title: Risperidone use in children with Down syndrome, severe intellectual disability, and comorbid autistic spectrum disorders: a naturalistic study.
abstract: OBJECTIVE
  We report on an open-label, naturalistic study using risperidone to treat disruptive behaviors and self-injury in children with Down syndrome, severe intellectual disability, and comorbid autism spectrum disorders (DS+ASDs). We hypothesized that hyperactivity and disruptive behaviors would improve in response to risperidone treatment consistent with previous studies of children with ASD.
  
  
  METHODS
  Subjects were children (mean age, 7.8 +/- 2.6 years), consisting of 20 males and three females identified through our outpatient Down Syndrome Clinic between 2000 and 2004.
  
  
  RESULTS
  Using the Aberrant Behavior Checklist as the primary outcome measure, all five subscales showed significant improvement following risperidone treatment. The mean duration of treatment was 95.8 +/- 16.8 days, and mean total daily dose was 0.66 +/- 0.28 mg/day. The Hyperactivity, Stereotypy, and Lethargy subscale scores showed the most significant reduction (p < .001), followed by Irritability (p < .02), and Inappropriate Speech (p < .04). Children with disruptive behavior and self-injury showed the greatest improvement. Sleep quality improved for 88% of subjects with preexisting sleep disturbance. Subjects for whom a follow-up weight was available showed a mean weight increase of 2.8 +/- 1.5 kg during the treatment period.
  
  
  CONCLUSIONS
  These findings support our clinical impression of improvement on important target behaviors such as aggression, disruptiveness, self-injury, stereotypy, and social withdrawal. Low-dose risperidone appears to be well tolerated in children with DS+ASD, although concerns about weight gain and metabolic alterations may limit its usefulness over the long term in some children.
authors: Division of Neurology and Developmental Medicine, Kennedy Krieger Institute, Baltimore, Maryland 21231, USA. capone@kennedykrieger.org
authors: George T
authors: GT
authors: Capone
authors: Parag
authors: P
authors: Goyal
authors: Marco
authors: M
authors: Grados
authors: Brandon
authors: B
authors: Smith
authors: Heather
authors: H
authors: Kammann
mesh_terms: D000293:Adolescent; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000517:prevention & control*; D001321:Autistic Disorder / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D004314:Down Syndrome / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D005260:Female; D006801:Humans; D008607:Intellectual Disability / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D016014:Linear Models; D008297:Male; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016728:Self-Injurious Behavior / Q000517:prevention & control*
chemical_list: D000697:Central Nervous System Stimulants; D018967:Risperidone