CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Intranasal Oxytocin +1 moredrug
Likely dose
Intranasal Oxytocin 12 unitfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01337687
NCT01337687N/ACompleted

Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders

Montefiore Medical Center·interventional·Posted Apr 19, 2011·Updated Feb 27, 2020

In Brief

A clinical study evaluating Intranasal Oxytocin and Placebo for Autism Spectrum Disorders. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2011
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.2 years ago

Interventions

Intranasal Oxytocindrug

Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.

Placebodrug

Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.