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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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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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.

Condition

DCild Development Disorders, Pervasive

Intervention

risperidone


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

August 1999

Completion Date

December 2001


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.
      

Gender

All

Ages

5 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Janssen-Ortho Inc. Clinical Trial, , 



Administrative Informations


NCT ID

NCT00261508

Organization ID

CR006106



Study Sponsor

Janssen-Ortho Inc., Canada


Study Sponsor

Janssen-Ortho Inc. Clinical Trial, Study Director, Janssen-Ortho Inc., Canada


Verification Date

January 2011