Table 1.

Summary of risperidone treatment studies in children and adolescents with bipolar disorder or schizophrenia

Author (Year)	Diagnosis	Design	Age range (N)	Duration	Efficacy/Effectiveness
(Armenteros et al 1997)	Schizophrenia	Open label treatment with risperidone	11–18 (10)	6 weeks	PANSS, BPRS, CGI assessments –PANSS (total score) improvement = 19.9 points (p < 0.001 vs baseline) –BPRS improvement = 12.2 points (p = 0.003 vs baseline) –CGI improvement = 1.4 points (p = 0.007 vs baseline)
(Zalsman et al 2003)	Schizophrenia	Open label treatment with risperidone	15.5–20 (11)	6 weeks	PANSS, BPRS, CGI assessments –PANSS (total score) improvement = 26.5 points (p < 0.01 vs baseline) –BPRS improvement = 13.5 points (p < 0.01 vs baseline) –CGI improvement = 1.46 (p < 0.001 vs baseline)
(Gothelf et al 2003)	Schizophrenia	Open label treatment with risperidone (n = 17), olanzapine (n = 19), or haloperidol (n = 7)	14–20.5 (43)	8 weeks	PANSS assessment –PANSS (total score) improvement at week 8 = 16.3 points (risperidone), 10 points (olanzapine), and 19.9 points (haloperidol) (p < 0.001 for effect of time); no differences between medication groups (p = 0.99)
(Mozes et al 2006)	Schizophrenia	Open label treatment with risperidone (n = 13) or olanzapine (n = 12)	9–14 (25)	12 weeks	PANSS, BPRS, CGAS assessments –PANSS (total score) improvement at week 12 = 30.4 points (risperidone; p < 0.001 vs baseline) and 42.3 points (olanzapine; p < 0.001 vs baseline) –BPRS improvement at week 12 = 18.2 points (risperidone; p < 0.001) and 23.9 (olanzapine; p < 0.001) –CGAS improvement at week 12 = 1.85 (risperidone; p < 0.001 vs baseline) and 2.42 (olanzapine; p < 0.001 vs baseline) –p > 0.24 for all risperidone vs olanzapine comparisons
(van Bruggen et al 2003)	Schizophrenia	Randomized, fiexible dose treatment of risperidone 1– 8 mg/day (n = 24) or olanzapine 5–30 mg/day (n = 18)	16–28 (42)	6 weeks	PANSS assessment –PANSS (total score) improvement at week 6 = 15.0 points (risperidone; p < 0.05 vs baseline) and 15.1 points (olanzapine; p < 0.05 vs baseline) –No significant differences between treatment groups
(Sikich et al 2004)	Schizophrenia spectrum (n = 26), and psychosis spectrum affective disorders (bipolar disorder or major depressive disorder with psychotic features; n = 24)	Randomized, double blind fiexible dose study of risperidone 4.0 ± 1.2 mg/day (n = 19), olanzapine 12.3 ± 3.5 mg/day (n = 16) or haloperidol 5.0 ± 2.0 mg/day (n = 15)	8–19 (50)	8 weeks	BPRS-C, CGI-I, and CPRS assessments –BPRS-C improvement = 27 points (risperidone; p = 0.0018 vs baseline), 28 points (olanzapine; p = 0.0018 vs baseline), and 16 points (haloperidol; p = 0.012 vs baseline) –CPRS (total) improvement = 54 points (risperidone; p = 0.0018 vs baseline), 52 points (olanzapine; p = 0.0036 vs baseline), and 40 points (haloperidol; p = 0.285 vs baseline) –CGI Improvement = 1.9 points (risperidone; p = 0.0018 vs baseline), 2.0 points (olanzapine; p = 0.0018 vs baseline), and 1.3 points (haloperidol p = 0.075 vs baseline) –No statistically significant differences between treatment groups for any outcomes
(Haas et al 2007)	Schizophrenia	Randomized, double blind, placebo- controlled study of placebo (n = 15), risperidone 1– 3 mg/day (n = 55), or risperidone 4– 6 mg/day (n = 51)	13–17 (160)	6 weeks	PANSS assessment –Placebo improvement = 8.9 points –Risperidone 1–3 mg/day improvement = 21.3 points –Risperidone 4–6 mg/day improvement = 21.2 points –Risperidone (either dose range) improvement 3 placebo (p < 0.001)
(Frazier et al 1999)	Bipolar disorder	Retrospective study of risperidone 1.7 ± 1.3 mg/day	4–17 (28)	0.25–34 months	CGI-Severity assessments –CGI-Severity Mania score improvement = 2.5 points (p < 0.01 vs baseline) –CGI-Severity Aggression score improvement = 2.1 points (p < 0.01 vs baseline)
(Biederman et al 2005a)	Bipolar disorder	Open-label study of risperidone 0.25–2.0 mg/day (n = 16) or olanzapine 1.25–10 mg/day (n = 15)	4–6 (31)	8 weeks	YMRS, BPRS, CDRS –YMRS score improvement = 18.8 points (risperidone; p < 0.05 vs baseline), 12.1 points (olanzapine; p < 0.05 vs baseline) –BPRS score improvement = 13.1 points (risperidone; p < 0.05 vs baseline), 8.9 points (olanzapine; p < 0.05 vs baseline) –CDRS score improvement = 12.7 points (risperidone; p < 0.05 vs baseline), 8.3 points (olanzapine; p = NS vs baseline) –p = NS between treatment groups for primary outcomes
(Biederman et al 2005b)	Bipolar disorder	Open label study of risperidone 0.25–4.0 mg/day	6–17 (30)	8 weeks	YMRS, BPRS, and CDRS assessments –YMRS score improvement = 14.4 points (p < 0.0001 vs baseline) –BPRS score improvement = 12.6 points (p = 0.0002 vs baseline) –CDRS score improvement = 10.2 points (p = 0.0001 vs baseline)
(Pavuluri et al 2004a)	Bipolar disorder	Open label study of risperidone 0.25–3 mg/day+ lithium 0.6–1.0 mEq/day or divalproex sodium 50–120 μg/mL	5–18 (37)	6 months	YMRS and CGI-BP assessments –YMRS score improvement = 23.53 (risperidone + lithium), 22.0 (risperidone + divalproex sodium) (p < 0.0001 for effect of time; p = NS between treatments) –CGI-BP score improvement = 3.56 (risperidone + lithium) and 3.82 (risperidone + divalproex sodium) (p < 0.001 for effect of time; p = NS between treatments)

Abbreviations: PANSS, (Positive and Negative Symptoms Scale); BPRS, (Brief Psychiatric Rating Scale); CGI, (Clinical Global Impression Scale – Improvement); CGAS, (Children’s Global Assessment Scale); BPRS-C, (Brief Psychiatric Rating Scale for Children); CPRS, (Children’s Psychiatric Rating Scale); YMRS, (Young Mania Rating Scale); CGI-BP, (Clinical Global Impression Scale for Bipolar Disorder); CDRS-R, (Child Depression Rating Scale-Revised).