Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD
Study
Inclusion/Exclusion Baseline
Description Intervention
Criteria/Population Measures Outcomes
administered FSEC at psychiatric interview, ADI-
Week 4: 11.05 ± 3.4
every visit. CY-BOCS and R, ADOS-G, VABS,
Week 8: 11.63 ± 3.8
CGI-AD outcome WPPSI-R, WISC-III, WAIS-
Crossover
assessments completed III, LIPS-R
Week 12: 12.24
by blinded independent
±3.5
evaluator at baseline and Diagnostic category, n
Week 16: 12.13 ±
every 4 weeks, until week (%):
2.6
20 or termination. G1:
Week 20: 12.38 ±
Autism: 17 (85)
2.4
Fluoxetine Side Effects Aspergers: 3 (15)
Checklist completed by G2:
Fluoxetine superior
parent with psychiatrist, if Autism: 17 (89.5)
to placebo on CYable
to do so, at each
visit.
Aspergers: 2 (10.5)
BOCS (P = 0.038)
Problem behavior:
Groups:
Other characteristics, n
OAS-M: no trend or
G1: placebo (RCT)/liquid (%):
significant effect of
fluoxetine (crossover) Mentally retarded: 23 (59)
drug vs placebo on
G2: liquid fluoxetine
the suicide subscale
(RCT)/placebo
Fluoxetine: 0
(crossover)
Placebo: 1
Hollander et al.,
2005 (continued)
Co-interventions held
stable during treatment:
Yes
Frequency of contact
during study:
Weekly during first 4
weeks of each
fluoxetine/placebo phase
of the study; every other
week during the
remainder of the trial and
the washout period
Concomitant therapies,
n (%):
No concurrent
psychotropic medications
or cognitive behavioral
therapies were allowed
during the study
N at enrollment: 45
(G1 and G2 n’s NR)
N continuing after
randomization:
G1: 20
G2: 19
N at follow-up:
G1: 18
G2: 16
C-305
Harms, n/N (%):
Insomnia:
Fluoxetine: 14/39
(35.9)
Placebo: 17/36
(47.2)
Anxiety/nervousnes
s:
Fluoxetine: 6/39
(15.9)
Placebo: 12/36
(33.3)
Urinary
incontinence:
Fluoxetine: 4/39
(10.3)
Placebo: 7/36 (19.4)
Drowsiness/fatigue/
sedation:
Fluoxetine: 7/39
(17.9)
Placebo: 4/36 (11.1)
Agitation:
Fluoxetine: 18/39
(46.2)
Placebo: 16/36
(44.4 )
Diarrhea:
Fluoxetine: 2/39
(5.1)
Placebo: 7/36 (19.4)