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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Gagan Joshi
Study ID
NCT06853665
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Adderall XR (mixed salts amphetamine) — DRUG
    Capsule
  • Placebo — DRUG
    Capsule

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2030
Completion
Feb 1, 2030

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mixed Amphetamine Salts (MAS) (also known as Adderall XR)
    Participants in the MAS arm will receive MAS in capsule form daily for 4 weeks . Participants will undergo neuroimaging before and after the 4-week treatment phase.
  • Placebo Comparator: Placebo
    Participants in the placebo arm will receive placebo (no active ingredients) in capsule for daily for 4 weeks. Participants will undergo neuroimaging before and after the 4-week treatment phase.
  • No Intervention: Control Group
    Typically-developing controls will undergo neuroimaging twice (4 weeks apart) and will receive no intervention during the 4-week window.

Primary Outcome Measure

Change in the clinician-rated ADHD-Rating Scale (ADHD-RS) [ Time Frame: Baseline to Week 4 (study endpoint) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Meredith O'Connor, BS
[email protected]
617-724-7301
Gagan Joshi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Massachusetts General Hospital· Boston, MA

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