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

July 3, 2017 updated by: Mark Stein, Seattle Children's Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Methylphenidate HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
once a week for 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
once a week for 6 weeks
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.
once a week for 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Mark Stein, PhD, Seattle Children's

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (ESTIMATE)

October 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI185890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ADHD

Clinical Trials on Very Low Dose Quillivant XR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe