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Pharmacogenomics for Improving Pediatric ADHD Treatment

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ClinicalTrials.gov Identifier: NCT03730870
Recruitment Status : Suspended (This study's genetic testing laboratory has suspended operations pending discussions with the FDA concerning clinical interpretation of pharmacogenomics tests.)
First Posted : November 5, 2018
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Children's Specialized Hospital
Information provided by (Responsible Party):
Dan Handley, M.S., Ph.D., Clinical and Translational Genome Research Institute, Inc.

Brief Summary:
This research study is a randomized controlled trial (RCT) to test whether pharmacogenomics (PGx) testing for ADHD medications will help guide clinicians to choose medications and dosages for pediatric ADHD treatment that provide faster symptom relief, fewer or less severe side effects, improve patient quality of life, and lessen emotional stress for parents/guardians of the patients.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorders With Hyperactivity Diagnostic Test: Pharmacogenomics report Not Applicable

Detailed Description:

The study is a randomized controlled trial (RCT) of pediatric Attention Deficit Hyperactivity Disorder (ADHD) patients using an experimental group and a control group. The subjects in the experimental group will be administered a commercially available pharmacogenomics (PGx) test panel of 38 genes specifically related to drug metabolism rates and drug response. A subset of these genes are known to be involved in the pharmacokinetics and pharmacodynamics of ADHD medications.

The PGx test report indicates if there are genetic variants detected related to ADHD medications and consequently provides recommendations for the clinician on which medications and doses may be optimally effective. The control group is the "treatment as usual" (TAU) group whose subjects are treated with medications for ADHD based on the treating clinician's customary method(s) for selecting medications and doses.

The hypotheses to be tested are that PGx testing guidance will reduce the time it takes to reach a treatment regimen that improves patient symptom relief, reduces the frequency and severity of adverse drug reactions, improves patient quality of life, and reduces parental emotional stress. Additionally, since the test is performed using next-generation sequencing, we wish to tabulate relevant allele frequencies and use variant call files to discover previously unknown PGx genetic variants.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to have their study clinician have access to their pharmacogenomics report prior to prescribing medications (experimental group) or no access (control group) until end of the study.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Subjects will be blinded as to study arm participation and outcome assessments.
Primary Purpose: Treatment
Official Title: Assessment of Pharmacogenomics Testing for Improving Pediatric ADHD Psychopharmacological Treatment: A Randomized Controlled Trial
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharmacogenomics report
Clinician reviews pharmacogenomics report for subject prior to prescribing FDA-approved medications.
Diagnostic Test: Pharmacogenomics report
Intervention is the performance of a pharmacogenomics laboratory-developed test (LDT) performed by high-throughput sequencing of 38 genes involved in drug pharmacokinetics or pharmacodynamics. The clinician reviews the report results for each subject.

No Intervention: Control
Clinician prescribes FDA-approved medications as customarily performed without additional guidance from pharmacogenomics report ("treatment-as-usual").



Primary Outcome Measures :
  1. Assessment of Change in ADHD Symptom Severity Between Experimental and Control Group [ Time Frame: At baseline and at 24 weeks ]

    Measurement is performed by using the National Institute for Children's Health Quality (NICHQ) Vanderbilt Assessment Scales. The Vanderbilt assessment for ADHD is a validated questionnaire that provides a quantitative measure of ADHD symptoms and severity. Specific measures:

    Symptom Score: 18 questions on symptom type and severity between a measure of 0 (Never) and 3 (Very Often). Total Symptom Score range from 0 to 54. Lower scores indicate less severe symptoms.

    Performance Score: 8 questions on subject academic and interpersonal relationship functions using a measure between 1 (Excellent) and 5 (Problematic). Performance Score ranges from 0 to 40. Lower scores indicate better performance.

    Side Effects or Problems: 12 questions related to health and behavioral issues. Scores range from None, Mild, Moderate, to Severe. These are not quantitatively scored on the assessment.

    These measurements will be analyzed separately.

    This assessment is performed by parent/guardian.



Secondary Outcome Measures :
  1. Assessment of Differences in Parenting Stress Between Experimental and Control Group [ Time Frame: At baseline and at 24 weeks ]

    Measurement is performed using the Psychological Assessment Resources (PAR) Parenting Stress Index - 4th edition - Short Form for Parents of Children (ages 6-10) or Stress Index for Parents of Adolescents (ages 11-18) as appropriate for age at time of enrollment.

