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A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02985749
First received: November 17, 2016
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in improving social deficits in individuals with ASD.

Condition Intervention Phase
Autism Spectrum Disorder
Pervasive Developmental Disorder
ASD
PDD
Drug: Intranasal Oxytocin
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Pilot Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Social Responsiveness Scale (SRS-2 School Age form and SRS-2 Adult Self-Report) [ Time Frame: 8 weeks ]
    A 65-item rating scale will be completed by the participant (ages 18-55) or the participant's parent/guardian (ages 6-17) to measure the severity of autism spectrum symptoms as they occur in natural settings.


Secondary Outcome Measures:
  • Quality of Life Enjoyment and Satisfaction (PQ-LES-Q and Q-LES-Q) [ Time Frame: 8 weeks ]
    A 15-item rating scale will be completed by the participant (ages 18-55) or the participant's parent/guardian (ages 6-17) to assess the quality of life from the subject's perspective.


Estimated Enrollment: 60
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2019 (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
This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
Other Name: Syntocinon

  Eligibility

Ages Eligible for Study:   6 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 6 and 55 years of age.
  • Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview
  • At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS
  • 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.
  • Subjects and their parent/guardian must be considered reliable reporters. They must understand the nature of the study and must sign an IRB-approved informed consent form before initiation of any study procedures. Subjects and their parent/guardian must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
  • Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
  • Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
  • If the subject is sexually active, he/she must agree to use an acceptable form of birth control during the study. These include:
  • Abstinence (no sexual contact)
  • A barrier method (diaphragm plus spermicide or a condom plus spermicide) in addition to one of the following methods:
  • Consistent use of an approved birth control pill
  • Birth control patch
  • Injected contraceptives
  • Intrauterine device (IUD)

Exclusion Criteria:

  • Impaired intellectual functioning and/or impaired spoken language.
  • Clinically unstable psychiatric conditions or any serious medical illness, which will be assessed by study clinicians during the psychiatric interview and medical history review. If the clinical assessment suggests a psychiatric or medical condition demanding acute clinical attention, then the subject will be excluded from participating in the trial.
  • Clinically unstable psychiatric conditions.
  • Any serious medical illness
  • Pregnant or nursing females.
  • Known hypersensitivity to oxytocin.
  • Severe allergies or multiple adverse drug reactions.
  • A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
  • Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
  • Clinically abnormal baseline laboratory values falling significantly outside of the standard reference ranges for a basic metabolic screen.
  • Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  • 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 ClinicalTrials.gov identifier: NCT02985749

Contacts
Contact: Ryan Kilcullen 6170724-7301 jrkilcullen@mgh.harvard.edu
Contact: Alexa P Pulli, BS 617-726-4651 apulli@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Kilcullen    617-724-7301    jrkilcullen@mgh.harvard.edu   
Contact: Alexa Pulli, BS    617-726-4651    apulli@mgh.harvard.edu   
Principal Investigator: Gagan Joshi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT02985749     History of Changes
Other Study ID Numbers: 2016P002148
Study First Received: November 17, 2016
Last Updated: March 21, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorder
ASD
PDD
Oxytocin
Syntocinon
Social Impairment
Treatment

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

ClinicalTrials.gov processed this record on March 24, 2017