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)
Efficacy And Safety Of Risperidone In The Treatment Of Children With Autistic Disorder And Other Pervasive Developmental Disorders: A Canadian, Multicenter, Double-Blind, Placebo-Controlled Study
1 other identifier
interventional
80
0 countries
N/A
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 Pervasive Developmental Disorders (PDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 1999
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedJanuary 24, 2011
January 1, 2011
December 2, 2005
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Irritability Subscale of the Aberrant Behavior Checklist (ABC) and other ABC subscales at end of treatment compared with baseline
Secondary Outcomes (1)
Change from baseline to end of treatment in Nisonger Child Behavior Rating Form (N-CBRF), Visual Analogue Scale (VAS), and Clinical Global Impression (CGI); incidence of adverse events throughout study.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Shea S, Turgay A, Carroll A, Schulz M, Orlik H, Smith I, Dunbar F. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics. 2004 Nov;114(5):e634-41. doi: 10.1542/peds.2003-0264-F. Epub 2004 Oct 18.
PMID: 15492353RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Ortho Inc. Clinical Trial
Janssen-Ortho Inc., Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 5, 2005
Study Start
August 1, 1999
Study Completion
December 1, 2001
Last Updated
January 24, 2011
Record last verified: 2011-01