Clinical trial NCT01337687: Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Official title: Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Autism
Autism Spectrum Disorders
Oxytocin
Hollander
ASD
Asperger Syndrome
Asperger
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2011-04-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Male and Female
* 18 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

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

Primary outcomes:
measure: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline, Week 6
measure: Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R)
timeFrame: Baseline, week 6
measure: Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2)
timeFrame: baseline, week 6
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Eric Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References: