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: Overall ratings:
Hollander et al., Liquid fluoxetine or • Between 5-17 years old Global Improvement CGI-AD, mean ±
2005
Country:
placebo
• Met criteria for ASD on
DSM-IV, ADI-R, &
Scale Adapted to
Global Autism
SD:
G1: RCT
US
2.5 mg/day for week 1, ADOS-G – includes (CGIAD) , mean ± Week 8: 3.58 ± 0.8
Practice
setting:
Academic
Intervention
setting:
Clinic
Enrollment
period:
NR
Funding:
FDA
NIH
Author industry
relationship
disclosures:
NR
Design:
Randomized
double-blind,
cross-over study
titrated as indicated by autism, Aspergers SD:
Crossover
subject’s symptoms and syndrome, and PDD G1: 4.5 ± 0.84 Week 20: 3.06 ± 1.1
side effects based on • Patients free of G2: 4.7 ± 0.9 G2:
weight for the next 2 psychiatric medications
RCT
weeks up to 0.8
6 weeks prior to study Educational/ Week 8: 3.42 ± 1.2
mg/kg/day (0.3 mg/kg for Exclusion criteria: cognitive/ Crossover
week 2, 0.5 mg/kg/day • Diagnosis of DSM-IV academic Week 20: 3.19 ± 1.0
for week 3, and 0.8 psychotic disorders attainment:
mg/kg/day for weeks 4–8) • History of seizures IQ, mean ±SD: CGI-AD not
• Any clinically significant
G1: 68.1 ± 26.7 significantly different
Mean maximum dose for
medical illness
G2: 59.2 ± 29.1 between
fluoxetine: 10.6 ±3.65 mg
Repetitive
• Concurrent psychotropic
intervention and
(range 4.8-20), or 0.38 ±
behavior:
medications or cognitive
placebo (P = 0.519)
0.97 mg/kg
behavioral therapy
Children’s Yale-
Brown Obsessive- Global Composite
• Individuals who were
Mean final dose for
Compulsion Scale, Improvement
responding well to
fluoxetine: 9.9 mg ± 4.35
compulsions (reported at weeks 8
previous interventions or
(range 2.4-20 mg), or 0.36
subscale (CY- and 20), mean ±
had only mild global
± 0.116 mg/kg.
BOCS), mean ± SD: SD:
severity
G1: 13.5 ± 2.9 G1: RCT
• Subjects unable to
3 treatment phases:
G2: 12.8 ± 2.6 Week 8: 3.21 ± 2.6
tolerate a minimum dose
8 week randomized
Crossover
of 2.4 mg/day of liquid
control trial
Adaptive behavior: Week 20: 1.73 ± 3.6
fluoxetine
4 week wash out period
Vineland adaptive G2:
Age, mean/yrs ±SD
8 week cross over study
behavior composite, RCT
(range): 8.18 ± 3.04 (5-16)
mean ± SD: Week 8: 2.21 ± 3.0
Mental age, mean/yrs
Assessments: Clinical
G1: 47.9 ± 19.4 Crossover
(range): NR
Global Improvement
G2: 45.1 ± 24.6 Week 20: 3.50 ± 3.0
Gender:
Scale Adapted to Autism,
M, n (%): 30 (76.9)
Children’s Yale-Brown
Global Comp
F, n (%): 9 (23.1)
Obsessive –Compulsion
improvement
Scale, Global Autism
trending toward
Composite Improvement ,
significance ( P =
Overt Aggression Scale
0.056)
Hollander et al.,
2005 (continued)
Subjects monitored and
assessed weekly by the
treating physician, who
was blind to treatment
condition, during the first
4 weeks of each
fluoxetine/placebo phase
of the study. For the
remainder of the trial, and
during the washout
period, patients were
monitored every other
week.
Adverse effects monitored
via the clinician
Race/ethnicity, n (%):
Caucasian 22 (56.4)
Asian 2 (5.1)
Black 9 (23.1)
Hispanic 6 (15.4)
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
In Study
Diagnostic tool/method:
DSM-IV TR diagnosis by
C-304
Repetitive
behavior:
CY-BOCS, mean ±
SD:
G1: RCT
Week 0: 13.45 ± 2.9
Week 4: 12.7 ± 3.2
Week 8: 12.95 ± 3.2
Crossover
Week 12: 12.93 ±
3.5
Week 16: 11.94 ±
3.4
Week 20: 11.77 ±
3.2
G2: RCT
Week 0: 12.84 ± 2.6