Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder (NCT06934915) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder
United States32 participantsStarted 2026-11
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 50 years of age (inclusive) and assigned male at birth.
. Diagnostic Statistical Manual of Mental Disorders (DSM), Fourth Edition, Text Revision (DSM-IV-TR) diagnosed autistic disorder, and DSM, Fifth Edition, Text Revision (DSM-5-TR) diagnosed autism spectrum disorder (ASD), level 2 or 3. A qualified (board-eligible or board-certified) psychiatrist or psychologist, with experience in diagnostic determinations of ASD, will make a final diagnostic determination based on clinical history, clinical observations, medical records, mental status exams, and screening measures.
. A Clinical Global Impression-Severity (CGI-S) rating ≥ 4 ("Moderate") at screening (and baseline).
. A non-verbal IQ in the range of moderate intellectual disability or higher (≥ 35), as measured by the non-verbal Abbreviated IQ (ABIQ) score of the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), or mental age of at least 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the Developmental Profile (DP-4) Parent/Caregiver Interview form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean difference in Clinical Global Impressions-Improvement (CGI-I) ratings between the prednisone and placebo groups at Visit 9
. Participation of a study partner who has consistent contact with the participant and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments.
. Participant reports ≥ 1 of the following:
. 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.
. Participant can tolerate swallowing large capsules.
Exclusion criteria
. DSM-5-TR diagnosed ASD, level 1, or presence of another DSM-IV-TR diagnosed pervasive developmental disorder, such as Asperger's disorder, childhood disintegrative disorder, Rett syndrome, or pervasive developmental disorder not otherwise specified (PDD-NOS). A qualified psychiatrist or psychologist will make a diagnostic determination after reviewing clinical history, clinical observations, medical records, mental status exams, and screening measures.
. A CGI-S rating \< 4 at screening (or baseline).
. A non-verbal IQ in the range of severe or profound intellectual disability (\< 35), as measured by the non-verbal ABIQ score of the SB-5, or mental age below 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the DP-4 Parent/Caregiver Interview form. Individuals testing below 18 months may be enrolled after a case review by the PI and study psychologist, especially if testing scores were likely underestimated due to uncooperative behavior.
. Previous documentation of a prolonged electroencephalogram (EEG) suggestive of Landau-Kleffner syndrome or continuous spike and wave during sleep (CSWS) syndrome.
. Presence of a defined genetic disorder, such as Angelman syndrome, Fragile X syndrome, Noonan syndrome, Tuberous sclerosis, Williams syndrome, or any documented chromosomal or genetic abnormality with proven clinical significance in the etiology of ASD.
. Documented significant pre- or post-natal central nervous system insult, such as an in-utero cerebral vascular accident, that is believed to have significantly contributed to the development of the individual's ASD.
. Mitochondrial disorder verified by skin and/or muscle biopsy.
. History of bipolar disorder or psychotic disorder, including major depressive disorder with psychotic features, schizoaffective disorder, or schizophrenia. History of a significant and interfering comorbid major psychiatric disorder, including obsessive-compulsive disorder, post-traumatic stress disorder, or substance use disorder requiring \> 1 psychiatric hospitalization for treatment of specific comorbid psychiatric disorders above and beyond target symptoms associated with ASD, such as aggression, irritability, self-injury, property destruction, mood swings, or severe tantrums. Minor psychiatric disorders, such as adjustment disorder, attention-deficit hyperactivity disorder, generalized anxiety disorder, major depressive disorder, persistent depressive disorder, or social anxiety disorder, may not exclude participation. The PI will make the final determination on this exclusion criterion.