Pharmacogenomics for Improving Pediatric ADHD Treatment

Stopped early · Not applicable

Conditions studied: Attention Deficit Disorders With Hyperactivity

In brief

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.

Key facts

Study ID

NCT03730870

Run by

Clinical and Translational Genome Research Institute, Inc.

People needed

21

Starts

2019-02-28

Expected to finish

2020-02-28

Last updated by the study team

2020-05-18

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Specialized Hospital — Hamilton, New Jersey, United States
• Children's Specialized Hospital — Mountainside, New Jersey, United States
• Children's Specialized Hospital — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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