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Hormone Therapy

Intranasal Oxytocin for Autism Spectrum Disorder

N/A
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
At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week-8
Awards & highlights

Study Summary

This trial tests oxytocin nasal spray as a treatment for social impairment in adolescents with ASD. The hypothesis is that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of ASD in adolescents ages 11-17.

Eligible Conditions
  • Autism Spectrum Disorder
  • Pervasive Developmental Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a moderate or severe level of impairment related to autism, as measured by certain tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week-8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week-8 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 Scales 2 (SRS-2) Scales From Baseline to Week 8
Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8
Secondary outcome measures
Clinical Global Impression of PDD - Improvement (CGI-I)

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

1Treatment groups
Experimental Treatment
Group I: OxytocinExperimental 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
13,198,347 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,120 Patients Enrolled for Autism Spectrum Disorder
Gagan Joshi, MDPrincipal InvestigatorMassachusetts General Hospital
11 Previous Clinical Trials
342 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
329 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

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

How many people have signed up to be a part of this research project?

"This study is not recruiting patients at the moment. The clinical trial was originally advertised on October 1st, 2013 and updated for the final time on July 29th, 2022. However, there are presently 1194 other clinical trials actively enrolling patients with autism spectrum disorder and 57 trials for Intranasal Oxytocin that are still looking for participants."

Answered by AI

What therapeutic effects does Intranasal Oxytocin generally provide?

"Oxytocin, which can be administered intranasally, is often used to treat hemorrhage. However, it has also been effective in other medical situations such as uterine contractions during labor and reinforcement of labor."

Answered by AI

Does this research exclude people who are over a certain age?

"This research is enrolling those who are pre-pubescent to early adolescence, aged 11 through 17."

Answered by AI

How can I sign up for the research project?

"This autism spectrum disorder clinical trial requires that potential participants be between 11 and 17 years old. The team is looking for approximately 40 individuals to take part in the study."

Answered by AI

Are researchers still enrolling people for this trial?

"As of 7/29/2022, this clinical trial is no longer actively recruiting patients. If you are interested in other trials, there are 1194 active autism spectrum disorder studies and 57 Intranasal Oxytocin trials currently enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Gagan Joshi 2013. "An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01931033.
~1 spots leftby Apr 2025
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