Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders (INOT)
|ClinicalTrials.gov Identifier: NCT01337687|
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: Intranasal Oxytocin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Drug: Intranasal Oxytocin
Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
|Placebo Comparator: Placebo||
Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
- Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: 6 Weeks ]Rating Scale that utilizes direct observation, scales and patient report to inform clinical judgment. A form of CGI that targets social functioning will be used as the primary outcome measure. Semi-structured interview.
- Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Baseline, Week 6 ]
Clinician-Rated questionnaire measuring the time spent, distress,interference, resistance, and control in relation to obsessions and compulsions based on a 5 point scale ranging from 0-5 for each category with 0 being most desirable and 5 being least. Sub-scales are added and averaged to obtain total scores.
-scale range (total): 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme
Questions are rated on a 5-point scale, 0-4, increasing in severity. Obsession Rating Subscale (5 questions, ranging from 0 - 20 total) and Compulsion Rating subscale (5 questions, ranging from 0 - 20 total) are totaled and added to obtain total scores.
-score interpretation: Higher overall scores reflect increasing symptom severity.
- Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R) [ Time Frame: Baseline, week 6 ]
Subscale ranges: stereotypic behavior (0 - 27);self-injurious behavior (0 - 24); compulsive behavior (0 - 18); ritualistic/Sameness Behavior (0 - 36); restricted Interests (0 - 9).
Higher score in all subscales reflect increasing severity. Questions rate behaviors on a 4-point scale: 0 = does not occur; 1 = occurs, mild problem; 2 = occurs, moderate problem; 3 = occurs, severe problem. Subscale scores consist of sum of ratings within each question subset.
Lower order behaviors-- stereotypy and self-injury, higher order behaviors--compulsions, rituals /sameness, restricted interests.
Lower Order total range: 0-51, Higher Order total range: 0-63 Stereotypic behavior and Self-injurious behavior subscales were summed to create a total range for Lower Order behavior; and Compulsive behavior, ritualistic /sameness behavior, and restricted interests subscales were summed to create a total range for Higher Order behavior.
- Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2) [ Time Frame: baseline, week 6 ]
A clinical tool measuring emotion recognition through facial expression, voice and posture.
- Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)
- Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)
- Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)
- Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337687
|United States, New York|
|Montefiore Medical Center, Albert Einstein College of Medicine|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Eric Hollander, MD||Montefiore Medical Center/Albert Einstein College of Medicine|