Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147394
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : October 29, 2012
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

September 2, 2005
September 7, 2005
October 29, 2012
December 2001
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Quantify the variability of clearance and volume of distribution among AE rating, weight gain and ABC responder status.
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Complete list of historical versions of study NCT00147394 on 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.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Child Development Disorders, Pervasive
Drug: Risperidone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2004
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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.
Sexes Eligible for Study: All
5 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
PPRU 10544
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Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
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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