Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial

Abstract

BackgroundThere are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.MethodsThis was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale – compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire – emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses.ResultsAlthough no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire – emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported.ConclusionsThis pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted.Trial registrationNCT00490802

Oxytocin enhances brain function in children with autism

“…Behavioral improvements may require richer, more realistic social contexts that include opportunities for social learning (4). For example, only modest improvements in social functioning were observed in adults with ASD who were treated daily, for 6 wk, with administration of intranasal OT (14). Similarly, no changes in social behavior were found when OT was given once every morning for 5 d to children with ASD, even in a context of behavioral treatment (15).…”

“…Furthermore, although there are several large-scale clinical trials currently underway (www. clinicaltrials.gov) to examine the effects of chronically administered OT in ASD, the empirical record shows that behavioral effects have been mixed at best (13)(14)(15). For example, two recent studies of the effects of repeated daily administration for a period of weeks have resulted in only modest improvements in social behavior (14,15).…”

“…clinicaltrials.gov) to examine the effects of chronically administered OT in ASD, the empirical record shows that behavioral effects have been mixed at best (13)(14)(15). For example, two recent studies of the effects of repeated daily administration for a period of weeks have resulted in only modest improvements in social behavior (14,15). The rapid movement from single administration studies in healthy adults and individuals with ASD to chronic administration to individuals with ASD has introduced a "translational hurdle" (13,16), one that we aimed to tackle by exploring the neural basis of OT's effects.…”

Plasma oxytocin levels are reduced in Slovak autistic boys

“…polymorphisms in the oxytocin receptor gene and/or altered plasma oxytocin levels (7,20). Moreover, these social defi cits seem to be at least partially improved after oxytocin administration in autistic patients (10,(13)(14)(15). A limitation of the present study is an absence of behavioural data in autistic patients.…”

“…Intranasal and intravenous oxytocin administration was shown to improve some of the clinical symptoms of autism, such as repetitive behaviours (12), increased social learning (13), increased social recognition and emotionality (14,15), and improved social interaction in high functioning autistic patients (10).…”