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Evaluating Treatment of ADHD in Children With Down Syndrome

Study acronym: TEAM-DS
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 10, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 30, 2025 → Aug 31, 2026
See other at-risk trials from Children's Hospital Medical Center, Cincinnati

Record History

  1. Primary and study completion pushed from Sep 30, 2025 to Aug 31, 2026 Enrollment closed, study ongoing · Site details revised at 4 of 4 sitesv12 Show 2 more changesShow less
    • Enrollment closed, study ongoing
    • Site details revised at 4 of 4 sites
  2. Study sites: 2 to 4 Study description revised · Collaborators: 1 to 3v11 Show 2 more changesShow less
    • Study description revised
    • Collaborators: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Sep 30, 2019 to Oct 2, 2020 Primary and study completion dates: Sep 2025 to Sep 30, 2025v10 Show 1 more changeShow less
    • Primary and study completion dates: Sep 2025 to Sep 30, 2025
  4. Phase: Phase 1/2 to Phase 4 Enrollment target: 30 to 100 · Primary endpoints: 4 to 2 · Primary and study completion dates: Aug 2025 to Sep 2025 · 5 morev9 Show 8 more changesShow less
    • Enrollment target: 30 to 100
    • Primary endpoints: 4 to 2
    • Primary and study completion dates: Aug 2025 to Sep 2025
    • Start date: Oct 2, 2020 to Sep 30, 2019
    • Interventions: Placebos (Drug), Quillivant XR (Drug) to Placebo (Drug), Quillivant XR (Drug)
    • Eligibility criteria expanded, about 96 words
    • Secondary endpoints: 4 to 9
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Jan 2022 to Aug 2025v8
Show 6 earlier versionsHide 6 earlier versions
  1. Site contacts updated at 1 of 2 sitesv7
  2. Eligibility criteria expanded, about 176 words Site contacts updated at 1 of 2 sitesv6 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2020 to Oct 2, 2020 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2020 to Oct 2, 2020
    • Site details revised at 2 of 2 sites
  5. Start date: Jan 2020 to Aug 2020v3
  6. Primary endpoints: 2 to 4 Secondary endpoints revised (4)v2 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD. The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.
Trial Details
NCT Number NCT04219280
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: University of California, Davis, University of Pittsburgh Medical Center, Boston Children's Hospital, Boston, MA, USA
Conditions Down Syndrome, ADHD
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov