Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders (INOT)
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders|
- Clinical Global Impressions Scale- Severity and Improvement [ Time Frame: Week 8 (end of study) ] [ Designated as safety issue: No ]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.
- Number of Adverse Events in Patients with Oxytocin verse Placebo [ Time Frame: Weeks 2,4, 6 and 8 ] [ Designated as safety issue: Yes ]Adverse events will be recorded for each subject by the study psychiatrist at the study visit in weeks 2 -8. Although no formal statistical analyses will be completed, results from Intranasal Oxytocin groups will be compared to the placebo group.
- Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: baseline, weeks 2,4,6,8 ] [ Designated as safety issue: No ]Clinician-Rated questionnaire measuring the time spent, distress,interference, resistance, and control in relation to obsessions and compulsions based on a 5 point scale.
- Repetitive Behavior Scale - Revised (RBS-R) [ Time Frame: Baseline, weeks 2,4,6,8 ] [ Designated as safety issue: No ]A clinical tool measuring repetitive behaviors specific to Autism Spectrum Disorder (ASD).
- Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2) [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]A clinical tool measuring emotion recognition through facial expression, voice and posture. This tool is commonly used to assess nonverbal processing abilities.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
|Contact: Casara J Ferretti, MSfirstname.lastname@example.org|
|Contact: Emma Racine||718-653-4859 ext email@example.com|
|United States, New York|
|Montefiore Medical Center, Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Casara J Ferretti, MS 718-696-3036 firstname.lastname@example.org|
|Principal Investigator: Eric Hollander, MD|
|Principal Investigator:||Eric Hollander, MD||Montefiore Medical Center, Albert Einstein College of Medicine|