Phase 4
Completed N=27
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Source: ClinicalTrials.gov NCT02255565 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: ADHD Rating Scale - IV — 17.89; 16.78; 16.67; 14.33 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD Rating Scale - IV |
17.89; 16.78; 16.67; 14.33; 14.56; 12.89 | — |
| SECONDARY Clinical Global Impressions-ADHD - Severity |
4.78; 4.33; 4.44; 4.33; 4.11; 4.00 | — |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
3.89; 3.56; 3.44; 3.22; 3.00; 2.89 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02255565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.