Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Children's Hospital Medical Center, Cincinnati
With
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
To the knowledge of the investigators there are no studies documenting the pharmacokinetics and pharmacogenetics of risperidone in children with PDD. Currently the PPRU network is conducting a PK study whose aim is to establish a new enantio-selective micro-assay methodology and to generate preliminary population PK data of risperidone and its metabolites in PDD. This study focuses on pharmacogenetic evaluation of PDD patients having little or no effect, those that are unusually sensitive and those experiencing drug toxicity/adverse events at standard risperidone dosages.
In this study two 5 ml blood samples will be drawn at a regulary scheduled PK visit. Alternatively pooled waste blood samples or a buccal swab can be obtained.
Age
4–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female patients between the ages of 4 and 21 years.
Patients meeting DSM-IV criteria for autistic disorder, Pervasive Developmental Disorder (PDD), or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS) and about to initiate clinical treatment or currently clinically treated with risperidone.
Patients about to initiate clinical treatment or currently clinically treated with risperidone, or currently on risperidone as a participant in one of the multi-site Research Unit for Pediatric Psychopharmacology (RUPP) protocols.
You may not be if
Children taking psychotropic or other medication that will significantly interact with target CYP 450 isoenzyme activity, such to the discretion of the principal investigator (PI).
Failure of the parent/legal guardian to give informed consent.
Clareo Health | Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
