Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication for ADHD

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists.

Official registry: https://clinicaltrials.gov/study/NCT05916339 · Daniel Coury · enrollment listed as 500

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, or Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.. The registry lists allocation as randomized. This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism.

They plan to enroll about 500 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder

Interventions: Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.

Primary outcome (registry wording): The Vanderbilt Parent Rating Scale

Who it is for (from inclusion criteria)

  • Ages 4 Years to 17 Years
  • Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements
  • Participant must be between 4 and 17 years of age (inclusive) at time of enrollment
  • Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.)
  • Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid)
  • Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence)
  • Participant must have a consistent reporter (e.g., parent) who spends regular time with the child
  • Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \> 4 weeks prior to consent with no plans for a dose change during the study

Public study contact (from the registry)

Amanda James, BS

(614) 722-4006

Amanda.James@nationwidechildrens.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

13 listed

+ 2 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05916339 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05916339?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05916339?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary