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

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. Identifier: NCT01931033
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment
Autism Spectrum Disorders Pervasive Developmental Disorders ASD PDD Drug: Intranasal Oxytocin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Study Start Date : October 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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).

Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT01931033

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital

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
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by Gagan Joshi, MD, Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorders

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs