Rapporten - SBU

Table 3.3.2 continued
Author
Year
Reference
Country
Nagaraj et al
2006
[4]
India
Shea et al
2004
[2]
Canada
Aim Study design
Population
characteristics
Setting
Drop-outs
To study the
efficacy and safety
of risperidone in
young children
with autism with-
out any predefined
symptom subgroup
To evaluate the
efficacy and safety
of Risperidone for
the treatment of
behavioural symptoms
in children
with autistic and
other pervasive
development disorders
(PDD)
6 months treatment
of placebo-controlled
double-blind RCT
Children 2 to 9 years
40 children, of which
34 were boys
Advanced pediatric centre
of University clinic
1 drop-out
8 weeks double-blind
parallel-group placebo-
controlled multicentre RCT
Children 5–12 years
Male were 61 out of 79
7 investigational sites
1 drop-out
Intervention
method
Number of
individuals
Risperidone
starting with
0.5 mg daily
orally and
increased after
2 weeks to
1 mg daily.
n=19
Risperidone
oral solution 1.0
mg/mL administered
at 0.01 mg/
kg/day at start,
and maximum of
0.06 mg/kg/day.
n=40
ABC = Aberrant behavior checklist; CARS = Childhood autism rating scale; CGAS =
Childrens global assessment scale; CGI-I = Clinical global impression-improvement;
n = Number of patients; p = Probability coefficient; RCT = Randomised controlled trial
278 Autismspektrumtillstånd – diAgnostik och insAtser,
KAPITEL 3 • sysTEmATIsK LITTErATurövErsIKT –
279
vårdens orgAnisAtion och pAtientens delAktighet
Control
method
Number of
individuals
Placebo starting with
0.5 mg daily orally and
increased after 2 weeks
to 1 mg daily.
n=20
Placebo oral solution
1.0 mg/mL administered
at 0.01 mg/kg/day at start.
n=39
läkemedelsbehAndling med risperidon vid Ast
Results Study
quality
CARS
At least 20% improvement from baseline
for 12/19 vs 0/20
(p