NCT02255565

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 5, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

September 24, 2014

Results QC Date

March 7, 2017

Last Update Submit

July 3, 2017

Conditions

ADHDAutism

Keywords

Quillivant

Outcome Measures

Primary Outcomes (1)

  • 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.

    once a week for 6 weeks

Secondary Outcomes (2)

  • Clinical Global Impressions-ADHD - Severity

    once a week for 6 weeks

  • Clinical Global Impression - Improvement (CGI-I)

    once a week for 6 weeks

Study Arms (3)

Very Low Dose Quillivant XR

EXPERIMENTAL

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

Low Dose Quillivant XR

EXPERIMENTAL

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

Moderate dose Quillivant XR

EXPERIMENTAL

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

Interventions

Very Low Dose Quillivant XRDRUG

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

Also known as: Methylphenidate HCl
Very Low Dose Quillivant XR
Low Dose Quillivant XRDRUG

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

Also known as: Methylphenidate HCl
Low Dose Quillivant XR
Moderate Dose Quillivant XRDRUG

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

Also known as: Methylphenidate HCl
Moderate dose Quillivant XR

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

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

    PMID: 16477513BACKGROUND

  • 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.

    PMID: 17201617BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 16275814BACKGROUND

  • Stein, M.A. et al.

    BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAutistic Disorder

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

No placebo was available for comparison to Quillivant XR. Small sample size.

Results Point of Contact

Title
Dr. Mark Stein
Organization
Dept. of Psychiatry, University of Washington
mstein42@uw.edu
206-987-1161

Study Officials

  • Mark Stein, PhD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of ADHD/Related Disorders Program

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 2, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

August 1, 2017

Results First Posted

June 5, 2017

Record last verified: 2017-07

Locations

US(1)