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NCT06853665 · ClinicalTrials.gov registry record · Phase 4
The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
A Phase 4 study of Autism Spectrum Disorder and Autism, sponsored by Gagan Joshi.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 196
- Enrollment target
- 1
- Study location
NCT06853665 is a Phase 4 study of Autism Spectrum Disorder and Autism that is actively recruiting participants, run by Gagan Joshi. The registered enrollment target is 196 participants, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (46% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06853665, a Phase 4 study of Autism Spectrum Disorder and Autism, is actively recruiting participants, sponsored by Gagan Joshi.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 196 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (46% higher). The listed sponsor is Gagan Joshi, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT06853665 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
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).
What interventions are being tested in trial NCT06853665?
The interventions under investigation include: Placebo (DRUG), Adderall XR (mixed salts amphetamine) (DRUG).
Who is sponsoring clinical trial NCT06853665?
This trial is sponsored by Gagan Joshi, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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