Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

Tracking Information
First Submitted Date ICMJE	September 9, 2005
First Posted Date ICMJE	September 14, 2005
Last Update Posted Date	January 28, 2014
Study Start Date ICMJE	February 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00166595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Official Title ICMJE	Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Brief Summary	The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in children in relation to side effects and clinical response to risperidone.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Child Development Disorders, Pervasive
Intervention ICMJE	Drug: Risperidone
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: September 9, 2005)	100
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2005
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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).; Patients with known renal or hepatic dysfunction (e.g. serum creatinine, and transaminases or bilirubin exceeding age specific upper range limits) are not eligible.; Failure of the parent/legal guardian to give informed consent.
Sex/Gender	Sexes Eligible for Study: All
Ages	4 Years to 21 Years (Child, Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00166595
Other Study ID Numbers ICMJE	PPRU 10545s
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Children's Hospital Medical Center, Cincinnati
Study Sponsor ICMJE	Children's Hospital Medical Center, Cincinnati
Collaborators ICMJE	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators ICMJE	Not Provided
PRS Account	Children's Hospital Medical Center, Cincinnati
Verification Date	July 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP