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.