Pharmacogenomic Profiling of Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT02770339|
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : February 20, 2018
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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.
|Condition or disease|
|Mental Disorders Metabolism Medication Toxicity Pediatric Disorder|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Pharmacogenomic Profiling of Pediatric Patients on Psychotropic Medications in an Emergency Department|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
- Psychiatric/Behavioral Crisis in Pediatric Emergency Department Genomic Mismatch [ Time Frame: Test result will be analyzed within 1 week of patient being enrolled ]The proportion of children presenting with psychiatric/behavioral crises in the PED who have a drug-genotype mismatch
- Drug Concentration Genomic Mismatch [ Time Frame: Drug concentrations will be measured within 3 months of enrollment ]The relationship between genomic mismatch in drug metabolizing enzymes and abnormal serum drug concentrations (either low or high).
- Global Assessment of Functioning/Efficacy of Medications Genomic Mismatch [ Time Frame: Analysis of assessment scales/scores with pharmacogenomic test results will occur after enrollment is completed, average of 1 year ]The relationship between negative self- and caregiver-reported outcomes (global assessment of functioning, efficacy of medications) and genotype mismatch.
- Overdose of Drugs Genomic Mismatch [ Time Frame: Analysis of the association of subjects presenting with drug overdose with pharmacogenomic test results will occur after enrollment is completed, average of 1 year ]The proportion of children/adolescents who present to PED with an overdose and psychotropic drug mismatch.
- Adverse Drug Reactions - Therapeutic Dose Genomic Mismatch [ Time Frame: Analysis of association between adverse drug reaction and genomic mismatch will occur after enrollment is completed, average of 1 year ]The proportion of children/adolescents who present to PED with adverse drug reaction(s) to one or more who have a genomic mismatch with their psychotropic drugs.
- Clinical Toxicity Genomic Mismatch [ Time Frame: Analysis of any association between any clinical medication toxicity and genomic testing will occur after enrollment is completed, average of 1 year. ]To quantify the specific adverse reactions related to a mismatch of genotypes
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||3 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770339
|United States, Alabama|
|Children's of Alabama|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Pallavi Ghosh, MD||University of Alabama at Birmingham|
|Responsible Party:||Pallavi Ghosh, Principal Investigator, University of Alabama at Birmingham|
|Other Study ID Numbers:||
|First Posted:||May 12, 2016 Key Record Dates|
|Last Update Posted:||February 20, 2018|
|Last Verified:||February 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Based on the initial results with the GeneSight data, the researchers will decide if further analysis (genotype) of the DNA will be undertaken. The informed consent allows the participant to agree or disagree to having their blood stored for this additional analysis. Their decision does not affect their ability to participate in the research study. No personal identifiers will be associated with this analysis. If further analysis is done, the plan is to share through the NIH Genome Data Sharing program, according to its process.|