FREE TREATMENT REPORT
See ratings and reviews when you sign up for an account.
Exogenous and Endogenous Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics
This study is currently Recruiting
May 2010 By Children's Mercy Hospital Kansas City
First Recieved on May 6, 2010
Last Updated on May 6, 2010
Cytochrome P450 2D6 (CYP2D6) is an important enzyme in the body for breaking down many
medications that are commonly used in children of various ages. The purpose of this
proposal is to investigate the relative roles of development and genetic variation in CYP2D6
activity in school-aged children and adolescents with attention deficit and hyperactivity
disorder and health controls using the over-the-counter cough suppressant, dextromethorphan
or "DM", a standard probe for determining CYP2D6 phenotype. Embedded in the study design
are sub-studies to search for by-products of normal body metabolism that reflect differences
in enzyme activity, and a pharmacokinetic study to assess the consequences of CYP2D6 genetic
variation on the systemic exposure to medications used by this patient population.
Ultimately, the goal of the research is to personalize the use of medications in children by
selecting the appropriate dose of the correct medication for individual patients.
||Observational Model: Case Control, Time Perspective: Prospective
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Pediatric patients who have a primary diagnosis of ADHD, combined type, hyperactive impulsive, or inattentive type (ADD).
Healthy subjects: Age and gender matched subjects who do not meet any of the exclusion criteria
|Ages Eligible for Study:||7 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
- Males and females between 7 and 15 years of age.
- Inability to have blood drawn for the screening lab tests
- Current therapy with medications metabolized by or known to inhibit CYP2D6:
- sertraline (Zoloft?)
- paroxetine (Paxil?)
- venlafaxine (Effexor?)
- risperidone (Risperdal ?)
- loratadine (Claritin?)
- haloperidol (Haldol?)
- propafenone (Rythmol?)
- cimetidine (Tagamet?)
- over-the-counter diphenhydramine-containing drugs
- including Benadryl and generics and the cough and cold preparations Allegra?
- pro-drugs codeine
- oxycodone (Percodan?, Percocet?) that are converted by 2D6 into their active
- Illicit drug use, treatment within the past 2 months with paroxetine or fluoxetine,
or the past six months with terbinafine are also exclusion criteria.
- Inability or unwillingness to fast 2 hours prior to the study session
- Existence of diagnosis which may influence absorption and gastric emptying; such as
reflux , inflammatory bowel disease, or Crohn's disease.
- A demonstrated adverse reaction to previous dextromethorphan exposure
- Impaired hepatic or renal activity, or physical examination as determined by the Sub
- Body-mass index (BMI) <5th and >95th percentile
- Investigator: Steven Leeder, PharmD, PhD - Principal Investigator - The Children's Mercy Hospital
- The Children's Mercy Hospital
Kansas City, Missouri 64108 United States
- The University of Washington
Seattle, Washington 98195 United States