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NCT02770339 · ClinicalTrials.gov registry record

Pharmacogenomic Profiling of Pediatric Patients

A clinical trial, sponsored by University of Alabama at Birmingham.

Completed
Registry status
100
Enrollment target

NCT02770339: Completed study, sponsored by University of Alabama at Birmingham.

NCT02770339 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02770339 has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
100 participants
Enrollment target

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.

Primary Outcome

The proportion of children presenting with psychiatric/behavioral crises in the PED who have a drug-genotype mismatch

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2016-06
Est. Completion 2017-11-30
University of Alabama at Birmingham

1,160 total trials

What the finished NCT02770339 record still lists

NCT02770339 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT02770339 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02770339 about?

NCT02770339 is a clinical study titled "Pharmacogenomic Profiling of Pediatric Patients". 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 dru...

What is the current status of trial NCT02770339?

This trial is currently completed. The enrollment target is 100 participants. The study started on 2016-06. Estimated completion is 2017-11-30.

Who is sponsoring clinical trial NCT02770339?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02770339, the US trial registry maintained by the National Library of Medicine. NCT02770339 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.