- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00147394
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan/Wayne State University
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati CHildren's Hospital
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Cleveland, Ohio, United States, 44106-6010
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, United States, 43210-1296
- The Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
Investigators
- Principal Investigator: Alexander Vinks, Pharm.D., Ph.D., Children's Hospital Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Neurodevelopmental Disorders
- Disease
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
- Developmental Disabilities
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- PPRU 10544
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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