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

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: NCT02985749
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Autism Spectrum Disorder Pervasive Developmental Disorder ASD PDD Drug: Intranasal Oxytocin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 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

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): NCT02985749


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

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

Keywords provided by Gagan Joshi, MD, 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