Attention Deficit Disorders With Hyperactivity Clinical Trial
Official title:
Assessment of Pharmacogenomics Testing for Improving Pediatric ADHD Psychopharmacological Treatment: A Randomized Controlled Trial
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.
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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