Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Massachusetts General Hospital
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital Identifier:
First received: August 22, 2013
Last updated: December 22, 2016
Last verified: December 2016
This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD). We hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.

Condition Intervention
Autism Spectrum Disorders
Pervasive Developmental Disorders
Drug: Intranasal Oxytocin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Social Responsiveness Scale (SRS-2) [ Time Frame: Week-8 ]
    A 65-item rating scale completed by the secondary reporter used to measure the severity of autism spectrum symptoms as they occur in natural settings.

Secondary Outcome Measures:
  • Clinical Global Impression of PDD - Improvement (CGI-I) [ Time Frame: Week-8 ]
    The CGI is a measure of illness severity, improvement, and efficacy of treatment (National Institute of Mental Health, 1985). The score for Improvement ranges from 1 (very much improved) to 7 (very much worse).

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Drug: Intranasal Oxytocin
Other Name: Syntocinon


Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Male and female outpatients ages 11-17 years
  2. DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL).
  3. At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD.
  4. Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol.
  5. Subjects and their parent/guardian must be considered reliable reporters.
  6. Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
  7. Subjects must be able to participate in mandatory blood draws.
  8. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria

  1. IQ <85
  2. Total lack of spoken language
  3. DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder.
  4. Clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator.
  5. History of substance use (except nicotine or caffeine) within past 3 months
  6. Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  7. Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely impaired renal function (eGFR < 30).
  8. Pregnant or nursing females.
  9. Known hypersensitivity to oxytocin.
  10. Severe allergies or multiple adverse drug reactions.
  11. A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
  12. Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
  13. Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  14. Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01931033

Contact: Ryan Kilcullen 617-724-7301
Contact: Alexa Pulli, BS 617-726-4651

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Kilcullen    617-724-7301   
Contact: Leah Feinberg, BS    617-726-4651   
Principal Investigator: Gagan Joshi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

Responsible Party: Gagan Joshi, MD, Medical Director, Bressler Program for Autism Spectrum Disorders, Massachusetts General Hospital Identifier: NCT01931033     History of Changes
Other Study ID Numbers: 2013-P-001548
Study First Received: August 22, 2013
Last Updated: December 22, 2016

Keywords provided by Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorders

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Developmental Disabilities
Pathologic Processes
Reproductive Control Agents
Physiological Effects of Drugs processed this record on May 23, 2017