Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Description Intervention
Author:
Owley et al., 2010
Country:
US
Practice
setting:
Academic clinic
Intervention
setting:
Academic medical
center
Enrollment
period:
NR
Funding:
NIH, Autism
Speaks
Author industry
relationship
disclosures:
NR
Design:
Prospective case
series
Intervention:
10-week open label study
of escitalopram based on
genotype group, with
participants seen at clinic
at study start (baseline),
week 4, and week 10.
Forced titration with
weekly increasing doses
of escitalopram (2.5, 5,
10, 15, 20mg) unless
specific criteria for
downward titration due to
side effects were met.
Assessments:
ABC-C completed weekly
by parents/caregivers
Groups:
G1: all participants
G1a: Low expression of
serotonin transporter
polymorphism promoter
region (5-HTTPLR)
genotypic variation (9
S/S)
G1b: Intermediate
expression (1 LG/LG, 2
S/LG, 2 LA/LG, 24 S/L)
G1c: High expression (19
LA/LA)
Co-interventions held
stable during treatment:
NR
Frequency of contact
during study:
Inclusion/ Exclusion
Criteria/ Population
Inclusion criteria:
• Diagnosis of an ASD
• Minimum score of 12 on
the ABC-CV
Exclusion criteria:
• Parental sleep diaries
during pre-medication
baseline week indicating
a range in time of
awakening greater than
2 hours over 7 days
• Concomitant serious
medical or psychiatric
conditions, including
seizures
• Study personnel unable
to obtain blood sample
due to child’s
restlessness (n=1)
• Dropout (n=1)
Age, mean months ± SD
(range):
G1: 117 ± 31 (54-204)
G1a: 124 ± 22 (98–164)
G1b: 121 ± 34 (82–204)
G1c: 106 ± 28 (54–160)
Mental age:
NR
Gender, n (%):
G1:
M: 48 (83)
F: 10 (17)
G1a:
M: 8 (89)
F: 1 (11)
G1b:
M: 25 (86)
C-18
Baseline
Measures Outcomes
and school
environment
issues on followup)
ADI-R, mean ± SD
(range):
G1:
Social interaction:
23 ± 5 (11-30)
Communication,
verbal: 17 ± 4 (7-26)
Communication,
non-verbal: 13 ± 2
(10-15)
Repetitive behavior:
6 ± 3 (1-15)
Abnormality of
development: 4 ± 1
(1-5)
G1a:
Social interaction:
24 ± 4 (18-29)
Communication,
verbal: 18 ± 5 (11-
26)
Communication,
non-verbal: 13 ± 1
(13-14)
Repetitive behavior:
6 ± 2 (2-9)
Abnormality of
development: 4 ± 1
(2-5)
G1b:
Social interaction:
24 ± 4 (14-30)
Communication,
verbal: 17 ± 4 (10-
23)
Communication,
non-verbal: 12 ± 2
(10-15)
Repetitive behavior:
7 ± 3 (2-12)
Modifiers
No significant
effect of Use of
alternative
therapies,
multivitamins,
prescription
medication or
special diets on
enzyme effect
size in GEE
model
Problem
behavior:
Final data on ABC
Irritability
subscale scores
only represented
graphically.
Harms
NR
Modifiers
Final dose did not
differ significantly
between genotype
groups.
Age and weight
were not
significantly
correlated with
final dose in the
whole group or in
the genotype
expression
subgroups.