019]
A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis. [2019]
High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. [2022]
Prednisone therapy in pediatric epilepsy. [2019]
Dexamethasone Versus Prednisone in Children Hospitalized With Asthma Exacerbation. [2022]
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