Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study

Completed · Phase 4

Conditions studied: ADHD, Autism

In brief

The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).

Key facts

Study ID

NCT02255565

Run by

Seattle Children's Hospital

People needed

36

Starts

2014-09-01

Expected to finish

2016-10-01

Last updated by the study team

2017-08-01

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism Spectrum Disorder by DSM-V.
• A DSM-V diagnosis of ADHD based upon the K-SADS-P.
• Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating > 4.
• Findings on physical exam, labs and ECG are judged to be normal for age with pulse and blood pressure within 95% of age and gender mean.
• Informed consent by a parent or legal guardian, and assent for children with developmental age 7 years or older.
• At least one parent fluent in English

You may not qualify if…

• History of Seizure disorder (Febrile seizures are non-exclusionary).
• History of Intellectual Disability (IQ< 70)
• Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO Inhibitor).
• Other psychotropic medication other than stable dose of Selective Serotonin Reuptake Inhibitors, which is permitted)
• Known to be hypersensitive to methylphenidate, or other components of Quillivant XR
• Cardiac or other medical contraindications for stimulant trial (e.g., family history of heart attack at age younger than 40 years, personal history of heart disease, history of fainting while exercising, structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. If any doubt, children will be referred to a cardiologist for a cardiac clearance.
• Raynaud's disease
• Pregnancy or Breast-feeding.

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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