Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

Child Development Disorders, Pervasive Clinical Trial

Official title:

Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147394
• Other study ID #: PPRU 10544
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2005
• Last updated: October 25, 2012
• Start date: December 2001
• Est. completion date: June 2004

Study information

• Verified date: October 2012
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities

Intervention

Drug:
• Risperidone

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Children's Hospital of Michigan/Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
Secondary	Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.

External Links

•   Pediatric Pharmacology Research Unit Website