Risperidone monotherapy in preschool children with pervasive developmentaldisorders

The aim of this preliminary study was to examine the short-term efficacy an d safety of the atypical antipsychotic risperidone in preschool autistic ch ildren. The sample consisted of 10 subjects (7 males and 3 females) aged 3( 9)/(12) to 6(6)/(12) years (mean age 4.7 years). A 16-week open-label trial with risperidone monotherapy was initiated at a starting dose of 0.25 mg d aily and was increased to a maximum dose of 0.50 mg (0.027 mg/kg daily). Ou tcome measures were the Childhood Autism Rating Scale, the Children's Psych iatric Rating Scale, Clinical Global Impression (improvement score), and th e Children's Global Assessment of Functioning. Two subjects did not complet e the trial because of side effects (tachycardia and flushes, fever and hyp orexia). After the 16-week treatment, data from the eight children who comp leted the trial indicated a modest improvement in the Childhood Autism Rati ng Scale total score, Children's Psychiatric Rating Scale total score, and Children's Global Assessment of Functioning. According to the Clinical Glob al Impression, the global improvement score for four subjects was much impr oved or very much improved; the score for the other four children was minim ally improved. None of the children exhibited behavioral deterioration. The side effects in the eight children were not severe.