Sikich L, Kolevzon A, King BH, et al. - Intranasal oxytocin therapy for autism spectrum disorder was tested in this placebo-controlled trial, findings revealed no significant between-group differences in the least-squares mean alteration from baseline on measures of social or cognitive functioning over a period of 24 weeks.

• As per experimental studies and small clinical trials, intranasal oxytocin therapy may decrease social impairment in patients with autism spectrum disorder.

• This is a 24-week, placebo-controlled phase 2 trial including children and adolescents (n=290, 3 to 17 years of age) with autism spectrum disorder, randomized to oxytocin or placebo, delivered intranasally, with a total target dose of 48 international units daily.

• The primary outcome [least-squares mean change from baseline in the ABC-mSW (Aberrant Behavior Checklist modified Social Withdrawal subscale) score] was −3.7 and −3.5 in the oxytocin and placebo groups, respectively (least-squares mean difference, −0.2).

• Generally, no difference in secondary outcomes (two additional measures of social function and an abbreviated measure of IQ) was seen between the trial groups.

• Regarding adverse events, incidence and severity were similar in the two groups.