1. Intranasal Oxytocin for Autism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Massachusetts General Hospital, Boston, MAAutism+2 More3. Intranasal Oxytocin spray - Drug
Eligibility
6 - 18
All Sexes
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Study Summary

This trial tests how intranasal oxytocin affects bone health in 6-18yo children with autism over 12mo. Subjects will get oxytocin or placebo and assessments throughout.

Eligible Conditions
  • Autism
  • Osteoporosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 12 months

12 months
Difference between IN OXT vs placebo in 12-month change in femoral neck areal BMD Z-score
Difference between IN OXT vs placebo in 12-month change in radial cortical area
Difference between IN OXT vs placebo in 12-month change in radial trabecular thickness
Difference between IN OXT vs placebo in 12-month change in tibial cortical area
Difference between IN OXT vs placebo in 12-month change in whole body less head areal BMD Z-score
The 12-month change in femoral neck areal BMD Z-score between IN OXT vs. placebo
The 12-month change in radial trabecular thickness between IN OXT vs. placebo
The 12-month change in the radial cortical area between IN OXT vs. placebo
The 12-month change in the whole body less head areal BMD Z-score between IN OXT vs. placebo
The 12-month change in tibial cortical area between IN OXT vs. placebo

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

1. Intranasal Oxytocin
1 of 2
2. Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

96 Total Participants · 2 Treatment Groups

Primary Treatment: 1. Intranasal Oxytocin · Has Placebo Group · Phase 2

1. Intranasal OxytocinExperimental Group · 2 Interventions: 3. Intranasal Oxytocin spray, 1. Intranasal oxytocin spray · Intervention Types: Drug, Drug
2. PlaceboPlaceboComparator Group · 2 Interventions: 3. Intranasal Oxytocin spray, 2. Intranasal placebo spray · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,737 Previous Clinical Trials
31,217,257 Total Patients Enrolled
United States Department of DefenseFED
793 Previous Clinical Trials
213,372 Total Patients Enrolled

Eligibility Criteria

Age 6 - 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a healthy weight for your height, between the 10th and 85th percentiles.

Frequently Asked Questions

Does this clinical trial allow persons aged 35 and over to participate?

"This medical trial is targeting people aged 6 to 18. According to the data, there are 423 clinical trials available for minors and 672 studies suited for senior citizens." - Anonymous Online Contributor

Unverified Answer

Who is eligible to participate in this clinical experiment?

"This clinical trial seeks 96 participants who are between the ages of 6 and 18, as well as being diagnosed with autism." - Anonymous Online Contributor

Unverified Answer

Is it feasible to participate in this experiment at the present?

"Per clinicaltrials.gov, this particular trial has concluded its recruitment phase and is no longer actively searching for participants as of February 22nd 2023. However, there are 1152 other studies with ongoing enrolment across the world at present." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned intranasal oxytocin for medical use?

"Our team has assigned an intermediate safety level of 2 to intranasal oxytocin, as the phase two trial data only supports its safety and not efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.