Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study
| Registry | NCT02255565 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 36 (Actual) |
| Sponsor | Seattle Children's Hospital (Other); collaborators: Pfizer |
| Conditions | ADHD, Autism |
| Interventions | Very Low Dose Quillivant XR, Low Dose Quillivant XR, Moderate Dose Quillivant XR (Drug) |
| Dates | start 2014-09-01, primary completion 2016-09-01, completion 2016-10-01, first posted 2014-10-02, last updated 2017-08-01 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for ADHD All trials for Autism All trials of Very Low Dose Quillivant XR All trials of Low Dose Quillivant XR
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Very Low Dose Quillivant XR | Experimental | Drug: Very Low Dose Quillivant XR | Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. |
| Low Dose Quillivant XR | Experimental | Drug: Low Dose Quillivant XR | Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. |
| Moderate dose Quillivant XR | Experimental | Drug: Moderate Dose Quillivant XR | Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. |
Sex: All, ages: 5 Years to 16 Years
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.
| Milestone | Very Low Dose Quillivant XR | Low Dose Quillivant XR | Moderate Dose Quillivant XR |
|---|---|---|---|
| Started | 9 | 9 | 9 |
| Completed | 9 | 8 | 9 |
| Not completed | 0 | 1 | 0 |
Time frame: 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Very Low Dose Quillivant XR | 0 | 0/9 (0.0%) | 8/9 (88.9%) |
| Low Dose Quillivant XR | 0 | 0/9 (0.0%) | 8/9 (88.9%) |
| Moderate Dose Quillivant XR | 0 | 0/9 (0.0%) | 9/9 (100.0%) |
| Term | Organ system | Very Low Dose Quillivant XR | Low Dose Quillivant XR | Moderate Dose Quillivant XR |
|---|---|---|---|---|
| Difficulty Falling Asleep | General disorders | 5/9 | 6/9 | 6/9 |
| Waking at Night | General disorders | 2/9 | 2/9 | 1/9 |
| Waking up Early | General disorders | 3/9 | 5/9 | 2/9 |
| Nightmares | General disorders | 1/9 | 0/9 | 1/9 |
| Flat Affect / No Emotion | Psychiatric disorders | 2/9 | 0/9 | 2/9 |
| Rebound at end of day | Psychiatric disorders | 4/9 | 4/9 | 5/9 |
| Aggression | Psychiatric disorders | 6/9 | 2/9 | 4/9 |
| Talks less | General disorders | 2/9 | 1/9 | 2/9 |
| Uninterested | General disorders | 2/9 | 1/9 | 4/9 |
| Decreased Appetite | General disorders | 3/9 | 6/9 | 4/9 |
| Irritable | General disorders | 7/9 | 4/9 | 4/9 |
| Hostility | General disorders | 6/9 | 3/9 | 5/9 |
| Stomachaches | General disorders | 2/9 | 2/9 | 0/9 |
| Headaches | General disorders | 2/9 | 0/9 | 0/9 |
| Drowsiness | General disorders | 1/9 | 2/9 | 3/9 |
| Sad/Unhappy | General disorders | 1/9 | 1/9 | 0/9 |
| Prone to Crying | General disorders | 4/9 | 3/9 | 1/9 |
| Anxious/worries | General disorders | 3/9 | 3/9 | 2/9 |
| Bites Fingernails | General disorders | 2/9 | 1/9 | 1/9 |
| Picking | General disorders | 1/9 | 1/9 | 3/9 |
| Euphoric/Happy | General disorders | 3/9 | 3/9 | 5/9 |
| Nausea | General disorders | 1/9 | 2/9 | 0/9 |
| Tics | Psychiatric disorders | 2/9 | 2/9 | 3/9 |
| Jittery or nervous | General disorders | 2/9 | 2/9 | 1/9 |
| Mood Swings/Lability | General disorders | 5/9 | 3/9 | 3/9 |
| Fatigue | General disorders | 1/9 | 2/9 | 1/9 |
| Constipation | Gastrointestinal disorders | 2/9 | 3/9 | 0/9 |
| Stares A Lot | General disorders | 0/9 | 2/9 | 3/9 |
| Abdominal pain | General disorders | 0/9 | 1/9 | 0/9 |
| Rash | General disorders | 0/9 | 1/9 | 3/9 |
| Vomiting | Gastrointestinal disorders | 0/9 | 1/9 | 0/9 |
| Cold Hands and Feet | General disorders | 0/9 | 0/9 | 1/9 |
Limitations and caveats: No placebo was available for comparison to Quillivant XR. Small sample size.
| Facility | City | Country | Status |
|---|---|---|---|
| Seattle Children's Hospital | Seattle, Washington | United States |