The treatment of severe child aggression (TOSCA) study: Design challenges

Table 1 Dosing and Titration Guidelines

	OROS Methylphenidate		Risperidone
Day	< 25 kg	> 25 kg	Day	20-45 kg		> 45 kg
				AM	PM	AM	PM
1-4	18 mg	18 mg	1	-	0.5 mg	-	0.5 mg
5-7	18 mg	36 mg	4	0.5 mg	0.5 mg	0.5 mg	0.5 mg
8-11	36 mg	54 mg	8	0.5 mg	1.0 mg	0.5 mg	1.0 mg
12-14	54 mg	72 mg	11	-	-	1.0 mg	1.0 mg
15+	Maintenance; Dose reduction allowed for side effects		15	-	-	1.0 mg	1.5 mg
			16	1.0 mg	1.0 mg	-	-
			18	-	-	1.5 mg	1.5 mg
			22	1.0 mg	1.5 mg	1.5 mg	2.0 mg
			29	1.0 mg	1.5 mg	1.5 mg	2.0 mg

The study prescriber could vary from the guidelines as clinically indicated. In particular, the dose could be held constant or reduced for limiting side effects or if the clinical status left no room for further improvement.

ISSN: 1753-2000