Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome

Who is this study for? Child patients with Attention Deficit Hyperactivity Disorder
What treatments are being studied? Quillivant
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: t
View:

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Male or female, between the ages of 6.00-17.99 years at the time of consent.

• Able to take oral (liquid) medication.

• English is primary language.

• Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS

• Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)

Locations
United States
California
University of California Davis MIND Institute
COMPLETED
Sacramento
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Emily K Hoffman, MEd
Emily.Hoffman1@cchmc.org
513-803-3641
Time Frame
Start Date: 2020-10-02
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 100
Treatments
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.
Authors
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: Boston Children's Hospital, Boston, MA, USA, University of California, Davis, University of Pittsburgh Medical Center

This content was sourced from clinicaltrials.gov