Actively Recruiting
The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
Led by Gagan Joshi · Updated on 2026-03-06
196
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
G
Gagan Joshi
Lead Sponsor
M
Massachusetts Institute of Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators are conducting a 10-week brain imaging and medication study. They are doing the research to study the response of Attention-Deficit/ Hyperactivity Disorder (ADHD) in youth with Autism Spectrum Disorder (ASD) on extended-release formulation of mixed amphetamine salts (MAS) (also know as Adderall XR). The investigators also want to find out if taking MAS has any effect on the brains of children and adolescents with ADHD and ASD. This study will help researchers better understand how the use of MAS to treat ADHD effects children and adolescents with ASD. The investigators will compare MAS to a placebo. The placebo will look exactly like the MAS capsules but will contain no MAS. During this study, participants may get a placebo instead of MAS. Placebos are used in research studies to see if the study results are due to the study drug or due to other reasons. Participants with ASD and ADHD will complete 4-weeks of treatment with the study medication or placebo. They will complete bi-weekly study visits virtually via a telemedicine platform with the study doctor and complete questionnaires. On alternating weeks, they will meet with a Massachusetts General Hospital (MGH) study team member to discuss medication adherence and potential side effects. Participants will have the option to attend all study visits in-person if participants prefer. They will also complete baseline and endpoint Magnetic Resonance (MR) scan visits at Massachusetts Institute of Technology (MIT). During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory. Participants without ADHD or ASD will complete eligibility screening with MGH. If eligible, they will be invited to baseline and endpoint MR scan visits at MIT. During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.
CONDITIONS
Official Title
The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with Autism Spectrum Disorder (ASD) and Attention Deficit/Hyperactivity Disorder (ADHD)
- Male or female participants between 8 and 18 years of age (inclusive)
- Participant must have intact communicative language as clinically determined
- Meet DSM-5-TR diagnoses of ADHD and ASD confirmed by clinical interview
- At least moderate current ADHD severity (Clinician-rated ADHD-RS score 28 and ADHD-CGI-S score 4)
- At least moderate current ASD severity (SRS-2 raw score 85 and ASD-CGI-S score 4)
- Participants with disruptive behavior, mood, or anxiety disorders are allowed if they do not meet exclusion criteria
- Must be on a stable regimen of psychotropic treatment
- Must understand study nature, have decision-making capacity, and provide informed consent
- Must be able to communicate and cooperate with study procedures
- Participant weight must be above 5th percentile and below 95th percentile per CDC child BMI categories
- Typically developing control participants age-, sex-, and IQ-matched with ASD participants
- Control participants must have no significant ASD traits (SRS-2 raw score <60)
- Control participants must have no significant ADHD symptoms (parent-rated ADHD-RS score <18)
- Control participants must have no significant psychopathology (CBCL subdomain T-scores <60)
- Control participant weight must be above 5th percentile and below 95th percentile per CDC child BMI categories
You will not qualify if you...
- Impaired intellectual capacity as determined by history or clinical evaluation (ASD participants only)
- Unable to communicate due to severe language delay or lack of spoken language
- Poor command of English or requiring an interpreter
- Unable to swallow pills (ASD participants only)
- Medical conditions or treatments that risk safety or study validity
- Pregnant or nursing females or positive pregnancy test
- Uncorrected thyroid disorders
- History of non-febrile seizures within last month without clear cause
- Diagnosis of glaucoma (ASD participants only)
- History of renal or hepatic impairment
- Serious systemic illness
- Personal or family history of early cardiac disease or death (ASD only)
- Known medical risk factors placing participant at risk for adverse effects (ASD only)
- Unstable medical condition requiring clinical attention
- Clinically unstable psychiatric conditions or serious safety risk within past 30 days
- Significant symptom severity of major psychiatric disorders in past 30 days
- Active anorexia or bulimia nervosa
- History of substance use (except nicotine, recreational THC, or caffeine) in past 3 months
- Started new psychosocial intervention within 4 weeks before randomization
- Psychotropic medication dose not stable for at least 4 weeks prior to baseline
- Use of MAOI within 2 weeks prior to study medication
- Use of stimulant medication (ASD participants on stable non-stimulant ADHD meds allowed)
- History of non-response or poor tolerability to amphetamine salts (ASD only)
- History of allergic reaction to amphetamine or dextroamphetamine (ASD only)
- Investigator or immediate family member involvement
- Contraindications to MRI scanning (controls with contraindications not eligible)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Meredith O'Connor, BS
CONTACT
M
Maria Iorini, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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