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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01931033
First received: August 22, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
ASD
PDD
Drug: Intranasal Oxytocin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2016
Estimated Primary Completion Date: November 2016 (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

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female outpatients ages 11-17 years
  2. DSM-IV-TR Pervasive developmental disorder (PDD) diagnosis of autistic disorder, Asperger's disorder, or PDD Not Otherwise Specified (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. Intelligence Quotient (IQ) <85
  2. Total lack of spoken language
  3. DSM-IV-TR PDD (Pervasive Developmental Disorder) 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 (Liver function tests > 3 times upper limit of normal) 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. Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  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 ClinicalTrials.gov identifier: NCT01931033

Contacts
Contact: Stephannie Furtak 617-724-2344 sfurtak1@partners.org
Contact: Rebecca Grossman 617-643-1432 Rgossman1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Stephannie Furtak    617-724-2344    Sfurtak1@partners.org   
Principal Investigator: Gagan Joshi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gagan Joshi, MD, Medical Director, Bressler Program for Autism Spectrum Disorders, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01931033     History of Changes
Other Study ID Numbers: 2013-P-001548
Study First Received: August 22, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorders
ASD
PDD
Oxytocin
Syntocinon
treatment

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Developmental Disabilities
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014