Attention Deficit Hyperactivity Disorder (ADHD)Phase 4NCT06853665
The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
A Phase 4 study testing Adderall XR (mixed salts amphetamine) in people with Attention Deficit Hyperactivity Disorder (ADHD) and Autism, run by Gagan Joshi at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), Autism, Autism Spectrum Disorder
- What is being tested?
- Adderall XR (mixed salts amphetamine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 1 Feb 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Meredith O'Connor, BS, 617-724-7301, mghteamstudy@mgb.org
Gagan Joshi, MD
About this study
Official title: A Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth With Autism Spectrum Disorder
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.
- Being tested
- Adderall XR (mixed salts amphetamine), Placebo
- Keywords
- ADHD, Attention, Autism, Treatment, Pharmaco-imaging, Imaging, MRI, Drug Study
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adderall XR (mixed salts amphetamine)Drug
Capsule
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4 (study endpoint)
Secondary outcomes (2)
Pre and post treatment changes in ASD core symptoms on Social Responsiveness Scale 2 (SRS-2)
Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity. The outcome reported reflects the change from baseline in SRS Total raw score and negative scores represent improvement.
Measured: Baseline to Week 4 (study endpoint)
Pre and post treatment changes in brain functioning
The study's primary neuroimaging measures include pre and post-treatment changes in brain functioning using multiple neuroimaging modalities, including resting-state functional MRI to assess connectivity in key networks (default mode, salience, and frontoparietal), task-based fMRI during response inhibition tasks to evaluate activation in inhibitory control regions, and magnetic resonance spectroscopy to analyze neurometabolite concentrations. Multimodal neuroimaging techniques will help identify neural correlates of treatment response by examining changes in large-scale network connectivity patterns (default mode, salience, and frontoparietal), task-related activation in regions previously associated with attention and inhibition (right inferior frontal gyrus, subthalamic nucleus, and anterior cingulate cortex), and alterations in brain neurochemistry (glutamate, GABA, glutathione, N-acetyl aspartate).
Measured: Baseline to Week 4 (study endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Feb 2026
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gagan Joshi
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Sponsor-investigator, Gagan Joshi, Massachusetts General Hospital
- Investigators
- Gagan Joshi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853665
- Sponsor's protocol ID
- 2025-P-000007
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06853665
- Acronym / sponsor ID
- 2025-P-000007
- Keywords
- ADHD, Attention, Autism, Treatment, Pharmaco-imaging, Imaging, MRI, Drug Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Gagan JoshiUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mixed Amphetamine Salts (MAS) (also known as Adderall XR) | Experimental | Drug: Adderall XR (mixed salts amphetamine)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 | Placebo comparator | Drug: PlaceboParticipants 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. |
| Control Group | No intervention | –Typically-developing controls will undergo neuroimaging twice (4 weeks apart) and will receive no intervention during the 4-week window. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (27 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adderall XR (mixed salts amphetamine)Capsule | Drug | Mixed Amphetamine Salts (MAS) (also known as Adderall XR) |
| PlaceboCapsule | Drug | Placebo |
Primary outcome
Change in the clinician-rated ADHD-Rating Scale (ADHD-RS)
Time frame: Baseline to Week 4 (study endpoint)
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.
Treatment Responder
Time frame: Week 4 (study endpoint)
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.
2 secondary outcomes
Pre and post treatment changes in ASD core symptoms on Social Responsiveness Scale 2 (SRS-2)
Time frame: Baseline to Week 4 (study endpoint)
Pre and post treatment changes in brain functioning
Time frame: Baseline to Week 4 (study endpoint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gagan Joshi, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adderall XR (mixed salts amphetamine) in people with Attention Deficit Hyperactivity Disorder (ADHD) and Autism, run by Gagan Joshi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith O'Connor, BS (617-724-7301, mghteamstudy@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinician-rated ADHD-Rating Scale (ADHD-RS) (time frame: Baseline to Week 4 (study endpoint)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.