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)
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ClinicalTrials.gov Identifier: NCT00261508 |
Recruitment Status
:
Completed
First Posted
: December 5, 2005
Last Update Posted
: January 24, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
DCild Development Disorders, Pervasive Autistic Disorder Developmental Disabilities Asperger Syndrome Rett Syndrome | Drug: risperidone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | August 1999 |
Actual Study Completion Date : | December 2001 |

- Change in the Irritability Subscale of the Aberrant Behavior Checklist (ABC) and other ABC subscales at end of treatment compared with baseline
- 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.

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Ages Eligible for Study: | 5 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261508
Study Director: | Janssen-Ortho Inc. Clinical Trial | Janssen-Ortho Inc., Canada |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00261508 History of Changes |
Other Study ID Numbers: |
CR006106 |
First Posted: | December 5, 2005 Key Record Dates |
Last Update Posted: | January 24, 2011 |
Last Verified: | January 2011 |
Keywords provided by Janssen-Ortho Inc., Canada:
Risperidone child development disorders pervasive development disorders autistic disorder |
autism developmental disabilities antipsychotropic agents |
Additional relevant MeSH terms:
Syndrome Rett Syndrome Asperger Syndrome Disease Autistic Disorder Developmental Disabilities Autism Spectrum Disorder Child Development Disorders, Pervasive Pathologic Processes Neurodevelopmental Disorders Mental Disorders Mental Retardation, X-Linked Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists |