Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
NCT06853665 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Placebo
- DRUG Adderall XR (mixed salts amphetamine)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2030-02-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06853665
The ClinicalTrials.gov registry entry for NCT06853665 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gagan Joshi, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06853665 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06853665 about?
NCT06853665 is a clinical study titled "The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine". 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 kno...
What is the current status of trial NCT06853665?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 196 participants. The study started on 2026-02-01. Estimated completion is 2030-02-01.
What conditions does trial NCT06853665 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism, Attention Deficit Hyperactivity Disorder (ADHD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06853665?
The interventions under investigation include: Placebo (DRUG), Adderall XR (mixed salts amphetamine) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06853665?
This trial is sponsored by Gagan Joshi, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06853665 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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