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

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ClinicalTrials.gov Identifier: NCT02255565
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : June 5, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mark Stein, Seattle Children's Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
ADHD Autism Drug: Very Low Dose Quillivant XR Drug: Low Dose Quillivant XR Drug: Moderate Dose Quillivant XR Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Very Low Dose Quillivant XR
Oral suspension dose once a day increasing to a 10mg dose
Other Name: Methylphenidate HCl
Experimental: 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.
 Drug: Low Dose Quillivant XR
Oral suspension dose once a day increasing to a 20mg dose
Other Name: Methylphenidate HCl
Experimental: 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.
 Drug: Moderate Dose Quillivant XR
Oral suspension dose once a day increasing to a 40mg dose
Other Name: Methylphenidate HCl


Outcome Measures
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Primary Outcome Measures :
  1. ADHD Rating Scale - IV [ Time Frame: once a week for 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Clinical Global Impressions-ADHD - Severity [ Time Frame: once a week for 6 weeks ]
    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.

  2. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: once a week for 6 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255565


Locations
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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Pfizer
Investigators
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Principal Investigator: Mark Stein, PhD Seattle Children's
More Information
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Publications:
Rao, P. A. and R. J. Landa (2013).
Stein, M.A. et al.

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Responsible Party: Mark Stein, Director of ADHD/Related Disorders Program, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02255565    
Other Study ID Numbers: WI185890
First Posted: October 2, 2014    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: August 1, 2017
Last Verified: July 2017
Keywords provided by Mark Stein, Seattle Children's Hospital:
Quillivant
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
 Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents