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

Primary Purpose

ADHD, Autism

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Very Low Dose Quillivant XR

Low Dose Quillivant XR

Moderate Dose Quillivant XR

About this trial

This is an interventional treatment trial for ADHD focused on measuring Quillivant

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Very Low Dose Quillivant XR

Low Dose Quillivant XR

Moderate dose Quillivant XR

Arm Description

Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.

Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.

Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.

Outcomes

Primary Outcome Measures

ADHD Rating Scale - IV

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

Clinical Global Impressions-ADHD - Severity

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.

Clinical Global Impression - Improvement (CGI-I)

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.

Full Information

NCT ID

NCT02255565

First Posted

September 24, 2014

Last Updated

July 3, 2017

Sponsor

Seattle Children's Hospital

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02255565

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seattle Children's Hospital

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD, Autism

Keywords

Quillivant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Very Low Dose Quillivant XR

Arm Type

Experimental

Arm Description

Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.

Arm Title

Low Dose Quillivant XR

Arm Type

Experimental

Arm Description

Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.

Arm Title

Moderate dose Quillivant XR

Arm Type

Experimental

Arm Description

Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.

Intervention Type

Drug

Intervention Name(s)

Very Low Dose Quillivant XR

Other Intervention Name(s)

Methylphenidate HCl

Intervention Description

Oral suspension dose once a day increasing to a 10mg dose

Intervention Type

Drug

Intervention Name(s)

Low Dose Quillivant XR

Other Intervention Name(s)

Methylphenidate HCl

Intervention Description

Oral suspension dose once a day increasing to a 20mg dose

Intervention Type

Drug

Intervention Name(s)

Moderate Dose Quillivant XR

Other Intervention Name(s)

Methylphenidate HCl

Intervention Description

Oral suspension dose once a day increasing to a 40mg dose

Primary Outcome Measure Information:

Title

ADHD Rating Scale - IV

Description

Time Frame

once a week for 6 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impressions-ADHD - Severity

Description

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.

Time Frame

once a week for 6 weeks

Title

Clinical Global Impression - Improvement (CGI-I)

Description

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.

Time Frame

once a week for 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Stein, PhD

Organizational Affiliation

Seattle Children's

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16477513

Citation

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. doi: 10.1007/s10803-005-0060-3.

Results Reference

background

PubMed Identifier

17201617

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. doi: 10.1089/cap.2006.16.737.

Results Reference

background

Citation

Rao, P. A. and R. J. Landa (2013).

Results Reference

background

PubMed Identifier

16275814

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. doi: 10.1001/archpsyc.62.11.1266.

Results Reference

background

Citation

Stein, M.A. et al.

Results Reference

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

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