Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in
speech and communication, impaired social functioning and repetitive behaviors and restricted
interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating
uterine contractions and milk let-down; however, studies, mainly with rodents and non-human
primates, has found that OT is involved in affiliative behaviors, including sexual behavior,
mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of
social attachment. Moreover, OT is known to play an important role in repetitive behaviors
and stress reactivity. Given that repetitive behaviors and deficits in social interaction are
core symptom domains of autism, and that OT is involved in the regulation of repetitive and
affiliative behaviors, it is believed that OT may play a role in the etiology of autism.
Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of
value in treating core autism symptoms. Specifically, synthetic oxytocin administered via
intravenous infusion to adults with autism spectrum disorders (ASD) produced significant
reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind,
placebo-controlled cross-over laboratory challenge.
Encouraged by these findings, the primary aim of this study is to investigate the safety and
therapeutic efficacy of intranasal OT in treating repetitive behaviors and social
functioning/cognitive deficits in adults with ASD. This research embraces a translational
approach to develop a novel treatment for core ASD symptoms; given that there are currently
no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,
this research addresses an important unmet need in the field. The goal of this study is to
evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment
(INOT)administration in adults with ASD.
Phase:
N/A
Details
Lead Sponsor:
Montefiore Medical Center
Collaborator:
National Alliance for Research on Schizophrenia and Depression