Adderall XR for ADHD

Overseen By Meredith O'Connor, BS

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Gagan Joshi

Must be taking: Non-stimulant ADHD treatment

Must not be taking: MAOIs, Stimulants

Disqualifiers: Intellectual disability, Cardiac disease, Seizures, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how Adderall XR, a medication commonly used for ADHD, affects children and teens with Autism Spectrum Disorder (ASD). Researchers will compare Adderall XR to a placebo to determine if the medication changes brain activity and alleviates ADHD symptoms in participants with ASD. The trial suits children and adolescents aged 8-18 who have both ADHD and ASD and experience moderate symptoms. Participants will receive either the medication or a placebo and undergo brain scans and other assessments to track changes. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, offering participants a chance to contribute to valuable insights.

Will I have to stop taking my current medications?

The trial requires that participants stop taking stimulant medications, but those on a stable dose of non-stimulant ADHD medications can continue. If you are on a psychotropic medication, your dose must be stable for at least 4 weeks before starting the study.

What is the safety track record for Adderall XR?

Research has shown that Adderall XR, a medication for ADHD, is usually well-tolerated. Studies have found that taking up to 40 mg of Adderall XR once a day is effective and safe for teenagers with ADHD. Common side effects include trouble sleeping and dry mouth. Importantly, evidence indicates that ADHD medications like Adderall XR do not increase the risk of serious heart problems in young people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for ADHD involve stimulant medications like methylphenidate or amphetamine salts that help increase attention and control impulsive behaviors. Adderall XR, a mixed amphetamine salts formulation, stands out because it provides a long-lasting effect with just one daily dose, thanks to its extended-release technology. This means more consistent symptom control throughout the day, potentially reducing the need for multiple doses. Researchers are excited because this convenience can improve adherence to treatment and enhance the quality of life for individuals with ADHD.

What is the effectiveness track record for Adderall XR in treating ADHD in youth with Autism Spectrum Disorder?

Research has shown that Adderall XR, a type of medication, effectively treats ADHD symptoms. Studies have found a 42% reduction in symptoms such as inattention and hyperactivity. In children, taking Adderall XR once daily led to steady behavioral improvements over two years. This trial will include a treatment arm where participants receive Adderall XR (Mixed Amphetamine Salts) daily for four weeks. This medication is already approved for ADHD, and these findings support its continued effectiveness and safety for this condition. ^{4 6 7 8 9}

Who Is on the Research Team?

Gagan Joshi, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for children and adolescents with both Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD). They will be tested to see how a medication called Adderall XR, which is used for ADHD, affects their brain function. Participants must be able to attend study visits virtually or in person and undergo MRI scans.

Inclusion Criteria

Participants with Autism Spectrum Disorder and Attention Deficit/Hyperactivity Disorder

Must meet DSM-5-TR diagnoses of ADHD and ASD as established by clinical diagnostic interview

Must have at least moderate current ADHD symptoms severity (Clinician-rated ADHD-RS score ≥28 and ADHD-CGI-S of ≥4)

Exclusion Criteria

Participant unable to swallow pills (ASD participants only)

History of substance use (except nicotine, recreational use of THC, or caffeine) within the past 3 months

Participants with poor command of the English language and/or require an interpreter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either mixed amphetamine salts (MAS) or placebo for 4 weeks, with bi-weekly virtual visits and MR scans at baseline and endpoint

4 weeks

2 visits (in-person for MR scans), 2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adderall XR

Trial Overview

The TEAM Study tests the effectiveness of Adderall XR compared to a placebo over 10 weeks. It involves virtual bi-weekly check-ins, questionnaires about behavior changes, adherence discussions, and two MRI scans at MIT to assess brain activity related to attention and decision-making.

How Is the Trial Designed?

Group I: Mixed Amphetamine Salts (MAS) (also known as Adderall XR) Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Gagan Joshi

Lead Sponsor

Trials

1

Recruited

200+

Massachusetts Institute of Technology (MIT)

Collaborator

Trials

2

Recruited

200+

Published Research Related to This Trial

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

Adderall XR is a long-acting psychostimulant approved for treating ADHD in both children and adults, with a 12-hour duration of action and demonstrated superior efficacy compared to the nonstimulant atomoxetine.

The largest effectiveness trial for ADHD therapies confirmed that Adderall XR significantly improves quality of life in children and shows proven safety and efficacy in adults, with potential benefits for treating comorbid conditions like oppositional defiant disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adderall XR: long acting stimulant for single daily dosing. Sallee, FR., Smirnoff, AV.[2019]

SLI381 (Adderall XR) demonstrated significant, dose-related improvements in ADHD symptoms in children aged 6 to 12 years, with consistent efficacy observed throughout the day, as measured by both teachers and parents.

The study, involving 584 children in a randomized, double-blind trial, showed that SLI381 was well-tolerated with a low incidence of adverse events, indicating it is a safe and effective once-daily treatment for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder. Biederman, J., Lopez, FA., Boellner, SW., et al.[2019]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/11483144/

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Drug-specific improvement in ADHD symptoms was highly significant overall (42% decrease on the ADHD Rating Scale, P<.001), and sufficiently robust to be ...

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Efficacy of a Mixed Amphetamine Salts Compound in ...

Drug-specific improvement in ADHD symptoms was highly significant overall (42% decrease on the ADHD Rating Scale, P<.001), and sufficiently robust to be ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0890856709616282

Long-Term Tolerability and Effectiveness of Once-Daily ...

In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months ...

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tandfonline.com

tandfonline.com/doi/full/10.1080/14737175.2024.2321921

A review of amphetamine extended release once-daily ...

Multiple studies showed significant improvement in symptoms of attention deficit hyperactivity disorder with mixed amphetamine salts. Original ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT00712699

Effectiveness of an Extended Release Stimulant ...

This study will evaluate the safety and effectiveness of extended release mixed amphetamine salts in treating preschool children with attention deficit ...

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fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-medications-used-treat-attention

Safety Review Update of Medications used to treat ADHD

Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6513464/

Amphetamines for attention deficit hyperactivity disorder ...

Amphetamines (a type of stimulant) are thought to improve ADHD symptoms, but there are concerns about how safe they are for regular use by patients with ADHD.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0149291806000518

Efficacy and safety of mixed amphetamine salts extended ...

Results of this study suggest that once-daily dosing with MAS XR up to 40 mg was effective and well tolerated for the management of ADHD in these adolescents.

9.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2833773

Safety of Stimulants Across Patient Populations: A Meta- ...

In adults with ADHD, amphetamine-XR trials revealed no changes in the expected safety profile. Common TEAEs included insomnia, dry mouth, and ...