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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337687
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: Intranasal Oxytocin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Study Start Date : October 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: 6 Weeks ]
    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 :
  1. Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Baseline, Week 6 ]

    Clinician-Rated questionnaire measuring the time spent, distress,interference, resistance, and control in relation to obsessions and compulsions based on a 5 point scale ranging from 0-5 for each category with 0 being most desirable and 5 being least. Sub-scales are added and averaged to obtain total scores.

    -scale range (total): 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme

    Questions are rated on a 5-point scale, 0-4, increasing in severity. Obsession Rating Subscale (5 questions, ranging from 0 - 20 total) and Compulsion Rating subscale (5 questions, ranging from 0 - 20 total) are totaled and added to obtain total scores.

    -score interpretation: Higher overall scores reflect increasing symptom severity.


  2. Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R) [ Time Frame: Baseline, week 6 ]

    Subscale ranges: stereotypic behavior (0 - 27);self-injurious behavior (0 - 24); compulsive behavior (0 - 18); ritualistic/Sameness Behavior (0 - 36); restricted Interests (0 - 9).

    Higher score in all subscales reflect increasing severity. Questions rate behaviors on a 4-point scale: 0 = does not occur; 1 = occurs, mild problem; 2 = occurs, moderate problem; 3 = occurs, severe problem. Subscale scores consist of sum of ratings within each question subset.

    Lower order behaviors-- stereotypy and self-injury, higher order behaviors--compulsions, rituals /sameness, restricted interests.

    Lower Order total range: 0-51, Higher Order total range: 0-63 Stereotypic behavior and Self-injurious behavior subscales were summed to create a total range for Lower Order behavior; and Compulsive behavior, ritualistic /sameness behavior, and restricted interests subscales were summed to create a total range for Higher Order behavior.


  3. Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2) [ Time Frame: baseline, week 6 ]

    A clinical tool measuring emotion recognition through facial expression, voice and posture.

    1. Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)
    2. Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)
    3. Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)
    4. Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337687


Locations
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United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
National Alliance for Research on Schizophrenia and Depression
Investigators
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Principal Investigator: Eric Hollander, MD Montefiore Medical Center/Albert Einstein College of Medicine
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Responsible Party: Eric Hollander, Clinical Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01337687    
Other Study ID Numbers: 09-10-303
First Posted: April 19, 2011    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020
Last Verified: February 2020
Keywords provided by Eric Hollander, Montefiore Medical Center:
Autism
Autism Spectrum Disorders
Oxytocin
Hollander
ASD
Asperger Syndrome
Asperger
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs