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Pharmacogenomic Profiling of Pediatric Patients

NCT02770339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-02-20

No results posted yet for this study

Summary

The purpose of this study is to determine the proportion of children presenting to a pediatric emergency department with an acute mental health/behavioral crisis or clinical drug toxicity who have a "match" or "mismatch" between the genes for drug metabolizing enzymes and their current or recent drug therapy. The investigators will utilize a readily available and FDA-approved cheek swab DNA test --GeneSight®--in these children that categorizes patients into 3 different type of groups - RED, YELLOW, and GREEN based on individuals' abilities to metabolize psychotropic drugs . Specific objectives include:

* The relationship of genomic mismatch to serum drug concentrations, either low or high
* The proportion of children with a genomic mismatch who present to PED with intentional self-injury.
* The relationship between match versus mismatch and self- and caregiver-reported outcomes of functioning, drug efficacy, and drug tolerability.
* Examine the proportion of children/adolescents who present to PED with an adverse drug reaction to one or more psychotropic with a genomic mismatch.
* Quantify the specific adverse reactions related to a mismatch of genotypes.

Conditions

  • Mental Disorders
  • Metabolism Medication Toxicity
  • Pediatric Disorder

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Pallavi Ghosh, MD · University of Alabama at Birmingham

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-11-30
Completion
2017-11-30

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 NCT02770339 on ClinicalTrials.gov