Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147394
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2005-09-02
Brief Title:
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder PDD
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients usual daily dose The study is designed to look at how fast children absorb breakdown and eliminate risperidone
Detailed Description:
Pervasive Developmental Disorders is a category of disorders that includes autism and related conditions While these disorders are rare they represent a significant public health problem because they are extremely debilitating and lack efficacious therapies Neuroleptic use in PDD is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia Newer atypical neuroleptics including risperidone are now used in 87 of cases but dosing safety and efficacy is undetermined in the vulnerable population
This study consists of a total of 3 visits the initial screening visit where consent medical history demographics and vitals will be recorded Two additional visits with blood sampling will occur The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2
This study consists of a total of 3 visits the initial screening visit where consent medical history demographics and vitals will be recorded Two additional visits with blood sampling will occur The second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from Visit 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None