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Hormone Therapy

Intranasal Oxytocin for Autism

Phase 3
Waitlist Available
Led By Gagan Joshi, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is testing whether oxytocin nasal spray can help improve social skills in children and adults with ASD.

Eligible Conditions
  • Autism
  • Pervasive Developmental Disorder
  • Autism Spectrum Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with Autism Spectrum Disorder (ASD) by a doctor based on specific criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
Secondary outcome measures
Quality of Life Enjoyment and Satisfaction (PQ-LES-Q and Q-LES-Q)

Side effects data

From 2018 Phase 2 & 3 trial • 43 Patients • NCT02255357
20%
feeling energized
7%
calm
7%
less irritable
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Intranasal Syntocinon

Trial Design

2Treatment groups
Experimental Treatment
Group I: Oxytocin- Participants ages 18-55Experimental Treatment1 Intervention
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Group II: Oxytocin- Participants ages 12-17Experimental Treatment1 Intervention
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,348 Total Patients Enrolled
Gagan Joshi, MDPrincipal InvestigatorMassachusetts General Hospital
11 Previous Clinical Trials
343 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is intranasal oxytocin commonly employed?

"Although intranasal oxytocin is most often used to treat hemorrhage, this medication can also help with labour, uterine contraction, and reinforcement of labor."

Answered by AI

Are people over the age of 20 able to participate in this research?

"According to the inclusion criteria, patients that can enroll in this trial are between the ages of 12 and 55. There are a total of 462 clinical trials for patients that are younger than 12 and 698 for patients that are older than 55."

Answered by AI

Could I qualify to be a part of this research project?

"This study is looking for 60 participants with autism spectrum disorder between the ages of 12 and 55. Patients must meet the following criteria:- At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS- 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"

Answered by AI

What have been the adverse effects of Intranasal Oxytocin treatments, if any?

"Intranasal Oxytocin's Phase 3 status indicates that there is some data to support efficacy as well as multiple rounds of safety testing, so Power rates it a 3 for safety."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
Other
Pennsylvania
How old are they?
< 18
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

how long do screening visits take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have tried at least 30 other Drugs prescribed over a period of 15 years. None of these medicines have provided any long term relief.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Gagan Joshi 2017. "A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02985749.
~1 spots leftby Apr 2025
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