Nasal oxytocin in children and adolescents with autism spectrum disorders.

NEngl J Med 2021; 385: 1462-1473

DOI: 10.1056 / NEJMoa2103583

Commentary

This study was a 24-week, placebo-controlled, phase II trial of nasal oxytocin therapy in children and adolescents aged 3-17 years with autism spectrum disorders.

Participants were randomly assigned in a 1:1 ratio, stratified according to age and language fluency, and received either intranasal oxytocin or placebo, with a total target dose of 48 international units per day.

The primary outcome was the least-squares mean change from baseline on the 13-item Abnormal Behavior Checklist-modified Social Withdrawal Subscale (ABC-mSW).

As a result, 290 of 355 screened children and adolescents were enrolled, with a total of 146 participants assigned to the oxytocin group and 144 assigned to the placebo group.

One hundred and thirty-nine and 138 participants, respectively, completed both baseline and at least one post-baseline ABC-mSW assessment and were included in the modified intention-to-treat analysis.

The least squares mean change from baseline in ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group.

Secondary outcomes generally did not differ between the study groups, and the incidence and severity of adverse events were similar in the two groups.