Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT00147394

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Development Disorders, Pervasive	Drug: Risperidone	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder

Study Start Date :

Dec 1, 2001

Actual Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status. []

Secondary Outcome Measures

Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Michigan/Wayne State University	Detroit	Michigan	United States	48201
2	Duke University Medical Center	Durham	North Carolina	United States	27705
3	Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45229
4	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106-6010
5	The Ohio State University Medical Center	Columbus	Ohio	United States	43210-1296