Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders

NCT01337687 | Completed Results

• 1 other identifier: 09-10-303
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.

Conditions

Autism Spectrum Disorders

Keywords

Autism; Autism Spectrum Disorders; Oxytocin; Hollander; ASD; Asperger Syndrome; Asperger

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale

  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.

  6 Weeks

Secondary Outcomes (3)

• Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS)

  Baseline, Week 6

• Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R)

  Baseline, week 6

• Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2)

  baseline, week 6

Study Arms (2)

Oxytocin

EXPERIMENTAL

Drug: Intranasal Oxytocin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Intranasal Oxytocin DRUG

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

Oxytocin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female
• to 55 years old
• Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome
• Have a high, normal or near normal Intelligent Quotient
• Speak and Understand English fluently

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Casara Jean Ferretti
• Organization: Montefiore Medical Center, Albert Einstein College of Medicine

cferrett@montefiore.org

3472499694

Study Officials

• Eric Hollander, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: April 19, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Locations

US (1)