Trial · NCT06853665
The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
NCT06853665, Phase 4, Recruiting, Gagan Joshi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine. Trials, record NCT06853665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06853665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine
- NCT number
- NCT06853665
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 196 participants, estimated
- Lead sponsor
- Gagan Joshi
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD), Autism, Autism Spectrum Disorder
- Interventions
- Adderall XR (mixed salts amphetamine), Placebo
- First posted
- 2025-03-03
- Last updated
- 2026-03-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the clinician-rated ADHD-Rating Scale (ADHD-RS) | 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. |
| Primary | Treatment Responder | 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. |
| Secondary | Pre and post treatment changes in ASD core symptoms on Social Responsiveness Scale 2 (SRS-2) | Baseline to Week 4 (study endpoint) | 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. |
| Secondary | Pre and post treatment changes in brain functioning | Baseline to Week 4 (study endpoint) | 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). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06853665
GET https://conductscience.org/api/trials/v1/NCT06853665/registered