Clinical trial NCT02255565: Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Official title: Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Autism
Keywords: Quillivant
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-10-02
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: ADHD Rating Scale - IV
timeFrame: once a week for 6 weeks
Secondary outcomes:
measure: Clinical Global Impressions-ADHD - Severity
timeFrame: once a week for 6 weeks
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: once a week for 6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Mark Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gadow KD, DeVincent CJ, Pomeroy J. ADHD symptom subtypes in children with pervasive developmental disorder. J Autism Dev Disord. 2006 Feb;36(2):271-83. doi: 10.1007/s10803-005-0060-3.
citation: Lee DO, Ousley OY. Attention-deficit hyperactivity disorder symptoms in a clinic sample of children and adolescents with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Dec;16(6):737-46. doi: 10.1089/cap.2006.16.737.
citation: Rao, P. A. and R. J. Landa (2013).
citation: Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry. 2005 Nov;62(11):1266-74. doi: 10.1001/archpsyc.62.11.1266.
citation: Stein, M.A. et al.