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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study

Conditions
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ADHD, Autism

Intervention / Treatment
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* Drug: Very Low Dose Quillivant XR
* Drug: Low Dose Quillivant XR
* Drug: Moderate Dose Quillivant XR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very Low Dose Quillivant XR<br>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. | Drug: Very Low Dose Quillivant XR<br>* Oral suspension dose once a day increasing to a 10mg dose<br>* Other names: Methylphenidate HCl;|
| Experimental: Low Dose Quillivant XR<br>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. | Drug: Low Dose Quillivant XR<br>* Oral suspension dose once a day increasing to a 20mg dose<br>* Other names: Methylphenidate HCl;|
| Experimental: Moderate dose Quillivant XR<br>Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. | Drug: Moderate Dose Quillivant XR<br>* Oral suspension dose once a day increasing to a 40mg dose<br>* Other names: Methylphenidate HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | once a week for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | once a week for 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quillivant