Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Inclusion/ Exclusion Baseline
Description Intervention
Criteria/ Population Measures Outcomes
2009
week 1, increased to 5 diagnosis (DSMIV, ADI- mean (SE): LOCF, mean
Country: mg/day for week 2 and R) and demonstrated G1a: 5.0 (0.1) change (SE):
US
increased in 5 mg
tantrums, aggression, (n=44)
G1a: -0.9 (0.2)
Practice increments until assigned self-injurious behavior, G1b: 4.9 (0.1) (n=44)
setting:
daily dose (5, 10, 15 or combination (n=52)
G1b: -1.0 (0.1)
Pharmaceutical mg/day) reached • CGI-S score ≥ 4 at G1c: 5.1 (0.1) (n=52)
company Assessments:
screening and baseline (n=44)
G1c: -1.1 (0.2)
Intervention ABC rated by caregiver at • ABC irritability score G2: 4.7 (0.1) (n=44)
setting:
each visit; CGI-severity ≥ 18 at screening and (n=41)
G2: -0.6 (0.2)
Multi-site clinics and improvement rated by baseline
Social skills: (n=41)
Enrollment clinician at each visit, Yale • Weight ≥ 15 kg ABC lethargy/social G1a/G2: P = NS
period:
Brown Obsessive Com- • Age 6-17 yrs
withdrawal score, G1b/G2: P ≤ 0.05
June 2006 to June pulsion Scale (compulsion Exclusion criteria: LOCF, mean (SE): G1c/G2: P = ≤
2008
scale only, weeks 0,4,8), Current diagnosis of G1a: 17.7 (1.4) 0.05
Funding: administrator/rater NR; bipolar disorder, (n=52)
Response rate,
Bristol Myers Pediatric QoL Inventory, psychosis,
G1b: 16.8 (1.3) week 8, n (%)
Sqibb, Otsuka Caregiver Strain
schizophrenia, major (n=59)
G1a: 29 (55.8)
Pharmaceutical Questionnaire assessed depression, or fragile X G1c: 18.9 (1.4) (n=52; P ≤ 0.05)
Co.
at baseline and week 8. syndrome
(n=53)
G1b: 29 (49.2)
Author industry Simpson-Angus Scale, • Diagnosis of another G2: 18.0 (1.5) (n=59; P = NS)
relationship Barnes Akathisia Rating disorder on the autism (n=49)
G1c: 28 (52.8)
disclosures: Scale, Abnormal
spectrum including PDD- Repetitive (n=53; P = NS)
5 of 7
Involuntary Movement NOS, Asperger behavior:
G2:17 (34.7)
Bristol-Myers Scale used by clinician to syndrome, Rett ABC stereotypy (n=49; P = NS)
Squibb (5) rate adverse events syndrome, or childhood score, LOCF, mean Social skills:
Forest (1) Groups:
disintegrative disorder (SE):
ABC lethargy/
Johnson & G1a: aripiprazole 5
• History of neuroleptic
G1a: 11.4 (0.8) social withdrawal
Johnson (1) mg/day
malignant syndrome
(n=52)
score, week 8,
Otsuka (2) G1b: aripiprazole 10
• Significant risk for
G1b: 11.6 (0.8) LOCF, mean
Design: mg/day
suicide
(N=59)
change (SE):
RCT, multicenter G1c: aripiprazole 15
G1c: 11.6 (0.8) G1a: -5.8 (1.2)
• Seizure in past year
study
mg/day
(n=53)
(n=52)
• History of severe head
Note:
G2: placebo
G2: 10.7 (0.8) G1b: -4.9 (1.1)
trauma or stroke
See related study Co-interventions held
(n=49)
(n=59)
Owen et al. 2009 stable during treatment:
• History or evidence of
Problem behavior: G1c: -7.9 (1.1)
({#5714}) All psychotropic
unstable medical
ABC hyperactivity (n=53)
medications discontinued
conditions
score, LOCF, mean G2: -5.2 (1.2)
prior to study; sleep aids, • Clinically significant lab (SE):
(n=49)
anti-anxiety medication
or diagnostic test result G1a: 33.1 (1.4) G1a/G2: P = NS
diphenhydramine, • Demonstrated resistance (n=52)
G1b/G2: P = NS
psychotropic medications to antipsychotic G1b: 33.7 (1.3) G1c/G2: P = NS
for acute treatment of medication or allergy/ (n=59)
unforeseen events, hypersensitivity to G1c: 32.2 (1.4)
benztropine, propranolol aripiprazole
(n=53)
administered at
• Unstable/inconsistent G2: 31.0 (1.4)
investigators discretion non-pharmacologic (n=49)
Frequency of contact therapies
during study:
Age, years ± SD:
Weekly clinic visits; tele- G1a: 9.0 ± 2.8
phone contact at week 7 G1b: 10.0 ± 3.2
G1c: 9.5 ± 3.1
G2: 10.2 ± 3.1
Marcus et al., Concomitant therapies, Mental age:
Communication/ Communication/
2009
%:
NR
language: language:
(continued) Analgesics and
Gender, n (%):
ABC inappropriate ABC inappropriate
antipyretics:
Male:
speech score, speech score,
G1a: 23.1
G1a: 47 (88.7)
LOCF, mean (SE): week 8, LOCF,
G1b: 30.2
G1b: 50 (84.7)
G1a: 5.8 (0.6) mean (SE):
C-68