Status:
COMPLETED
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Pfizer
Conditions:
ADHD
Autism
Eligibility:
All Genders
5-16 years
Phase:
PHASE4
Brief Summary
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).
Detailed Description
To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in children with ASD a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02255565
Start Date
September 1 2014
End Date
October 1 2016
Last Update
August 1 2017
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105