Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

• DOI: 10.1038/tp.2016.152
• Publication Date: 2016-08-23T13:43:31Z
• Authors: H Kosaka; Y Okamoto; T Munesue; H Yamasue; K Inohara; T Fujioka; T Anme; M Orisaka; M Ishitobi; M Jung; T X Fujisawa; S Tanaka; S Arai; M Asano; D N Saito; N Sadato; A Tomoda; M Omori; M Sato; H Okazawa; H Higashida; Y Wada
• Keywords: Oxytocin receptor

Abstract Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether dosage and genetic background receptor affects efficacy. This consisted double-blind (12 weeks), open-label weeks) follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned high-dose (32 IU per day) or low-dose intranasal (16 day), placebo groups during phase. Next, we measured single-nucleotide polymorphisms (SNPs) gene ( OXTR ). In intention-to-treat population, no outcomes improved after administration. However, male participants, Clinical Global Impression-Improvement (CGI-I) scores group, but not significantly higher than group. Furthermore, examined efficacy, reflected CGI-I scores, is influenced by estimated daily participants. found >21 day was more effective ⩽21 day, SNP (rs6791619) predicted for treatment. No severe adverse events occurred. These results suggest men ASD depends on receptor, which contributes effectiveness treatment ASD.