Evaluating Treatment of ADHD in Children with Down Syndrome

Conditions

• ADHD
• Down Syndrome

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Accepted

Interventions

• Quillivant XR — DRUG
  Long-lasting liquid solution of Quillivant XR.
• Placebo — DRUG
  Liquid solution to mimic the color and taste of Quillivant XR.

Study Details

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.

Key Dates

Start date

Oct 2, 2020

Status verified

Jan 2025

Primary completion

Sep 30, 2025

Completion

Sep 30, 2025

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Quillivant XR
  Once-daily, long-lasting MPH solution with the following dosing schedules: 7.5mg/15mg/22.5mg/30mg for children 20-25kg 10mg/20mg/30mg/40mg for children 26-30kg 10mg/22mg/34mg/46mg for children \> 30 mg
• Placebo Comparator: Placebo
  Liquid-based suspension to match the color and banana-flavor of Quillivant XR.

Primary Outcome Measure

Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ] [ Time Frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30 ]

Central Contacts

• Emily K Hoffman, MEd
  513-803-3641
  [email protected]

Locations (4)

Find similar trials in Sacramento, CA

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