Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders (INOT)

This study is currently recruiting participants.
Verified May 2013 by Montefiore Medical Center
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01337687
First received: December 15, 2010
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Autism Spectrum Disorders
Drug: Intranasal Oxytocin
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 34
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)
Arms Assigned Interventions
Experimental: Oxytocin 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 Drug: Placebo
Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female
  • 18 to 55 years old
  • Meet DSM-IV, ADOS, and ADI-R standards for Autism Spectrum Disorder or Aspergers Syndrome
  • Have a high, normal or near normal IQ
  • Speak and Understand English fluently

Exclusion Criteria:

  • Born prior to 35 weeks gestational age
  • Any primary psychiatric diagnosis other than autism at the time of screening
  • Medical history of neurological disease
  • Medical history of known MRI/structural lesion of the brain
  • Patients who are pregnant
  • With a medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well being
  • With evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic or gastrointestinal disease
  • Taking psychoactive medications
  • Who plan to initiate or change nonpharmacologic interventions during the study course
  • Who are unable to tolerate venipuncture procedures for blood sampling
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337687

Contacts
Contact: Casara J Ferretti, MS 7186963036 cferrett@montefiore.org
Contact: Emma Racine 718-653-4859 ext 223 eracine@montefiore.org

Locations
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    cferrett@montefiore.org   
Principal Investigator: Eric Hollander, MD         
Sponsors and Collaborators
Montefiore Medical Center
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Eric Hollander, MD Montefiore Medical Center, Albert Einstein College of Medicine
  More Information

No publications provided

Responsible Party: Eric Hollander, Clinical Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01337687     History of Changes
Other Study ID Numbers: NARSAD Award
Study First Received: December 15, 2010
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
Autism
Autism Spectrum Disorders
Oxytocin
Hollander
ASD
Asperger Syndrome
Asperger

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014