Clinical Trial: INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders (ASD)

Brief 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

Detailed Summary:
Sponsor: Montefiore Medical Center

Current Primary Outcome: Clinical Global Impressions Scale- Severity and Improvement [ Time Frame: Week 8 (end of study) ]

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.


Original Primary Outcome: To identify the effect of IN oxytocin (IN-OXT) vs. placebo on social function in adults with ASD. [ Time Frame: 12 weeks ]

Social function will be assessed using the Clinical Global Impressions Scale - Improvement - Social (CGI-I- Social).


Current Secondary Outcome:

  • Number of Adverse Events in Patients with Oxytocin verse Placebo [ Time Frame: Weeks 2,4, 6 and 8 ]
    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 ]
    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 ]
    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 ]
    A clinical tool measuring emotion recognition through facial expression, voice and posture. This tool is commonly used to assess nonverbal processing abilities.


Original Secondary Outcome:

  • To identify the effect of IN oxytocin (IN-OXT) vs. placebo on continuous measures of social cognition and responsiveness in adults with ASD. [ Time Frame: 12 weeks ]
    Social cognition will be assessed through the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA-2), and social responsiveness will be assessed through the Social Responsiveness Scale (SRS).
  • To determine the safety and tolerability of IN-OXT in adults with ASD. [ Time Frame: 12 weeks ]
    Safety will be assessed through the Safety Monitoring Uniform Report Form (SMURF) and Wide Range Assessment of Memory and Learning- Second Edition (WRAML-2).
  • To examine the effect of IN-OXT vs. placebo on quality of life and anxiety. [ Time Frame: 12 weeks ]
    Quality of life will be assessed through the World Health Organization Quality of Life Survey (WHOQOL-BREF) and anxiety will be assessed through the Symptom Checklist 90-Revised (SCL-90-R)


Information By: Montefiore Medical Center

Dates:
Date Received: February 7, 2013
Date Started: June 2014
Date Completion:
Last Updated: May 27, 2014
Last Verified: May 2014