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Pharmacogenetics of Risperidone in PDD
NCT00166595Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2003
- Countries
- 1
- Sponsor
- Cincinnati Children's Hospital Medical Center
- Modality
- Small Molecules
- Drugs
- risperidone
- Conditions
- pervasive developmental disorder (PDD)
01
Overview
Phase 2, open-label, single-arm trial of risperidone in pervasive developmental disorder (PDD), sponsored by Cincinnati Children's Hospital Medical Center. Primary endpoint: Concentration of risperidone in the blood. Started Feb 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Risperidone Cohort
Patients with PDD treated with Risperidone
03
Who it enrols
Patients aged 4-21 with PDD/Autism currently treated with or about to start risperidone. Excludes those with renal/hepatic dysfunction or taking interacting medications.
04
Endpoints
Primary
Concentration of risperidone in the blood
Secondary
Clinical response to risperidone
Incidence of side effects
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