The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial.

Researchers tested whether oxytocin nasal spray could help improve social skills in 87 children with autism aged 3-12 years. Children received either oxytocin or a fake treatment for 12 weeks. Overall, oxytocin didn't work better than the fake treatment. However, younger children (ages 3-5) showed some improvement in social responsiveness according to their parents.

The treatment was safe with few side effects. More research is needed to understand if oxytocin might help younger children with autism.

This randomized controlled trial examined intranasal oxytocin's effects on social interaction in 87 children with autism aged 3-12 years. Participants received either oxytocin (16 IU twice daily) or placebo for 12 weeks following a 3-week placebo lead-in phase. Overall, oxytocin showed no significant effect on the primary outcome (Social Responsiveness Scale). However, an age interaction analysis revealed potential benefits for younger children (3-5 years) on caregiver-rated social responsiveness.

No benefits were observed on clinician-rated measures or secondary outcomes. Oxytocin was well-tolerated with fewer adverse effects than placebo. The study highlights the importance of considering age in autism intervention research.

Results suggest oxytocin may not be effective as a general autism intervention but warrant further investigation in younger children. The age-dependent response highlights the importance of developmental timing in autism research and treatment approaches.

Single primary outcome measure; benefits only observed on caregiver ratings, not clinician assessments; significant placebo effects noted during lead-in phase; relatively small subgroup analysis for younger children may limit generalizability of age-specific findings.

Early supports to enhance social development in children with autism are widely promoted. While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development in humans remains unclear. We investigated the efficacy, tolerability, and safety of intranasal oxytocin in young children with autism using a double-blind, randomized, placebo-controlled, clinical trial, following a placebo lead-in phase. A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase.

Overall, there was no effect of oxytocin treatment over time on the caregiver-rated Social Responsiveness Scale (SRS-2) (p = 0.686). However, a significant interaction with age (p = 0.028) showed that for younger children, aged 3-5 years, there was some indication of a treatment effect. Younger children who received oxytocin showed improvement on caregiver-rated social responsiveness ( SRS-2). There was no other evidence of benefit in the sample as a whole, or in the younger age group, on the clinician-rated Clinical Global Improvement Scale (CGI-S), or any secondary measure.

Importantly, placebo effects in the lead-in phase were evident and there was support for washout of the placebo response in the randomised phase. Oxytocin was well tolerated, with more adverse side effects reported in the placebo group. This study suggests the need for further clinical trials to test the benefits of oxytocin treatment in younger populations with autism.Trial registration www.anzctr.org.au (ACTRN12617000441314).