A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder
Condition: Autistic Disorder; Autism
MeSH terms: Autistic Disorder
Intervention: Placebo; Risperidone high dose; Risperidone low dose
Intervention description: Oral solution qd or bid for 6 weeks; Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) qd or bid for 6 weeks; Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) qd or bid for 6 weeks
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Irritability; Risperidone; Antipsychotic agent; Autism; Adolescents; Children

Summary:

      The purpose of this study is to evaluate the effectiveness (change in level of irritability
      and related behaviors) and safety and tolerability of the administration of 2 different fixed
      dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children
      or adolescents who have autism, and to evaluate the safety and tolerability of the drug for
      additional 26 weeks after the initial 6-week study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of Autistic Disorder (299.00)

          -  ABC-I Subscale score of greater than or equal to 18

          -  CGI-S of greater than or equal to 4

          -  mental age >18 months, body weight of at least 20 kg, seizure-free for at least 6
             consecutive months and if on anticonvulsants must be on a dosage that has been stable
             for at least 4 weeks

          -  Medication free for 1 week before the start of the study for all psychotropic drugs,
             except 4 weeks for fluoxetine and at least 8 weeks for injectable medications

          -  Female patients must be premenarchal or sexually abstinent or, if heterosexually
             active, must practice an effective method of birth control.

        Exclusion Criteria:

          -  History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar
             disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified
             (PDD NOS), Asperger's, or Rett's

          -  Any history of hypersensitivity to risperidone, or its excipients in formulation, or
             other known drug allergy

          -  Patients who received risperidone within 3 months before screening (except p.r.n. use)

          -  Patients who did not demonstrate sufficient clinical response to an adequate trial of
             risperidone treatment in the past (an adequate trial is defined as a period of at
             least 4 weeks at an adequate dose)

          -  Neurologic disorder (e.g., Neuroleptic Malignant Syndrome, seizure disorders that are
             unstable, seizure activity within the past 6 months)

          -  History of alcohol or substance dependence within 3 months of screening

          -  Female subject who is pregnant (positive beta-HCG) or breast feeding

          -  Patients with existing moderate or severe EPS or history of tardive dyskinesia

          -  Patients who have received an experimental drug or used an experimental medical device
             within 3 months before the planned start of treatment.