The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial.
Interventions for autism are limited. The synthetic hormone oxytocin may provide a potential treatment to improve core social and behavioral difficulties in autism, but its efficacy has yet to be evaluated in young children who potentially may benefit to a greater extent. We investigated the efficacy, tolerability and safety of oxytocin treatment in young children with autism using a double-blind, randomized, placebo-controlled, crossover, clinical trial. Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment. Compared with placebo, oxytocin led to significant improvements on the primary outcome of caregiver-rated social responsiveness. Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation. This study is the first clinical trial to support the potential of oxytocin as an early intervention for young children with autism to help improve social interaction deficits.
Autism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia.
C J
CJ
Yatawara
Brain and Mind Centre, Central Clinical School, Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia.|Centre for Disability Research and Policy, Brain and Mind Centre, University of Sydney, Sydney, NSW, Australia.
S L
SL
Einfeld
Brain and Mind Centre, Central Clinical School, Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia.
I B
IB
Hickie
Brain and Mind Centre, Central Clinical School, Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia.
T A
TA
Davenport
Autism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia.
A J
AJ
Guastella
D000281:Administration, Intranasal; D000067877:Autism Spectrum Disorder / Q000188:drug therapy; D001321:Autistic Disorder / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D059085:Nasal Sprays; D010121:Oxytocin / Q000008:administration & dosage / Q000627:therapeutic use*; D012919:Social Behavior; D016896:Treatment Outcome
D059085:Nasal Sprays; D010121:Oxytocin