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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261508
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : January 24, 2011
Information provided by:
Janssen-Ortho Inc., Canada

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).

Condition or disease Intervention/treatment Phase
DCild Development Disorders, Pervasive Autistic Disorder Developmental Disabilities Asperger Syndrome Rett Syndrome Drug: risperidone Phase 3

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 cognitive development with an onset typically in the first years in life. Children with PDD may show multiple, serious symptoms including hyperactivity, inattention, impulsive and aggressive behavior, repetitive movements or speech patterns, sleep disorders, screaming, and self-injurious behavior. Drug studies to date have suggested that different behavioral symptoms of PDDs respond to neuroleptics, such as risperidone. This is a randomized, double-blind, placebo-controlled study to evaluate the effectiveness of risperidone (0.02 to 0.06 mg/kg/day) compared with placebo in the treatment of behavioral symptoms in children 5 to 12 years of age with Pervasive Developmental Disorders (PDD). Patients receive study medication (risperidone or placebo) to be taken orally once a day at gradually increasing doses up to a maximum of 0.06 mg/kg, adjusted at weekly intervals to achieve optimal effectiveness while minimizing any intolerance to the drug. Treatment continues at the optimal dose through Week 8. A parent or caregiver evaluates the child's behavior and symptoms at scheduled office visits during the course of treatment. The primary measure of effectiveness is the change in the Irritability Subscale of the Aberrant Behavior Checklist (ABC) and other ABC subscales at end of treatment compared with baseline. Additional assessments of effectiveness include: the Nisonger Child Behavior Rating Form (N-CBRF); the Visual Analogue Scale (VAS), a measure of the patient's most disturbing symptom; and the Clinical Global Impression (CGI) of the overall severity of the disorder. Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (pulse, temperature, blood pressure), body weight, and evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale (ESRS) at specified intervals; clinical laboratory tests (hematology, biochemistry, urinalysis) before study initiation and at the end of treatment. The study hypothesis is that risperidone is more effective than placebo for the treatment of behavioral symptoms in children aged 5 to 12 years with Pervasive Developmental Disorders (PDD). Risperidone oral solution 1 mg/mL or placebo, taken orally, once daily. Days 1 - 2, dose is 0.01 mg/kg body weight. Days 3 - 7 dose is 0.02 mg/kg, increasing on Days 8 - 14 to 0.04 mg/kg (maximum), and 0.06 mg/kg (maximum) through 8 weeks. Dosage may be adjusted at investigator's discretion.

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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

Primary Outcome Measures :
  1. Change in the Irritability Subscale of the Aberrant Behavior Checklist (ABC) and other ABC subscales at end of treatment compared with baseline

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00261508

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
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Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
Publications of Results:
Layout table for additonal information Identifier: NCT00261508    
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:
child development disorders
pervasive development disorders
autistic disorder
developmental disabilities
antipsychotropic agents
Additional relevant MeSH terms:
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Rett Syndrome
Autistic Disorder
Developmental Disabilities
Autism Spectrum Disorder
Asperger Syndrome
Pathologic Processes
Child Development Disorders, Pervasive
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
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