Conditions: ADHD Autism
Keywords: Quillivant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

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 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.

Arms:
arm 1: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. arm 2: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. arm 3: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.

Interventions: intervention 1: Very Low Dose Quillivant XR intervention 2: Low Dose Quillivant XR intervention 3: Moderate Dose Quillivant XR
Intervention descriptions: intervention 1: Oral suspension dose once a day increasing to a 10mg dose intervention 2: Oral suspension dose once a day increasing to a 20mg dose intervention 3: Oral suspension dose once a day increasing to a 40mg dose

Protocol document: