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More info
You can access this
clinical trial
if you have
Mental Disorders, Metabolism Medication Toxicity or Pediatric Disorder
and you are
between 3 and 18
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

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.
Tris trial is registered with FDA with number: NCT02770339. The sponsor of the trial is University of Alabama at Birmingham and it is looking for 100 volunteers for the current phase.
Official trial title:
Pharmacogenomic Profiling of Pediatric Patients on Psychotropic Medications in an Emergency Department