25418
A Randomized Controlled Trial of Intranasal Oxytocin in Autism Spectrum Disorder

Thursday, May 11, 2017: 2:52 PM
Yerba Buena 3-6 (Marriott Marquis Hotel)
E. Anagnostou1,2, J. A. Brian1,3, C. Campo-Soria4, L. Capano1,5, A. N. Esler4, R. Hudock4, D. Mankad1,2, M. Penner1,2, S. M. Francis6, L. Genore2, A. Iaboni2, D. Odrobina2, N. Peleg2, D. Rambeck4, E. L. Shankland4, A. Dupuis1,7 and S. Jacob4, (1)University of Toronto, Toronto, ON, Canada, (2)Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON, Canada, (3)Bloorview Research Institute, Toronto, ON, Canada, (4)University of Minnesota, Minneapolis, MN, (5)Autism Research Centre, Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON, Canada, (6)Department of Psychiatry, University of Minnesota, Minneapolis, MN, (7)The Hospital for Sick Children, Toronto, ON, Canada
Background: There are currently no medications with evidence supporting their use to treat the core symptoms of the disorder. Convergent evidence, however, suggests a role for oxytocin in social cognition and reward.

Objectives: The primary aim of this study was to investigate the safety and efficacy of intranasal oxytocin in treating social withdrawal in autism spectrum disorder (ASD). The effect of oxytocin on social cognition as well as anxiety was also examined.

Methods: 60 children and adolescents (mean age: 12.4 ± 1.8 years) participated in a 12 week, randomized, double-blind, placebo-controlled trial of oxytocin, at 0.4 IU/kg twice a day. The primary outcome measure was the Aberrant Behavior Scale – Social Withdrawal subscale [ABC-SW] score). Adverse effects were also assessed every two weeks using the Safety Monitoring Uniform Research Form (SMURF). Aspects of social cognition as well as anxiety and quality of life were also evaluated.

Results: 54 patients completed the trial. 6 patients withdrew from the trial (5 active, 1 placebo), 1 due to adverse events and 5 due to the withdrawal of consent. Oxytocin was overall well tolerated, with no serious adverse drug reactions reported. There were no significant differences between participants on placebo and those on oxytocin on social withdrawal (ABC-SW: p=0.6). However, participants taking oxytocin did have a significant improvement in social recognition as measured by the Let’s Face It! Battery (p=0.02). This was not seen in the case of object recognition as measured by the same battery (p=0.4) suggesting a specific social recognition effect.

Conclusions: In our sample, oxytocin was not superior to placebo in terms of reduction in social withdrawal. However, participants taking oxytocin did show a significant improvement in social recognition, suggesting that oxytocin may impact aspects of social cognition but may not be adequate to improve social function on its own. Implications for combination trials will be discussed.

See more of: New Directions in the Pharmacological Treatment of Social Disability in ASD
See more of: Interventions - Pharmacologic