Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD
Study
Inclusion/Exclusion Baseline
Description Intervention
Criteria/Population Measures Outcomes
Author: Intervention:
Inclusion criteria: Overall ratings: 4- month open label
RUPP, 2005 Part 1: 4 month open- • Children meeting DSM- Extension phase: extension phase:
Country: label Rx with
IV criteria for autistic (end of initial 8
US
Risperidone, starting at disorder, with tantrums, weeks of
ABC-C, mean ± SD:
Practice the optimal dose
aggression, self- medication Irritability:
setting: Part 2: 8 week
injurious behavior, or a exposure) : (n=63) G1: 11.7 ± 8 ; F = 5.35,
Academic randomized double-blind combina-tion of these
P = 0.028
centers gradual placebo-
problems
ABC-C, mean ± Lethargy / social
Intervention substitution for
• Aged 5 to 17 years SD:
withdrawal:
setting: risperidone
• Weight ≥ 15 kg Irritability: G1: 6.8 ± 5.9; F = 2.61,
Clinic
• Mental age ≥ 18 months G1: 9.5 ± 6.8 P = NS
Enrollment Open label extension • Clinically significant Social withdrawal: Stereotypy:
period: phase intervention behavioral problems G1: 7.3 ± 5.4 G1: 5.8 ± 4.7; F = 5.47,
June 1999 to (16 weeks):
with clinician-
Stereotypy: P = 0.02
April 2001 Responders from the determined rating of ≥ G1: 4.9 ± 4.3 Hyperactivity:
Funding: RCT or the extension moderate on CGI-S and Hyperactivity: G1: 15.8 ± 10.2; F =
NIH; Kor-czak trial were invited to score ≥ 18 on ABC G1: 15.1 ± 10 0.43, P = NS
Foundation; continue into the open Irritability subscale Inappropriate Inappropriate speech:
Janssen label extension
rated by parent and speech:
G1: 3.4 ± 3.2 ; F = 0.39,
(provided study
confirmed by caregiver G1: 3.4 ± 3.6 P = NS
medication) Clinicians were allowed (children reassessed at
Author industry to adjust the total daily baseline, 7-14 days CGI Improvement CGI Improvement
relationship dose according to after initial assessment score, n (%): score, n (%)
disclosures: response and side to confirm first values) G1:
G1:
NR
effects, up to a maximum Exclusion criteria: Very much Very much improved: 19
of 3.5 mg/day for
• Serious medical
improved: 19 (30.2) (30.2)
Design: children weighing 15-45 disorders
Much improved: 42 Much improved: 33
Open label kg and up to 4.5 mg/ day
• Other psychiatric
(66.7)
(52.4)
extension phase for children > 45 kg
disorders requiring
Minimally Minimally improved: 6
followed by RCT Last values were carried
medication
improved: 0 (0.0) (9.5)
discontinuation forward for individuals
No change: 2 (3.2) No change: 0 (0.0)
• Children receiving a
phase
not completing this
Worse: 0 (0.0) Worse: 3 (4.8)
psychotropic drug that
phase
Much worse: 0 Much worse: 2 (3.2)
was deemed effective
(0.0)
for the treatment of
Mean risperidone dose
RCT participants:
aggression, tantrums,
at week 0= 1.96 mg/day.
Discontinuation Relapse during
or self-injurious
Mean risperidone dose
phase
discontinuation phase, n
behavior
at week 16=2.08 mg/day
participants, (%):
Age, years (mean ± sd):
(6% increase over 4
mean ± SD: (n=38) G1: 2/16 (12.5)
8.6 ± 2.8 (5-17), n=63
month period)
ABC-hyperactivity: G2: 10/16 (62.5)
Mental age:
Randomized
34.4 ± 8.7 G1/G2: P = 0.01
Mental development, n
discontinuation phase
ABC-Irritability:
(%):
(8 weeks):
27.6 ± 6.1 Time to relapse,
IQ: Average or above
Participants randomized
discontinuation phase,
average: 3 (4.8)
to risperidone or
median days:
Borderline: 7 (11.1)
placebo.
G1: 57
Mild retardation: 17 (27)
Placebo group had
G2: 34
Moderate: 12 (19)
risperidone replaced by
Severe: 11 (17.5)
placebo by 25% each
Harms (n=63), %:
Profound: 7 (11.1)
week for the first four
Nasal congestion: 11.1
Unable to assess: 6 (9.5)
weeks; enrollment halted
Appetite increase: 7.9
Gender: n (%):
after 32 participants were
Coughing: 6.3
Male: 49 (77.8)
randomized (interim
safety review indicated
significantly increased
relapse rate among
placebo vs. risperidone
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