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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)

Primary Purpose

DCild Development Disorders, Pervasive, Autistic Disorder, Developmental Disabilities

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
risperidone
Sponsored by
Janssen-Ortho Inc., Canada
About
Eligibility
Locations
Outcomes
Full info

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

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    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.

    Full Information

    First Posted
    December 2, 2005
    Last Updated
    January 20, 2011
    Sponsor
    Janssen-Ortho Inc., Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00261508
    Brief Title
    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)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen-Ortho Inc., Canada

    4. Oversight

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    DCild Development Disorders, Pervasive, Autistic Disorder, Developmental Disabilities, Asperger Syndrome, Rett Syndrome
    Keywords
    Risperidone, child development disorders, pervasive development disorders, autistic disorder, autism, developmental disabilities, antipsychotropic agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    risperidone
    Primary Outcome Measure Information:
    Title
    Change in the Irritability Subscale of the Aberrant Behavior Checklist (ABC) and other ABC subscales at end of treatment compared with baseline
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Ortho Inc. Clinical Trial
    Organizational Affiliation
    Janssen-Ortho Inc., Canada
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15492353
    Citation
    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.
    Results Reference
    result

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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)

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