Pharmacogenomic Profiling of Pediatric Patients

NCT02770339 | Completed

• 1 other identifier: F160225002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacogenomics; Psychiatric crisis; Drug overdose; Psychotropic medications

Outcome Measures

Primary Outcomes (4)

• Psychiatric/Behavioral Crisis in Pediatric Emergency Department Genomic Mismatch

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

  Test result will be analyzed within 1 week of patient being enrolled

• Drug Concentration Genomic Mismatch

  The relationship between genomic mismatch in drug metabolizing enzymes and abnormal serum drug concentrations (either low or high).

  Drug concentrations will be measured within 3 months of enrollment

• Global Assessment of Functioning/Efficacy of Medications Genomic Mismatch

  The relationship between negative self- and caregiver-reported outcomes (global assessment of functioning, efficacy of medications) and genotype mismatch.

  Analysis of assessment scales/scores with pharmacogenomic test results will occur after enrollment is completed, average of 1 year

• Overdose of Drugs Genomic Mismatch

  The proportion of children/adolescents who present to PED with an overdose and psychotropic drug mismatch.

  Analysis of the association of subjects presenting with drug overdose with pharmacogenomic test results will occur after enrollment is completed, average of 1 year

Secondary Outcomes (2)

• Adverse Drug Reactions - Therapeutic Dose Genomic Mismatch

  Analysis of association between adverse drug reaction and genomic mismatch will occur after enrollment is completed, average of 1 year

• Clinical Toxicity Genomic Mismatch

  Analysis of any association between any clinical medication toxicity and genomic testing will occur after enrollment is completed, average of 1 year.

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects ages 3-18 years of age who present to the pediatric emergency department with an acute psychiatric /behavioral crisis who are also on 1 more psychotropic medications (antidepressants, antipsychotics, attention deficit hyperactivity disorder medications) will be eligible for enrollment.

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:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (7)

• Pittsenbarger ZE, Mannix R. Trends in pediatric visits to the emergency department for psychiatric illnesses. Acad Emerg Med. 2014 Jan;21(1):25-30. doi: 10.1111/acem.12282. Epub 2013 Dec 6.

  PMID: 24552521 BACKGROUND

• Olfson M, King M, Schoenbaum M. Treatment of Young People With Antipsychotic Medications in the United States. JAMA Psychiatry. 2015 Sep;72(9):867-74. doi: 10.1001/jamapsychiatry.2015.0500.

  PMID: 26132724 BACKGROUND

• Olfson M. Surveillance of adverse psychiatric medication events. JAMA. 2015 Mar 24-31;313(12):1256-7. doi: 10.1001/jama.2014.15743. No abstract available.

  PMID: 25803347 BACKGROUND

• Braga-Neto MB, Warren CA, Oria RB, Monteiro MS, Maciel AA, Brito GA, Lima AA, Guerrant RL. Alanyl-glutamine and glutamine supplementation improves 5-fluorouracil-induced intestinal epithelium damage in vitro. Dig Dis Sci. 2008 Oct;53(10):2687-96. doi: 10.1007/s10620-008-0215-0. Epub 2008 Mar 6.

  PMID: 18320312 BACKGROUND

• Altar CA, Carhart JM, Allen JD, Hall-Flavin DK, Dechairo BM, Winner JG. Clinical validity: Combinatorial pharmacogenomics predicts antidepressant responses and healthcare utilizations better than single gene phenotypes. Pharmacogenomics J. 2015 Oct;15(5):443-51. doi: 10.1038/tpj.2014.85. Epub 2015 Feb 17.

  PMID: 25686762 BACKGROUND

• Winner JG, Carhart JM, Altar CA, Goldfarb S, Allen JD, Lavezzari G, Parsons KK, Marshak AG, Garavaglia S, Dechairo BM. Combinatorial pharmacogenomic guidance for psychiatric medications reduces overall pharmacy costs in a 1 year prospective evaluation. Curr Med Res Opin. 2015;31(9):1633-43. doi: 10.1185/03007995.2015.1063483. Epub 2015 Jul 23.

  PMID: 26086890 BACKGROUND

• Hicks JK, Bishop JR, Sangkuhl K, Muller DJ, Ji Y, Leckband SG, Leeder JS, Graham RL, Chiulli DL, LLerena A, Skaar TC, Scott SA, Stingl JC, Klein TE, Caudle KE, Gaedigk A; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective Serotonin Reuptake Inhibitors. Clin Pharmacol Ther. 2015 Aug;98(2):127-34. doi: 10.1002/cpt.147. Epub 2015 Jun 29.

  PMID: 25974703 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected to store DNA for potential Genomic Data Sharing (GDS)( studies if further study is prompted by the results of this study.

MeSH Terms

Conditions

Mental Disorders; Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Pallavi Ghosh, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2016
• First Posted: May 12, 2016
• Study Start: June 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)