Mental Disorders Clinical Trial
Official title:
Pharmacogenomic Profiling of Pediatric Patients on Psychotropic Medications in an Emergency Department
Verified date | February 2018 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's of Alabama | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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. — View Citation
Braga-Neto MB, Warren CA, Oriá 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. — View Citation
Hicks JK, Bishop JR, Sangkuhl K, Müller 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. Review. — View Citation
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. — View Citation
Olfson M. Surveillance of adverse psychiatric medication events. JAMA. 2015 Mar 24-31;313(12):1256-7. doi: 10.1001/jama.2014.15743. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Adverse Drug Reactions - Therapeutic Dose Genomic Mismatch | 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. | Analysis of association between adverse drug reaction and genomic mismatch will occur after enrollment is completed, average of 1 year | |
Secondary | Clinical Toxicity Genomic Mismatch | To quantify the specific adverse reactions related to a mismatch of genotypes | Analysis of any association between any clinical medication toxicity and genomic testing will occur after enrollment is completed, average of 1 year. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Recruiting |
NCT06012149 -
Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry
|
N/A | |
Recruiting |
NCT03222375 -
SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism
|
N/A | |
Active, not recruiting |
NCT02836080 -
Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
|
N/A | |
Active, not recruiting |
NCT02907658 -
Efficacy of Internet Use Disorder Prevention
|
N/A | |
Completed |
NCT02710344 -
Using Telehealth to Improve Psychiatric Symptom Management
|
N/A | |
Enrolling by invitation |
NCT02487888 -
A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care
|
N/A | |
Recruiting |
NCT02292056 -
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
|
N/A | |
Active, not recruiting |
NCT02761733 -
The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers
|
N/A | |
Completed |
NCT01947283 -
Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
|
N/A | |
Completed |
NCT01690013 -
Life Quality and Health in Patients With Klinefelter Syndrome
|
N/A | |
Completed |
NCT01633138 -
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
|
N/A | |
Completed |
NCT01656707 -
Adaptive Treatment for Adolescent Cannabis Use Disorders
|
N/A | |
Completed |
NCT01415323 -
Agitation in the Acute Psychiatric Department
|
||
Completed |
NCT01701765 -
Outcomes and Discharge of Long-stay Psychiatric Patients
|
N/A | |
Completed |
NCT00375167 -
Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery
|
N/A | |
Terminated |
NCT00757497 -
Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
|
Phase 1 | |
Terminated |
NCT03527550 -
Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
|
N/A | |
Withdrawn |
NCT03518996 -
Non-Invasive Brain Stimulation and Delirium
|
N/A |