CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02770339
NCT02770339N/ACompleted

Pharmacogenomic Profiling of Pediatric Patients on Psychotropic Medications in an Emergency Department

University of Alabama at Birmingham·observational·Posted May 12, 2016·Updated Feb 20, 2018

In Brief

An observational study for Mental Disorders and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 12, 2016
Enrollment StartJun 1, 2016
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.1 years ago