Table 2.

Inclusion and exclusion criteria for risperidone only versus risperidone + PT

Inclusion criteria

Outpatients, males and females between the ages of 4 and 13 years; body weight ≥15 kg

DSM-IV diagnosis of autistic disorder, Asperger's disorder, or pervasive developmental disorder-NOS (established by clinical assessment, corroborated by the Autism Diagnostic Interview-revised)

≥18 on parent-rated Irritability subscale of the Aberrant Behavior Checklist

≥Moderate on the Clinical Global Impressions Severity scale (clinical assessment)

Medication-free for at least 2 weeks for all psychotropic medications (4 weeks for fluoxetine or depot antipsychotics)

Stable seizure disorder as evidenced by stable dosage of anticonvulsant medication for at least 4 weeks and no seizures for at least 6 months

IQ of ≥35 as measured by the Stanford-Binet V, Revised Leiter, or Mullen

Exclusion criteria

Females with a positive Beta HCG pregnancy test

Evidence of a prior adequate trial of risperidone (at least 2 weeks of treatment at 1.5 mg/day)

Evidence of hypersensitivity to risperidone (defined as allergic response [e.g., skin rash])

History of neuroleptic malignant syndrome

DSM-IV diagnosis of Rett's Disorder, Childhood Disintegrative Disorder (clinical assessment and ADI-R)

Lifetime diagnosis of schizophrenia, another psychotic disorder, bipolar disorder (clinical assessment aided by Child and Adolescent Symptom Inventory)

Current psychiatric condition (e.g., depression) requiring an alternative treatment (clinical assessment aided by Child and Adolescent Symptom Inventory)

A significant medical condition identified by history, physical examination or laboratory tests