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).
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 and ADHD. The investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with ASD have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without ASD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Oral suspension dose once a day increasing to a 10mg dose
Oral suspension dose once a day increasing to a 20mg dose
Oral suspension dose once a day increasing to a 40mg dose
Seattle Children's Hospital
Seattle, Washington, United States
ADHD Rating Scale - IV
Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
Time frame: once a week for 6 weeks
Clinical Global Impressions-ADHD - Severity
The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
Time frame: once a week for 6 weeks
Clinical Global Impression - Improvement (CGI-I)
The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
Time frame: once a week for 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.