Table 1.
Basic characteristics of RCTs of risperidone vs placebo in children and adolescents with ASD
| Study | Number of randomized patients | Age of subjects (years) | Study duration | Drug/dose | Diagnostic criteria | Response criteria | Relapse criteria | Outcome measures |
|---|---|---|---|---|---|---|---|---|
| McCracken et al12 | 101 | 5–17 | 8 weeks | Risperidone/flexible dose Weight <20 kg: maximal dose=as low as possible Weight 20–45 kg: maximal dose=2.5 mg/day Weight >45 kg: maximal dose=3.5 mg/day |
DSM-IV for autistic disorder | ≥25% reduction in the ABC-I score and CGI-I score=1 or 2 | ABC CGI-I CY-BOCS |
|
| Shea et al15 | 80 | 5–12 | 8 weeks | Risperidone/flexible dose (maximal dose=0.06 mg/kg per day) | DSM-IV for pervasive developmental disorders | ≥50% reduction in the ABC in at least two of the five ABC subscales with none of the other subscales presenting a ≥10% increase | ABC | |
| Troost et al32 | 24 | 5–17 | 8 weeks (discontinuation study) | Risperidone/flexible dose Weight <45 kg: maximal dose=2.5 mg/day Weight >45 kg: maximal dose=3.5 mg/day |
DSM-IV-TR for pervasive developmental disorders | ≥25% reduction in the ABC-I score and CGI-S score=1 or 2 | ≥25% increase in the ABC-I score and CGI-SC score=much worse or very much worse for ≥2 consecutive weeks | CGI-SC ABC |
| Research Units on Pediatric Psychopharmacology Autism Network29 | 38 | 8 weeks (discontinuation study) | Risperidone/flexible dose Weight <20 kg: maximal dose=as low as possible Weight 20–45 kg: maximal dose=2.5 mg/day Weight >45 kg: maximal dose=3.5 mg/day |
DSM-IV for autistic disorder | ≥25% reduction in the ABC-I score and CGI-I score=1 or 2 | ≥25% increase in the ABC-I score and CGI-I score=6 or 7 for ≥2 consecutive weeks | ABC-I CGI-I |
|
| Luby et al31 | 23 | 2.5–6 | 6 months | Risperidone/(0.5–1.5 mg/day) | DSM-IV for autism or PDD NOS | N/A | CARS CBCL GARS PLS-3 VABS |
|
| Nagaraj et al30 | 40 | Up to 12 | 6 months | Risperidone liquid suspension/1 mg/day | DSM-IV for autism | N/A | CARS CGAS(br.)VSMS |
|
| Kent et al16 | 66 | 5–17 | 6 weeks | Risperidone oral solution –Weight 20–,45 kg received 1.25 mg/day –Weight ≥45 kg received 1.75 mg/day |
DSM-IV for autistic disorder | ≥25% reduction in the ABC-I score | ABC-I, CGI-I, CGI-S, CY-BOCS |
Abbreviations: ABC, Aberrant Behavior Checklist; ABC-I, Aberrant Behavior Checklist for irritability subscale; ASD, autism spectrum disorder; CARS, Childhood Autism Rating Scale; CBCL, Childhood Behavior Checklist; CGAS, Children’s Global Assessment Scale; CGI-I, Clinical Global Impression-Improvement Scale; CGI-S, Clinical Global Impression-Severity; CGI-SC, Clinical Global Impression-Symptom Change; CY-BOCS, Children’s Yale-Brown Obsessive Compulsive Scale; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, fourth edition; GARS, Gilliam Autism Rating Scale; N/A, not available; PDD NOS, pervasive developmental disorder-not otherwise specified; PLS-3, Preschool Language Scale, Third Edition; RCTs, randomized controlled trials; TR, text revision; VABS, Vineland Adaptive Behavior Scale; VSMS, Vineland Social Maturity Scale.