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The TEAM Study: Adderall XR for ADHD in Youth with Autism

This study, called The TEAM Study, is looking at how Adderall XR (mixed salts amphetamine) affects Attention-Deficit/Hyperactivity Disorder (ADHD) in young people who also have Autism Spectrum Disorder (ASD). Researchers want to see if Adderall XR helps with ADHD symptoms and if it changes the brain in children and adolescents with both conditions. You would receive either Adderall XR or a placebo (a capsule with no medicine) for 10 weeks. The study will measure changes in ADHD symptoms using a clinician-rated scale. This study is currently recruiting 196 participants aged 8 to 18 years old who have both ADHD and ASD and intact communication skills.

Study design
This is an interventional study comparing Adderall XR to a placebo in approximately 196 participants. The study is 10 weeks long.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Week 4 (study endpoint).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06853665

The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine

Recruiting
PHASE4Ages 8–18InterventionalTreatment
Gagan Joshi
~196 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:Adderall XR (mixed salts amphetamine)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the clinician-rated ADHD-Rating Scale (ADHD-RS)
Measured over Baseline to Week 4 (study endpoint)
+1 more outcome measured

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)
Autism
Autism Spectrum Disorder

Explore related trials

Attention Deficit Hyperactivity DisorderAutism Spectrum Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Gagan Joshi, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Meredith O'Connor, BS
[email protected]
617-724-7301
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female participants between 8 and 18 years of age (inclusive).
Participant intact communicative language, as clinically determined.
Meet DSM-5-TR diagnoses of ADHD and ASD as established by clinical diagnostic interview.
At least moderate current ADHD symptoms severity (Clinician-rated ADHD-RS score ≥28 and ADHD-CGI-S of ≥4)
At least moderate current ASD symptoms severity (SRS-2 raw score ≥85 and ASD-CGI-S of ≥4).

Exclusion

Participant must be on a stable regimen of psychotropic treatment.
Participants must understand the nature of the study. Participants must be deemed not to have impaired decision-making capacity and must have the capacity to provide direct informed consent. Participants must sign an IRB-approved informed consent form before initiation of any study procedures.
Participants must have a level of understanding sufficient to communicate with the investigator and study coordinator and be willing to cooperate with all tests and examinations required by the protocol.
Participant weight is above the 5th percentile and below the 95th percentile, per CDC child BMI categories (https://www.cdc.gov/obesity/basics/childhood-defining.html)
Age-, sex-, \& IQ-matched with ASD participants.
No significant traits of ASD as screened by SRS-2 (raw score \<60).
No significant ADHD symptoms as screened by parent-rated ADHD-RS (score \<18)
No significant psychopathology as screened on the CBCL (Subdomain T-scores \<60).
Participant weight is above the 5th percentile and below the 95th percentile, per CDC child BMI categories (https://www.cdc.gov/obesity/basics/childhood-defining.html)
Impaired intellectual capacity as determined either by history of intellectual disability or as assessed, in ASD participants only, during the clinical evaluation and determination will be based on intact communicative language, intellectual performance, and ability to take personal care.
Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
Participants with a poor command of the English language and/or require an interpreter.
Participant is unable to swallow pills (ASD participants only)
Participants with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
Pregnant or nursing females or females with a positive Beta-HCG pregnancy test.
Uncorrected hypothyroidism or hyperthyroidism.
History of non-febrile seizures within last 1 month without a clear and resolved etiology.
Diagnosis of glaucoma (ASD participants only)
History of renal or hepatic impairment.
Serious systemic illness
Personal history of cardiac disease or a family history of non-geriatric cardiac disease or death (ASD only)
Participants with known medical risk factors (e.g., known untreated hypertension, arrhythmia, premature family history of sudden death) and active symptoms that, in the investigators' opinion, place them at risk for untoward adverse effects (ASD only)
Participants with an unstable medical condition (that requires clinical attention).
Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days).
Participants currently (within past 30 days) experiencing significant symptom severity of major psychiatric disorders as clinically determined.
Active symptoms of anorexia or bulimia nervosa
History of substance use (except nicotine, recreational use of THC, or caffeine) within past 3 months
Initiation of a new psychosocial intervention within 4 weeks prior to randomization.
Participants treated with a psychotropic medication(s) on a dose that has not been stable for at least 4 weeks prior to study baseline.
Participants receiving treatment with an MAOI within two weeks prior to receiving study medication.
Participants receiving treatment with stimulant class of medication. (ASD participants on a stable treatment of non-stimulant ADHD treatment medications will be included.)
History of non-response of ADHD symptoms to amphetamine salt as defined by being on therapeutic dose for at least 1 week. (ASD only)
Subjects with previous poor response or poor tolerability to mixed amphetamine salts (ASD only)
History of allergic reaction to amphetamine or dextroamphetamine (for ASD participants only)
Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Contraindications to MRI scanning as described in the MIT MRI Screening Checklist. Subjects can choose a security object (e.g., fidget toy, stuffed animal, or blanket) that is MRI-safe and provided by the imaging center, in the scanner to help with possible anxiety they might experience due to the scanning. Typically developing control subjects with contraindications to MRI scanning will not be eligible to participate in the trial.

What this trial measures

  • Change in the clinician-rated ADHD-Rating Scale (ADHD-RS)Baseline to Week 4 (study endpoint)

    Efficacy will be assessed by reduction in ADHD symptoms as measured by change from baseline on the clinician-rated ADHD-Rating Scale (ADHD-RS). The ADHD-RS-V is a physician-rated scale to assess the ADHD symptom severity in participants aged 5 to 17 years old. It is an 18-item rating-scale corresponding to DSM-5 diagnostic symptom criteria. Total scores range from 0-54, where higher scores indicate greater severity. The outcome reported reflects the change from baseline in ADHD-RS score and negative scores represent improvement.

  • Treatment ResponderWeek 4 (study endpoint)

    Responders are defined as ≥30% reduction in clinician-rated ADHD-Rating Scale (ADHD-RS) and clinician-rated Clinical Global Impression-Improvement score for ADHD (ADHD-CGI-I) ≤2 OR ≥25% reduction in parent-rated ADHD-RS and clinician-rated ADHD-CGI-I score ≤2.