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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02255565
• Other study ID #: WI185890
• Status: Recruiting
• Phase: Phase 4
• First received: September 24, 2014
• Last updated: April 13, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Seattle Children's Hospital
• Contact: Sophie Shonka, BS
• Phone: 206-884-7838
• Email: sophia.shonka[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Autism
• Autistic Disorder

Intervention

Drug:
• Very Low Dose Quillivant XR
Oral suspension dose once a day increasing to a 10mg dose
• Low Dose Quillivant XR
Oral suspension dose once a day increasing to a 20mg dose
• Moderate Dose Quillivant XR
Oral suspension dose once a day increasing to a 40mg dose

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. — View Citation

Stein, M.A. et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Rating Scale - IV	Obtains parent ratings regarding the frequency of each ADHD symptom based on DSM-IV criteria	Measure changes from baseline once a week for 6 weeks	No
Secondary	Clinical Global Impressions-ADHD - Severity and Improvement scales	A clinician rated 7-point scale that describes the severity of ADHD symptoms or improvement (or worsening) of ADHD symptoms as compared to baseline.	Measure changes from baseline once a week for 6 weeks	No