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

NCT06853665 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025-P-000007
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Attention Deficit Hyperactivity Disorder (ADHD); Autism; Autism Spectrum Disorder

Keywords

ADHD; Attention; Autism; Treatment; Pharmaco-imaging; Imaging; MRI; Drug Study

Outcome Measures

Primary Outcomes (2)

• Change in the clinician-rated ADHD-Rating Scale (ADHD-RS)

  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.

  Baseline to Week 4 (study endpoint)

• Treatment Responder

  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.

  Week 4 (study endpoint)

Secondary Outcomes (2)

• Pre and post treatment changes in ASD core symptoms on Social Responsiveness Scale 2 (SRS-2)

  Baseline to Week 4 (study endpoint)

• Pre and post treatment changes in brain functioning

  Baseline to Week 4 (study endpoint)

Study Arms (3)

Mixed Amphetamine Salts (MAS) (also known as Adderall XR)

EXPERIMENTAL

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.

Drug: Adderall XR (mixed salts amphetamine)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Control Group

NO INTERVENTION

Typically-developing controls will undergo neuroimaging twice (4 weeks apart) and will receive no intervention during the 4-week window.

Interventions

Placebo DRUG

Capsule

Placebo

Adderall XR (mixed salts amphetamine) DRUG

Capsule

Mixed Amphetamine Salts (MAS) (also known as Adderall XR)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gagan Joshi: lead
• Massachusetts Institute of Technology (MIT): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autistic Disorder; Autism Spectrum Disorder

Interventions

SLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Gagan Joshi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith O'Connor, BS

CONTACT

617-724-7301; mghteamstudy@mgb.org

Maria Iorini, BS

CONTACT

617-643-6617; mghteamstudy@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)