Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth With Autism Spectrum Disorder

The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine (NCT06853665) is a Phase 4 interventional studying Attention Deficit Hyperactivity Disorder (ADHD) and Autism, sponsored by Gagan Joshi. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 196 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Attention Deficit Hyperactivity Disorder (ADHD) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 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). - Participants with disruptive behavior disorders, mood and anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria. - 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 willing to sign a consent form. Participants must sign an IRB-approved willing to sign a consent form 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) Typically Developing Control Participants - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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 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). * Participants with disruptive behavior disorders, mood and anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria. * 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) Typically Developing Control Participants * 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) Exclusion Criteria (all participants except where noted): * 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.

Treatments Being Tested

DRUG

Adderall XR (mixed salts amphetamine)

Capsule

DRUG

Placebo

Capsule

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Massachusetts General Hospital
Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06853665), the sponsor (Gagan Joshi), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06853665 clinical trial studying?

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 c… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06853665?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06853665?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06853665. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06853665. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.