    Questionnaire for children ages 6 - 10 consists of 36 questions regarding problems with parental stress. Scale for each question ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Total scoring ranges from 36 to 180. Higher scores indicate less parenting stress.

    Questionnaire for adolescents ages 11 - 18 consists of 90 questions regarding problems with parental stress. Scale for each question ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Total scoring ranges from 90 to 450. Higher scores indicate less parenting stress.

    Assessment performed by parent/guardian.


  2. Assessment of Differences in Child's Quality of Life Between Experimental and Control Group [ Time Frame: At baseline and at 24 weeks ]

    Measurement is performed using the PedsQL Pediatric Quality of Life Inventory Parent-Proxy Report for Children (ages 5-7, 8-12, 13-18).

    Questionnaire consists of 23 questions regarding problems with subject's physical, emotional, social, and school functioning. Scale for each question ranges from 0 (Never) to 4 (Almost Always). Total scoring ranges from 0 to 92. Lower scores indicate higher quality of life.

    Assessment is performed by parent/guardian.


  3. Self-assessment of Differences in Child's Quality of Life Between Experimental and Control Group [ Time Frame: At baseline and at 24 weeks ]

    Measurement is performed using the PedsQL Pediatric Quality of Life Inventory Child-Self Report (ages 5-7, 8-12, 13-18).

    Questionnaire consists of 23 questions regarding problems with subject's physical, emotional, social, and school functioning. Scale for each question ranges from 0 (Never) to 4 (Almost Always). Total scoring ranges from 0 to 92. Lower scores indicate higher quality of life.

    Assessment performed by subject.



Other Outcome Measures:
  1. PGx Allele Frequency Tabulation [ Time Frame: 1 year from start of study ]
    Tabulation of allele frequencies associated with the PGx genes that are sequenced. This is intended to add to current knowledge of how prevalent relevant alleles are in the population.

  2. Analysis of variant call files for genetic variants [ Time Frame: 1 year from start of study ]
    Analysis of next-generation sequencing variant call files to determine whether the tests capture any previously unknown or undiscovered genetic variants, and assess their possible clinical significance.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between the ages of 6 and 18 inclusive at the start of the study.
  • Provision of signed and dated informed consent form.
  • Subject and parent or legal guardian must state willingness to comply with all study procedures and availability for the duration of the study.
  • Both male and female subjects will be recruited from the pediatric population diagnosed with any subtype of ADHD without Oppositional Defiant Disorder (ODD) via the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
  • Subject and their parent or legal guardian will read and speak English with sufficient proficiency to understand the study and be able to give informed assent and consent.
  • Subject will be able to complete study procedures such as filling out paper quality of life assessments
  • Subjects will be able to take oral medication(s) if and as prescribed.
  • Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

  • Subjects will not have been treated for any condition with psychiatric prescription medications within the previous six (6) months.
  • Subjects will not have had a diagnosis of Oppositional Defiant Disorder (ODD).
  • Subject will not be currently a suicide risk, has previously made a suicide attempt or has a prior history of suicidal behavior.
  • Subject will not have a history of alcohol or other substance abuse or dependence within the last 6 months.
  • Subject will not have used an investigational medicinal product or participation in a clinical study within six (6) months prior to the baseline visit.
  • Subject will not have a clinically important abnormality on urine drug and alcohol screen, if one had been taken.
  • If the subject is female, is not currently pregnant, reasonably expecting to become pregnant, or lactating.
  • Subject will not have a known or suspected allergy to any of the potential medications that may be prescribed.
  • Only one subject per family will be enrolled to prevent systematic bias based on a parent or legal guardian's personal style of symptom assessment.

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): NCT03730870


Locations
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United States, New Jersey
Children's Specialized Hospital
Hamilton, New Jersey, United States, 08619
Children's Specialized Hospital
Mountainside, New Jersey, United States, 07092
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755
Sponsors and Collaborators
Clinical and Translational Genome Research Institute, Inc.
Children's Specialized Hospital
Investigators
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Principal Investigator: Dan Handley, M.S., Ph.D. Clinical and Translational Genome Research Institute, Inc.

Publications:

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Responsible Party: Dan Handley, M.S., Ph.D., Chief Scientific Officer, Clinical and Translational Genome Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03730870     History of Changes
Other Study ID Numbers: 2018-01
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dan Handley, M.S., Ph.D., Clinical and Translational Genome Research Institute, Inc.:
Attention Deficit Disorders with Hyperactivity
ADHD
Pharmacogenomics
Pediatric ADHD
ADHD medications
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms