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

NCT02985749 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2016P002148
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Pervasive Developmental Disorder; ASD; PDD

Keywords

Autism Spectrum Disorders; Pervasive Developmental Disorder; ASD; PDD; Oxytocin; Syntocinon; Social Impairment; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oxytocin- Participants ages 12-17

EXPERIMENTAL

Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.

Drug: Intranasal Oxytocin

Oxytocin- Participants ages 18-55

EXPERIMENTAL

Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.

Drug: Intranasal Oxytocin

Interventions

Intranasal Oxytocin DRUG

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).

Also known as: Syntocinon

Oxytocin- Participants ages 12-17; Oxytocin- Participants ages 18-55

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Child Development Disorders, Pervasive

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Gagan Joshi, MD
• Organization: Massachusetts General Hospital

gjoshi@mgh.harvard.edu

617-724-1541

Study Officials

• Gagan Joshi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Bressler Program for Autism Spectrum Disorders

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 7, 2016
• Study Start: October 9, 2017
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: July 1, 2024
• Results First Posted: August 16, 2023

Record last verified: 2024-06

Locations

US (1)