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Table 1 Short-Term and Long-Term Studies of Risperidone in Pediatric Subjects With Disruptive Behavior Disorders (DBDs)

From: Evaluating movement disorders in pediatric patients receiving risperidone: a comparison of spontaneous reports and research criteria for TD

Citation

Population

Dosing

Duration

Results

Aman et al 2002 [8]

118 children aged 5–12 with DBDs and subaverage IQ

0.02–0.06 mg/kg/day RIS or PBO

6 weeks

Significant improvements over PBO by week 1 on the NCBRF conduct problem subscale; significant improvement over PBO on all other NCBRF subscales

Snyder et al 2002 [9]

110 children aged 5–12 with DBDs and subaverage IQ

0.02–0.06 mg/kg/day RIS or PBO

6 weeks

Significant improvements over PBO by week 1 on the NCBRF conduct problem subscale; significant improvement over PBO on all other NCBRF subscales

Findling et al 2004 [11]

107 children aged 5–14 with DBDs and subaverage IQ previously participating in a 6-week DB study

0.02–0.06 mg/kg/day RIS (mean dose, 1.64 mg/day)

1-year OL extension

Significant improvements on the NCBRF conduct problem subscale, most notably during the first 4 weeks; significant change from baseline on all other NCBRF subscales

Turgay et al 2002 [15]

77 children aged 5–12 with DBDs and subaverage previously participating in a 6-week DB study

0.02–0.06 mg/kg/day RIS (mean dose, 2.38 mg/day)

48-week OL extension

Significant improvements on the NCBRF conduct problem subscale in subjects previously receiving PBO in DB study; improvements were maintained in subjects previously treated with risperidone during DB study

Croonenberghs et al 2005 [10]

504 children aged 5–14 years with DBDs and subaverage IQ

0.02–0.06 mg/kg/day RIS (mean dose, 1.6 ± 0.03 mg/day)

1 year

Significant improvement on the NCBRF conduct problem subscale over baseline as early as week 1; improvements were maintained over the course of the study

Reyes et al 2006 [13]

48 children from [10] aged 7 to 15 with DBDs, subaverage IQ, and comorbid ADHD

0.02–0.06 mg/kg/day (mean dose, 1.83 mg/day)

12-month OL extension of Findling et al

Significant improvements on the NCBRF conduct problem subscale were maintained through the second year of treatment

Reyes et al 2006 [14]

35 children from [10] aged 5–15 years with DBDs, subaverage IQ, and comorbid ADHD

0.02–0.06 mg/kg/day (mean dose, 1.92 mg/day)

24-month OL extension of Findling et al

Symptoms continued to be well controlled, as measured by CGI

  1. IQ indicates intelligence quotient; RIS, risperidone; PBO, placebo; NCBRF, Nisonger Child Behavior Rating Form; DB, double-blind; OL, open-label; ADHD, attention-deficit/hyperactivity disorder; CGI, Clinical Global Impressions.