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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests an oxytocin nasal spray to help children and adults with high functioning autism improve their social skills. The spray delivers a hormone that can enhance social behaviors. Researchers hope it will be safe and effective for this purpose. Oxytocin has been researched for its potential to improve social communication in individuals with autism spectrum disorder, though results have been mixed.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
3,006 Previous Clinical Trials
13,307,275 Total Patients Enrolled
Gagan Joshi, MDPrincipal InvestigatorMassachusetts General Hospital
11 Previous Clinical Trials
343 Total Patients Enrolled
~1 spots leftby Nov 2025
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