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New treatment option for ADHD
Official title AWARE: Management of ADHD in Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT05916339
What this study is testing
What is Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication?
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for adhd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 17
You may be able to join if
- Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.
- 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...
- Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).
You likely can't join if
- Participant has taken ADHD medication within the past 7 days.
- Participant is not stable on other medications (\< 4 weeks).
- Any other risk factor that might prevent patient from safely taking the study medications.
- There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as...
See the full eligibility criteria
- Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.
- 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...
- It has been at least 7 days since the participant last took an ADHD medication and the presiding clinician believes this to be a sufficient amount of time.
- Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.
- Participant has taken ADHD medication within the past 7 days.
- Participant is not stable on other medications (\< 4 weeks).
- Any other risk factor that might prevent patient from safely taking the study medications.
- There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- Portland, Maine, United States
- Boston, Massachusetts, United States
- Rochester, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Charlottesville, Virginia, United States
- Edmonton, Canada
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Los Angeles, California, United States; Portland, Maine, United States; Boston, Massachusetts, United States; Rochester, New York, United States; Cincinnati, Ohio, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.