Autism Spectrum DisorderEarly Phase 1PREDICTNCT06934915
Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder
A Early Phase 1 study testing Prednisone in people with Autism Spectrum Disorder and Autism Spectrum Disorders, run by Christopher John McDougle, M.D. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Autism Spectrum Disorder, Autism Spectrum Disorders, Autistic Disorder
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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:
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- 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.
- 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.
- Participant is willing and able, in the investigator's opinion, to comply with all study procedures.
- Individuals must satisfy the following criteria to be enrolled as study partners:
- The study partner is fluent in English.
- The study partner is a caregiver or an individual who has consistent contact with the participant, knows the participant well, 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. The PI will make the final determination on this criterion.
Who cannot join
- 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.
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- Mitochondrial disorder verified by skin and/or muscle biopsy.
- History of bipolar disorder, psychotic disorder or schizophrenia.
- History of one or more psychiatric hospitalizations due to symptoms of a major psychiatric disorder (e.g., major depressive disorder, OCD, PTSD, severe anxiety disorders, or substance use disorder). Hospitalization exclusively for irritability or behavioral dysregulation related to ASD, without evidence of a comorbid major psychiatric disorder, is permitted.
- 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 not been stable for at least 4 weeks prior to the screening visit.
- An active bacterial, fungal, helminthic, protozoan, or viral infection that could be exacerbated by a course of prednisone, as determined by the PI.
- Significant medical findings from history, physical examination, or laboratory testing that may be incompatible with prednisone use (e.g., participants with chronic infectious conditions or unstable diabetes mellitus, defined as insulin-dependent or HbA1c >7.0).
- Individuals with a history of seizures being treated with an anticonvulsant may be eligible if seizure-free for at least 6 months and the anticonvulsant dose has been stable for at least 4 weeks prior to the screening visit.
- Use of immunosuppressive agents within the 6 months prior to the screening visit or concurrent use of immunosuppressive agents that, in the judgment of the PI, would interfere with study outcomes or pose unreasonable risk with prednisone administration.
- A known hypersensitivity to prednisone or any other component of the study product.
- The participant is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.
- Individuals may be excluded from enrollment as study partners if either of the following criteria are met:
- The study partner is not fluent in English.
- The study partner is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGH Lurie Center for Autism
Lexington, Massachusetts, 02421
Olivia DeMichaelis, 781-860-1711, MGHPREDICT-ASD@mgb.org
Colleen G Buckless, 781-860-1711, MGHPREDICT-ASD@mgb.org
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups Trial of Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder
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?
Read more
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.
Read the detailed description
- Randomized, double-blind, placebo-controlled, parallel-groups, flexibly dosed trial. Eligible autistic male participants will be randomized 1:1 to receive prednisone or a placebo.
- Participants will attend up to 5 in-person study visits: screening, baseline, Week 5, Week 10, and Week 20 (post-discontinuation follow-up).
- Interim dose adjustments will be determined during 8 scheduled remote visits: Weeks 1-4, Week 7, Week 12, Week 14, and Week 16.
- Blood and urine specimens will be collected for safety and biomarker assessments: screening, Week 5, Week 10, and Week 20.
- Being tested
- Prednisone, Placebo
- Keywords
- Autism Spectrum Disorder, Autistic Disorder, Autism, Autoimmunity, Autoimmune Disorders, Inflammation, Neuroinflammation, Anti-Inflammatory Agents, Corticosteroids, Glucocorticoids, Prednisone
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Autoimmune Diseases, Inflammation, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Starting dose: 5 mg daily. Maximum dose: 60 mg daily. Dosage forms: 5 mg, 10 mg, and 20 mg capsules.
PlaceboDrug
Capsules identical in size and appearance to those containing prednisone. Placebo capsules contain inactive ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | 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). Receives: Drug: Prednisone |
| Placebo | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in Clinical Global Impressions-Improvement (CGI-I) ratings between the prednisone and placebo groups at Visit 9
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.
Measured: Baseline to Week 10
Secondary outcomes (4)
Number of randomized study participants
Number of randomized study participants (feasibility).
Measured: At Baseline
Percent of participants enrolled at Visit 9 (Week 10) and contributing a visit 9 CGI-I rating
Percent of participants enrolled at Visit 9 (Week 10) and contributing a visit 9 CGI-I rating, irrespective of treatment continuation (feasibility).
Measured: Baseline to Week 10
Percent of participants randomized to prednisone experiencing serious adverse events (SAEs) probably or definitely related to medication
Percent of participants randomized to prednisone experiencing serious adverse events (SAEs) probably or definitely related to medication (safety).
Measured: Baseline to Week 20
Percent of participants randomized to prednisone who complete a ten-week course of study drug
Percent of participants randomized to prednisone who complete a ten-week course of study drug (tolerability).
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Aug 2026
- Primary completionJul 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to prednisone or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher John McDougle, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher John McDougle, M.D., Massachusetts General Hospital
- Investigators
- Christopher J McDougle, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934915
- Sponsor's protocol ID
- 2024P003682
- Acronym
- PREDICT
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to externally share IPD at this time, due to concerns regarding participant privacy, the risk of reidentification given the small and vulnerable study population, and limitations in the consent materials and protocol, which do not currently permit external data sharing. Institutional policy requires specific Data Use Agreements for any data sharing activity, and the study is protected by a Certificate of Confidentiality, further restricting disclosure of identifiable information. The research team may consider sharing de-identified data in the future, contingent upon publication of results and implementation of robust governance and approval mechanisms.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups Trial of Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06934915
- Acronym / sponsor ID
- PREDICT / 2024P003682
- Keywords
- Autism Spectrum Disorder, Autistic Disorder, Autism, Autoimmunity, Autoimmune Disorders, Inflammation, Neuroinflammation, Anti-Inflammatory Agents
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Christopher John McDougle, M.D.University, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Randomized, double-blind, placebo-controlled, parallel-groups, flexibly dosed trial. Eligible autistic male participants will be randomized 1:1 to receive prednisone or a placebo.
- Participants will attend up to 5 in-person study visits: screening, baseline, Week 5, Week 10, and Week 20 (post-discontinuation follow-up).
- Interim dose adjustments will be determined during 8 scheduled remote visits: Weeks 1-4, Week 7, Week 12, Week 14, and Week 16.
- Blood and urine specimens will be collected for safety and biomarker assessments: screening, Week 5, Week 10, and Week 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to prednisone or placebo.
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisoneEligible 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 | Placebo comparator | Drug: PlaceboEligible 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneStarting dose: 5 mg daily. Maximum dose: 60 mg daily. Dosage forms: 5 mg, 10 mg, and 20 mg capsules. | Drug | Prednisone |
| PlaceboCapsules identical in size and appearance to those containing prednisone. Placebo capsules contain inactive ingredients. | Drug | Placebo |
Primary outcome
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
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.
4 secondary outcomes
Number of randomized study participants
Time frame: At Baseline
Percent of participants enrolled at Visit 9 (Week 10) and contributing a visit 9 CGI-I rating
Time frame: Baseline to Week 10
Percent of participants randomized to prednisone experiencing serious adverse events (SAEs) probably or definitely related to medication
Time frame: Baseline to Week 20
Percent of participants randomized to prednisone who complete a ten-week course of study drug
Time frame: Baseline to Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to externally share IPD at this time, due to concerns regarding participant privacy, the risk of reidentification given the small and vulnerable study population, and limitations in the consent materials and protocol, which do not currently permit external data sharing. Institutional policy requires specific Data Use Agreements for any data sharing activity, and the study is protected by a Certificate of Confidentiality, further restricting disclosure of identifiable information. The research team may consider sharing de-identified data in the future, contingent upon publication of results and implementation of robust governance and approval mechanisms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher J McDougle, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Prednisone in people with Autism Spectrum Disorder and Autism Spectrum Disorders, run by Christopher John McDougle, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia M DeMichaelis (781-860-1711, MGHPREDICT-ASD@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.