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Pharmacogenomics for Improving Pediatric ADHD Treatment

NCT03730870 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-05-18

No results posted yet for this study

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.

Conditions

  • Attention Deficit Disorders With Hyperactivity

Interventions

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.

Sponsors & Collaborators

  • Children's Specialized Hospital

    collaborator OTHER

  • Clinical and Translational Genome Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Dan Handley, M.S., Ph.D. · Clinical and Translational Genome Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-12-31
Completion
2020-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730870 on ClinicalTrials.gov