Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Children With Autistic Disorder and Other Pervasive Developmental Disorders (PDD)
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
DCild Development Disorders, Pervasive
Autistic Disorder
Eligibility:
All Genders
5-12 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness of an oral solution of risperidone (an antipsychotic medication) versus placebo in the treatment of behavioral symptoms in children with Perva...
Detailed Description
The Pervasive Developmental Disorders (PDD) are a group of neuropsychiatric disorders, including autistic disorder, characterized by specific delays and deviance in social, communicative, and cognitiv...
Eligibility Criteria
Inclusion
- Diagnosis of Pervasive Developmental Disorders (Autistic Disorder, Rett's Disorder, Childhood Disintegrative Disorder, Asperger's Disorder, or Pervasive Development Disorder not Otherwise Specified) by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), Axis I criteria
- with a total score of \>=30 on the Childhood Autism Rating Scale (CARS)
- receiving treatment as an out-patient
- healthy on the basis of a physical examination, electrocardiogram (ECG), and medical history at start of the study.
Exclusion
- Diagnosis of schizophrenia or other psychotic disorders by DSM-IV criteria
- seizure during 3 months prior to study initiation or currently being treated with more than one anticonvulsant drug
- history of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles)
- neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
- known hypersensitivity, intolerance, or unresponsiveness to risperidone.
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00261508
Start Date
August 1 1999
End Date
December 1 2001
Last Update
January 24 2011
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