title: Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders.
abstract: OBJECTIVE
  Oxytocin (OT) has been a candidate for the treatment of autism spectrum disorders (ASD), and the impact of intranasally delivered OT on ASD has been investigated. However, most previous studies were conducted by single-dose administration to adults; and, therefore, the long-term effect of nasal OT on ASD patients and its effect on children remain to be clarified.
  
  
  METHODS
  We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101). The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose). A placebo period (1-2 weeks) was inserted before each step. The outcome measures were autism diagnostic observation schedule--generic (ADOS-G), child behavior checklist (CBCL), and the aberrant behavior checklist (ABC). In addition, side effects were monitored by measuring blood pressure and examining urine and blood samples.
  
  
  RESULTS
  Six of the eight participants showed improved scores on the communication and social interaction domains of the ADOS-G. However, regarding the T-scores of the CBCL and the scores of the ABC, we could not find any statistically significant improvement, although several subcategories showed a mild tendency for improvement. Caregivers of five of the eight participants reported certain positive effects of the OT therapy, especially on the quality of reciprocal communication. All participants showed excellent compliance and no side effects.
  
  
  CONCLUSIONS
  Although our results on the efficacy of long-term nasal OT therapy still remain controversial, to the best of our knowledge, this is the first report documenting the safety of long-term nasal OT therapy for children with ASD. Even though our data are too preliminary to draw any definite conclusions about efficacy, they do suggest this therapy to be safe, promising, and worthy of a large-scale, double-blind placebo-controlled study.
authors.affiliation: Molecular Research Center for Children's Mental Development, Osaka University, Suita, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Tachibana
authors.forename: Kuriko
authors.initials: K
authors.lastname: Kagitani-Shimono
authors.forename: Ikuko
authors.initials: I
authors.lastname: Mohri
authors.forename: Tomoka
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Wakako
authors.initials: W
authors.lastname: Sanefuji
authors.forename: Ayumi
authors.initials: A
authors.lastname: Nakamura
authors.forename: Masako
authors.initials: M
authors.lastname: Oishi
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kimura
authors.forename: Tatsushi
authors.initials: T
authors.lastname: Onaka
authors.forename: Keiichi
authors.initials: K
authors.lastname: Ozono
authors.forename: Masako
authors.initials: M
authors.lastname: Taniike
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D055118:Medication Adherence; D010121:Oxytocin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010121:Oxytocin