A randomized placebo-controlled pilot trial shows that intranasal vasopressin improves social deficits in children with autism
| Autor: | Kara S. Motonaga, Robin A. Libove, Debra S. Karhson, Karen J. Parker, Jacqueline E. Summers, Noreen Mohsin, Lawrence K. Fung, Joseph P. Garner, Kyle Hinman, Jennifer M. Phillips, Ozge Oztan, Dean S. Carson, Antonio Y. Hardan, Raena D. Sumiyoshi |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Vasopressin business.industry General Medicine medicine.disease Placebo law.invention Clinical trial 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Tolerability Randomized controlled trial law Internal medicine medicine Autism Anxiety medicine.symptom business hormones hormone substitutes and hormone antagonists 030217 neurology & neurosurgery Social behavior |
| Zdroj: | Science Translational Medicine. 11 |
| ISSN: | 1946-6242 1946-6234 |
| Popis: | The social impairments of autism spectrum disorder (ASD) have a major impact on quality of life, yet there are no medications that effectively treat these core social behavior deficits. Preclinical research suggests that arginine vasopressin (AVP), a neuropeptide involved in promoting mammalian social behaviors, may be a possible treatment for ASD. Using a double-blind, randomized, placebo-controlled, parallel study design, we tested the efficacy and tolerability of a 4-week intranasal AVP daily treatment in 30 children with ASD. AVP-treated participants aged 6 to 9.5 years received the maximum daily target dose of 24 International Units (IU); participants aged 9.6 to 12.9 years received the maximum daily target dose of 32 IU. Intranasal AVP treatment compared to placebo enhanced social abilities as assessed by change from baseline in this phase 2 trial’s primary outcome measure, the Social Responsiveness Scale, 2nd Edition total score (SRS-2 T score; F1,20 = 9.853; P = 0.0052; ηp2 = 33.0%; Cohen’s d = 1.40). AVP treatment also diminished anxiety symptoms and some repetitive behaviors. Most of these findings were more pronounced when we accounted for pretreatment AVP concentrations in blood. AVP was well tolerated with minimal side effects. No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions. Last, no changes from baseline were observed in vital signs, electrocardiogram tracings, height and body weight, or clinical chemistry measurements after 4 weeks of AVP treatment. These preliminary findings suggest that AVP has potential for treating social impairments in children with ASD. |
| Databáze: | OpenAIRE |
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