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: Problem behavior: Problem
Shea et al., 2004 Risperidone oral solution • Physically healthy ABC score, mean ± behavior:
Pandina et al., 1.0 mg/mL once daily in outpatients
SD:
ABC score, mean
2007†
the morning at 0.01 • Ages 5-12 years Irritability:
Country: mg/kg/day on treatment • DSM-IV Axis 1 diagnosis G1: 18.9 ± 8.8
Canada
days 1-2, increased to of PDD
G1a: 20.6 ± 8.1
Practice 0.02 mg/kg/day on day 3. • CARS total score ≥ 30 (n=24)†
setting:
Depending on response with or without mental G2: 21.2 ± 9.7
Academic, tertiary at day 8, could be
retardation
G2a: 21.6 ± 10.2†
care hospital, increased in increments Exclusion criteria: Lethargy:
pharmaceutical up to 0.02 mg/kg/day. • Schizophrenia
G1: 13.7 ± 7.0
company, contract Thereafter adjusted at • Other psychotic
G1a: 14 ± 6.8
research investigator’s discretion
disorders
(n=26)†
organization weekly in increments ≤
G2: 14.3 ± 8.2
• Clinically relevant non-
Intervention 0.02 mg/kg/day up to max
neurologic disease
G2a: 13 ± 8.6†
setting:
allowable dosage of 0.06
Stereotypic
• Clinical significant
Clinic
mg/kg/day.
behavior:
laboratory abnormalities
Enrollment Duration: days (range):
G1: 7.9 ± 5.0
• Seizure disorder for
period:
G1: 52.7 (2-62)
G1a: 8.4 ± 5.8
which they were
NR
G2: 49.6 (7-63)
(n=25)†
receiving one or more
Funding: Planned: 8 weeks
G2: 8.1 ± 5.6
anticonvulsants or had a
Janssen-Ortho, Assessments:
G2a: 9.4 ± 5.5†
seizure within 3 months
Inc., Canada; CGI-S completed at
Hyperactivity/non-
Johnson & intake by investigator
• History of hypersencompliance:
Johnson ESRS, VAS-MS (most
sitivity to neuroleptics,
G1: 27.3 ± 9.7
Pharmaceutical troublesome symptom)
tardive dyskinesia,
G1a: 29.2 ± 9.5
Research and CGI-C by investigator
narcoleptic malignant
(n=25)†
Development weekly
syndrome, drug or
G2: 30.9 ± 8.8
Author industry ABC, N-CBRF (parent
alcohol abuse, or HIV
G2a: 33.6 ± 6.8
relationship version) completed
infection
(n=27)†
disclosures: weekly by parent with
• Used risperidone in the
Inappropriate
1 of 7
investigator guidance
last 3 months, previously
speech:
Janssen-Ortho (1) Groups:
unresponsive or G1: 4.6 ± 3.4
5 of 5†
G1: risperidone oral intolerant to risperidone G1a: 4.5 ± 3.7
Janssen (4) solution
• Using a prohibited (n=26)†
Janssen-Ortho (1) G2: placebo oral solution medication (including G2: 4.8 ± 3.7
Design: Ga: diagnosis of autism antipsychotics other than G2a: 4.5 ± 3.7†
RCT
Co-interventions held study medication, N-CBRF score,
stable during treatment: antidepressants, lithium, parent rated, mean
Yes
α2-antagonists, ± SD:
Frequency of contact clonidine, guanfacine, Adaptive/social:†
during study:
cholinesterase inhibitors, G1a: 3.8 ± 2.3
Weekly for 8 weeks psychostimulants, and (n=26)
Concomitant therapies: naltrexone)
G2a: 3.9 ± 2
At least one concomitant Age, years ± SD (range): Compliant/Calm:†
medication, n (%): G1: 7.6 ± 2.3 (5-12) G1a: 6.8 ± 2.7
G1: 36 (90)
G1a: 7.4 ± 2.4 (NR)† (n=25)
G2: 26 (66.7)
G2: 7.3 ± 2.3 (5-12) G2a: 6.2 ± 2.4
Medication, %:
G2a: 7.1 ± 2.1 (NR)† (n=26)
Analgesics:
G1: 37.5
G2: 17.9
change ± SD:
Irritability:
G1: -12.1 ± 5.8
G2: -6.5 ± 8.4
G1/G2: P ≤ 0.001
Lethargy:
G1: -8.6 ± 5.9
G2: -5.7 ± 6.9
G1/G2: P ≤ 0.01
Stereotypic
Behavior:
G1: -4.3 ± 3.8
G2: -2.4 ± 4.0
G1/G2: P ≤ 0.05
Hyperactivity/
noncompliance:
G1: -14.9 ± 6.7
G2: -7.4 ± 9.7
G1/G2: P ≤ 0.001
Inappropriate
speech:
G1: -2.6 ± 2.6
G2: -1.6 ± 3.0
G1/G2: P ≤ 0.05
ABC score, mean
± SD:
Irritability:†
G1a: 7.2 ± 5.9
(n=24)
G2a: 14.1 ± 11.3
G1a/G2a: P =
0.002
Lethargy:
G1a: 4.7 ± 4.4
(n=26)
G2a: 8.2 ± 8.9
G1a/G2a: P =
0.020
Stereotypic
Behavior:
G1a: 3.9 ± 4.2
(n=25)
G2a: 6.9 ± 6.9
G1a/G2a: P =
0.053
Shea et al., 2004 Cough and cold Mental age:
Conduct problem: Hyperactivity/
(continued) preparations:
IQ score, n (%):
G1: 16.8 ± 9.4 noncompliance:
G1: 25
≥ 85, normal:
G1a: 17.2 ± 8 G1a: 13.3 ± 8.7
G2: 10.3
G1: 3/31 (9.7)
(n=26)†
(n=25)
Antibiotics:
G1a: 0†
G2: 23.3 ± 12.0 G2a: 26.4 ± 12.8
C-229