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)
DCild Development Disorders, Pervasive, Autistic Disorder, Developmental Disabilities
About this trial
This is an interventional treatment trial for DCild Development Disorders, Pervasive focused on measuring Risperidone, child development disorders, pervasive development disorders, autistic disorder, autism, developmental disabilities, antipsychotropic agents
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.