Pharmacogenomic Profiling of Pediatric Patients

Completed

Conditions studied: Mental Disorders, Metabolism Medication Toxicity, Pediatric Disorder

In brief

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.

Key facts

Study ID

NCT02770339

Run by

University of Alabama at Birmingham

People needed

100

Starts

2016-06-01

Expected to finish

2017-11-30

Last updated by the study team

2018-02-20

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children taking 1 or more antidepressant, antipsychotic, and/or attention deficit hyperactivity disorder medications.
• Children/adolescents who present with psychiatric/behavioral crisis or intentional overdose. This would include those referred for psychiatric evaluation, who may have behavioral problems (aggressive behavior, violent behavior), suicidal or homicidal thoughts, recent history of self-injury (with or without suicidal intent), depression, psychosis, anxiety, altered mental status, or violence.
• Children/adolescents who present to the PED with a suspected adverse drug reaction to any of the psychotropic/ADHD medications (toxicity).

You may not qualify if…

• Patients on the aforementioned medications who present to the PED with a chief complaint other than those listed in the inclusion criteria.
• Participants who present with acute intoxication with alcohol or drugs of abuse.
• Patients in Alabama Department of Human Resources (DHR) custody.
• Those with medical conditions that preclude participation.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.