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Therapies for Children With Autism Spectrum Disorders

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Evidence Table. <strong>Therapies</strong> <strong>for</strong> children with ASD (continued)<br />

Study<br />

Description Intervention<br />

Kim et al., 2008*<br />

Kim et al., 2009†<br />

(continued)<br />

Author:<br />

King et al.,<br />

2009<br />

Country:<br />

US<br />

Practice<br />

setting:<br />

Academic<br />

Intervention<br />

setting:<br />

Academic<br />

Enrollment<br />

period:<br />

NR<br />

Funding:<br />

NIH<br />

Author industry<br />

relationship<br />

disclosures:<br />

8 of 13<br />

Abbot Labs (3)<br />

Aspect Medical<br />

Intervention:<br />

Citalopram 10 mg/5 mL or<br />

placebo<br />

Dosing: children < 40 kg:<br />

2.5 mg/day increased by<br />

2.5 mg increments until<br />

day 43, then increased biweekly<br />

in 5 mg increments,<br />

up to 20 mg/day<br />

<strong>Children</strong> ≥ 40 kg: 2.5 mg<br />

dosage increased in<br />

weekly intervals until day<br />

36, then increased by<br />

5 mg biweekly up to 20<br />

mg/day; if treating<br />

clinician suspected a<br />

dose-limiting adverse<br />

effect, the dosage could<br />

be lowered in 2.5 mg<br />

increments<br />

Assessments:<br />

Two masked clinicians<br />

Inclusion/ Exclusion<br />

Criteria/ Population<br />

Inclusion criteria:<br />

• 5 to 17 years old<br />

• Met DSM-IV_TR criteria<br />

<strong>for</strong> autistic disorder,<br />

Asperger disorder or<br />

PDD-NOS<br />

• CGI-S illness severity<br />

rating at least moderate<br />

• Compulsive behaviors<br />

score at least moderate<br />

on CYBOCS-PDD<br />

Exclusion criteria:<br />

• Rhett disorder<br />

• Child disintegrative<br />

disorder<br />

• Seizure within past 6<br />

months<br />

• Weight less than 15 kg<br />

• Medical condition that<br />

might interfere with study<br />

participation<br />

• Clinically significant<br />

C-61<br />

Baseline<br />

Measures Outcomes<br />

selected sessions<br />

(P < 0.001) and<br />

undirected and<br />

directed parts<br />

(P < 0.001)<br />

Problem<br />

behavior:†<br />

Compliant<br />

response,<br />

frequency, mean<br />

± SD:<br />

G1: 4.61 ± 3.22<br />

G2: 4.16 ± 4.00<br />

G1/G2: P < 0.001<br />

ANOVA:<br />

Significant difference<br />

between<br />

selected sessions<br />

(P < 0.05)<br />

No response,<br />

frequency, mean<br />

± SD:<br />

G1: 1.43 ± 1.79<br />

G2: 3.04 ± 2.68<br />

G1/G2: P < 0.001<br />

Harms:<br />

NR<br />

Modifiers:<br />

None of the tested<br />

two- and threeway<br />

interactions<br />

of the predictors<br />

were significant<br />

<strong>for</strong> any of the<br />

outcomes.<br />

Overall ratings:<br />

CGI-I score, n (%):<br />

4:<br />

G1: 21 (28.8)<br />

G2: 22 (28.8)<br />

5:<br />

G1: 37 (50.7)<br />

G2: 37 (48.7)<br />

6:<br />

G1: 14 (19.2)<br />

G2: 16 (21.1)<br />

7:<br />

G1: 1 (1.4)<br />

G2: 1 (1.3)<br />

Social skills:<br />

ABC-C social<br />

withdrawal subscale,<br />

mean ± SD:<br />

G1: 11.4 ± 8.2<br />

G2: 11.1 ± 8.0<br />

Communication/<br />

language:<br />

Overall ratings:<br />

CGI-I score, 12<br />

weeks, mean:<br />

G1: NR*<br />

G2: NR*<br />

G1+G2/BL: P <<br />

0.001<br />

G1/G2: P = NS<br />

Positive response,<br />

12 weeks, %:<br />

CGI-I criteria:<br />

G1: 32.9<br />

G2: 34.2<br />

G1/G2: P = NS<br />

CYBOCS-PPD<br />

and CGI-I criteria:<br />

G1: 20.6<br />

G2: 13.2<br />

G1/G2: P = NS<br />

Social skills:<br />

ABC-C social<br />

withdrawal

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