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	Intervention	Phase
Child Development Disorders, Pervasive	Drug: Risperidone	Phase I

Further Study Details: 

Expected Total Enrollment:  100

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.

Ages Eligible for Study:  5 Years   -   16 Years,  Genders Eligible for Study:  Both

Criteria

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00147394

Michigan
      Children''''s Hospital of Michigan/Wayne State University, Detroit,  Michigan,  48201,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27705,  United States; Recruiting
Ohio
      Cincinnati Children''''s Hospital, Cincinnati,  Ohio,  45229,  United States; Recruiting
      Rainbow Babies and Children''''s Hospital, Cleveland,  Ohio,  44106-6010,  United States; Recruiting
      The Ohio State University Medical Center, Columbus,  Ohio,  43210-1296,  United States; Recruiting

Study ID Numbers:  PPRU 10544
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147394
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13