Pharmacogenomics for Improving Pediatric ADHD Treatment

Clinical and Translational Genome Research Institute, Inc.

Status: Terminated

Conditions: Attention Deficit Disorders With Hyperactivity

Treatments: Diagnostic Test: Pharmacogenomics report

Study type: Interventional

Funder types: Other

Identifiers

NCT03730870

2018-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Pharmacogenomics report

Experimental group

Description:

Clinician reviews pharmacogenomics report for subject prior to prescribing FDA-approved medications.

Treatment:

Diagnostic Test: Pharmacogenomics report

Control

No Intervention group

Description:

Clinician prescribes FDA-approved medications as customarily performed without additional guidance from pharmacogenomics report ("treatment-as-usual").