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

Information source: Seattle Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD; Autism

Intervention: Very Low Dose Quillivant XR (Drug); Low Dose Quillivant XR (Drug); Moderate Dose Quillivant XR (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seattle Children's Hospital

Official(s) and/or principal investigator(s):
Mark Stein, PhD, Principal Investigator, Affiliation: Seattle Children's

Overall contact:
Sophie Shonka, BS, Phone: 206-884-7838, Email: sophia.shonka@seattlechildrens.org

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: ADHD Rating Scale - IV

Secondary outcome: Clinical Global Impressions-ADHD - Severity and Improvement scales

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

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

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.

Locations and Contacts

Sophie Shonka, BS, Phone: 206-884-7838, Email: sophia.shonka@seattlechildrens.org

Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Libby Bliss, MA, Phone: 206-884-1488, Email: elizabeth.bliss@seattlechildrens.org
Mark A Stein, Ph.D, Principal Investigator
Additional Information

Related publications:

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.

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.

Landa RJ, Gross AL, Stuart EA, Faherty A. Developmental trajectories in children with and without autism spectrum disorders: the first 3 years. Child Dev. 2013 Mar-Apr;84(2):429-42. doi: 10.1111/j.1467-8624.2012.01870.x. Epub 2012 Oct 30.

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.

Stein, M.A. et al.

Starting date: September 2014
Last updated: September 29, 2014

Page last updated: August 23, 2015

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