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
Johnson and exposure to the drug. The depressants except rated, mean ± SD G2: 20.85 ± 13.01
Johnson (2) 4 pm dose could be fluoxetine and citalopram (range):†
G3: 19.27 ± 14.23
Lilly (5)
dropped by the
hydrobromide; 3 weeks Irritability:
G4: 25.09 ± 15.55
McNeil (1) prescribing clinician to for fluoxetine, citalopram 16.9 ± 10.1 (0-41) G5: 18.59 ± 12.03
Merck (1) reduce insomnia if it hydrobromide, or Lethargy/social G1/G5: P < 0.05
Novartis (2) occurred.
antipsychotics) withdrawal: G2/G5: P = NS
Pediamed (2) 3 daily doses admini- • Mental age of ≥ 18 12.1 ± 8.9 (0-33) G3/G5: P = NS
Pfizer (3) stered at 8 am, 12 pm, months as determined Stereotypy: G4/G5: P < 0.05
Shire (2) and 4 pm, respectively; by intelligence testing 7.6 ± 5.9 (0-21) Responses:
UCB (1)
Wyeth (2)
dosage (mg) by weight:
16 to < 24 kg (n=29):
Low: 2.5, 2.5, 2.5
Medium: 5.0, 5.0, 2.5
High: 10.0, 10.0, 5.0
24-34 kg (n=20):
Low: 5.0, 5.0, 2.5
Medium: 10.0, 10.0, 5.0
High: 15.0, 15.0, 10.0
• No other neuro- Hyperactivity: G1: 2.48 ± 1.45
psychiatric disorders that 33.2 ± 8.7 (2-47) G2: 1.69 ± 1.42
might require alternative Inappropriate G3: 1.93 ± 1.48
medical management speech:
G4: 2.24 ± 1.69
• For those with a tic 6.0 ± 4.1 (0-12) G5: 1.90 ± 1.71
disorder, severity had to ABC score, teacher- G1/G5: P < 0.01
be mild or less on a CGIrated, mean ± SD G2/G5: P = NS
severity subscale rating (range):†
G3/G5: P = NS
pertaining to tics only Irritability:
G4/G5: P = NS
16.1 ± 9.4 (0-43)
Posey et al., > 34 kg (n=17):
• No significant medical Lethargy/social Requesting:
2007*
Low: 5.0, 5.0, 2.5
conditions (e.g., heart or withdrawal: G1: 4.04 ± 2.25
Jahromi et al., Medium: 10.0, 10.0, 5.0 liver disease) that could 15.5 ± 10.9 (0-42) G2: 3.81 ± 2.65
2009^
High: 20.0, 20.0, 10.0 make treatment with Stereotypy: G3: 3.69 ± 3.27
(continued) Intervention, open label methylphenidate unsafe 7.6 ± 5.1 (0-19) G4: 4.13 ± 2.58
7 of 15^
Bristol-Myers
Squibb (6)
Forest (3)
Jannssen (4)
extension phase: • For those with seizure
Participants meeting the disorder, no seizures in
criteria for positive the past 6 months and
response during ≥ 1 week stable anticonvulsant
in the crossover phase dose for ≥ 1 month
Hyperactivity:
30.9 ± 7.9 (16-45)
Inappropriate
speech:
5.8 ± 3.6 (0-12)
G5: 3.67 ± 2.40
G1/G5: P = NS
G2/G5: P = NS
G3/G5: P = NS
G4/G5: P = NS
Lilly (4)
underwent best-dose • No hypertension SNAP-IV, parent- Competing
McNeil (3) determination with respect • No treatment with an rated, mean ± SD:* demands task
Neuropharm (3) to the ABC hyperactivity adequate trial of methyl- ADHD:
(n=33), mean ±
Novartis (2) subscale. If positive phenidate hydrochloride 39.82 ± 8.09 SD:
Organon (1) response during 1 week (0.4 mg/kg per dose Inattention: Self-regulating
Pfizer (1) only, that dose was given at least twice daily 20.21 ± 5.17 behavior:
Shire (3) labeled best dose; if for ≥ 2 weeks) within the Hyperactivity/ G1: 19.77 ± 10.89
Supernus (2) subject responded during past 2 years
impulsivity: G2: 16.21 ± 9.03
UCB (1)
more than 1 week of • No history of severe 19.61 ± 4.22 G3: 15.80 ± 12.65
Wyeth (1) treatment, the prescribing adverse response to Oppositional defiant G4: 16.47 ± 13.91
Design: and rating clinicians methylphenidate disorder:
G5: 12.47 ± 11.29
Randomized ranked the weeks of Exclusion criteria: 9.61 ± 6.19 G1/G5: P = 0.09
crossover trial with response in order from
• See inclusion criteria SNAP-IV, teacher- G2/G5: P < 0.01
open label best to worst, then the Age, yrs ± SD (range): rated, mean ± SD:* G3/G5: P = NS
extension phase prescribing physician
7.5 ± 2.2 (5.0-13.7)
ADHD:
G4/G5: P = 0.09
broke the blind for this Mental age, children 37.23 ± 7.04 Regulated
best dose. If this best/ completing social Inattention: affective state:
optimal dose was observation and 19.30 ± 4.32 G1: 12.91 ± 4.98
methylphenidate, the regulation substudy, Hyperactivity/ G2: 12.96 ± 3.85
participant entered the months ± SD (range): impulsivity: G3: 11.67 ± 5.53
continuation phase. 43.91 ± 19.72 (20-84) 17.93 ± 4.81 G4: 12.47 ± 4.99
Participants with no Gender, n (%):
Oppositional defiant G5: 9.57 ± 6.72
response at any week and
Male: 59 (89.4)
disorder:
G1/G5: P = NS
those responding best to
Female: 7 (10.6)
8.83 ± 5.19 G2/G5: P < 0.05
placebo exited the study. Race/ethnicity, n (%): CYBOCS-PDD, G3/G5: P < 0.05
Assessments:
White: 48 (72.7)
clinician-rated, G4/G5: P = 0.09
CGI rated by clinician at
African American: 9 (13.6) mean ± SD:* Clean-up task
each weekly visit;
Asian: 6 (9.1)
13.30 ± 3.74 (n=33), mean ±
C-52