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.
RCT Entities:
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 ASDpatients 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: Erwin H van den Burg; Benjamin Jurek; Inga D Neumann; Julia Winter; Magdalena Meyer; Ilona Berger; Melanie Royer; Marta Bianchi; Kerstin Kuffner; Sebastian Peters; Simone Stang; Dominik Langgartner; Finn Hartmann; Anna K Schmidtner; Stefan O Reber; Oliver J Bosch; Anna Bludau; David A Slattery Journal: Mol Psychiatry Date: 2021-05-25 Impact factor: 15.992
Authors: Jacob A S Vorstman; Will Spooren; Antonio M Persico; David A Collier; Stefan Aigner; Ravi Jagasia; Jeffrey C Glennon; Jan K Buitelaar Journal: Psychopharmacology (Berl) Date: 2013-11-30 Impact factor: 4.530
Authors: Pamela Ventola; Hannah E Friedman; Laura C Anderson; Julie M Wolf; Devon Oosting; Jennifer Foss-Feig; Nicole McDonald; Fred Volkmar; Kevin A Pelphrey Journal: J Autism Dev Disord Date: 2014-11
Authors: Elizabeth A Simpson; Valentina Sclafani; Annika Paukner; Amanda F Hamel; Melinda A Novak; Jerrold S Meyer; Stephen J Suomi; Pier Francesco Ferrari Journal: Proc Natl Acad Sci U S A Date: 2014-04-28 Impact factor: 11.205