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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985749
• Other study ID #: 2016P002148
• Status: Completed
• Phase: Phase 3
• Start date: October 9, 2017
• Est. completion date: January 9, 2019

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 55 Years

Eligibility

Inclusion Criteria:

• Males and females between 12 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.

Related Conditions & MeSH terms

• ASD
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• PDD
• Pervasive Developmental Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8	Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale.; The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.	8 weeks