Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
1 other identifier
interventional
100
1 country
5
Brief Summary
The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. The study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2001
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedOctober 29, 2012
October 1, 2012
September 2, 2005
October 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
Secondary Outcomes (1)
Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients between ages of 5 and less than 17 years.
- Patients meeting DSM-IV criteria for PDD-NOS about to initiate clinical treatment or currently clinically treated with risperidone.
- Patients with autistic disorder or PDD-NOS currently on risperidone as a participant in one of the multi-site RUPP protocols.
You may not qualify if:
- Children taking psychotropic or other medication that will interact with target CYP 450 isoenzyme activity will not be eligible for the pharmacokinetic study (i.e. CYP2D6 or CYP3A4; to be decided by the PI)
- Patients with known renal or hepatic dysfunction (e.g. serum creatinine \> 1.5 normal upper limit, transaminases or bilirubin \> 2 times normal upper limit)
- Failure of the parent/legal guardian to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Children's Hospital of Michigan/Wayne State University
Detroit, Michigan, 48201, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-6010, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210-1296, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Vinks, Pharm.D., Ph.D.
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
December 1, 2001
Study Completion
June 1, 2004
Last Updated
October 29, 2012
Record last verified: 2012-10