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Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00147394
First received: September 2, 2005
Last updated: October 25, 2012
Last verified: October 2012

September 2, 2005
October 25, 2012
December 2001
Not Provided
Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
Not Provided
Complete list of historical versions of study NCT00147394 on ClinicalTrials.gov Archive Site
Exploratory analysis will be performed to examine the relationship of other factors to risperidone and metabolite concentrations for PK/PD assessment.
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Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Child Development Disorders, Pervasive
Drug: Risperidone
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2004
Not Provided

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.
Both
5 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00147394
PPRU 10544
No
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Alexander Vinks, Pharm.D., Ph.D. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP