What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include intranasal oxytocin, omega-3 fatty acids, cannabinoids, and melatonin. Intranasal oxytocin has been associated with side effects such as somnolence, decreased appetite, irritability, and restlessness. Omega-3 fatty acids may cause gastrointestinal distress, including nausea and diarrhea. Cannabinoids can lead to somnolence, decreased appetite, irritability, restlessness, and in some cases, elevated liver aminotransferase concentrations. Melatonin is generally well-tolerated but can cause minor side effects such as dizziness and daytime drowsiness. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder: aripiprazole and risperidone. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. While intranasal oxytocin is being studied for its potential effects on social behaviors and bone metabolism in children with ASD, it has not yet received FDA approval for these uses. Current research on oxytocin is promising but remains inconclusive.

What other types of research exist?

One promising alternative to intranasal oxytocin for ASD patients is the use of C-type natriuretic peptide (CNP) analogues, such as vosoritide. Vosoritide has shown potential in clinical trials for children with achondroplasia, a condition that shares some bone growth challenges with ASD. Additionally, therapies targeting the FGFR3 pathway, such as soluble FGFR3, have demonstrated efficacy in preclinical models for improving bone growth and health. These alternatives could offer novel approaches to managing bone metabolism and overall health in ASD patients.

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Hormone Therapy

Oxytocin Nasal Spray for Autism

Phase 2

Recruiting

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 12 months

Awards & highlights

Summary

This trial tests if giving oxytocin through a nasal spray can improve bone health in children with autism. Children with autism often have weaker bones and lower levels of oxytocin. The study aims to see if oxytocin can help make their bones stronger. Oxytocin has been investigated for its potential to treat social deficits in autism spectrum disorders, with various studies exploring its effects on social behavior and brain function.

Who is the study for?

This trial is for children aged 6-18 with Autism Spectrum Disorder who can give informed assent/consent and have a parent/guardian to consent. They must be within the 10th-85th BMI percentiles, not on certain medications or have conditions affecting bone density, and cannot be pregnant or refuse contraception if sexually active.

What is being tested?

The study tests intranasal oxytocin's effects on bone health in autistic children versus a placebo. Participants will use the spray twice daily for a year, then all receive oxytocin for another six months. The trial includes regular visits and calls, physical exams, EKGs, lab tests for bone metabolism markers, diet/exercise questionnaires, and imaging of bones.

What are the potential side effects?

Potential side effects may include irritation at the administration site (nose), headache, nausea or changes in appetite. Since it involves hormone treatment there might also be mood alterations or other hormonal-related changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The 12-month change in the whole body less head areal BMD Z-score between IN OXT vs. placebo

Secondary study objectives

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

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1. Intranasal OxytocinExperimental Treatment2 Interventions

Intranasal oxytocin spray (30 IU twice daily) for 12 months in the double-blinded phase followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase

Group II: 2. PlaceboPlacebo Group2 Interventions

Intranasal placebo spray (30 IU twice daily (total 60 IU per day) for 12 months followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intranasal oxytocin is being studied for its potential to improve social deficits in ASD by enhancing social cognition and reducing repetitive behaviors. Oxytocin is a peptide hormone that influences social bonding and stress responses, which are often impaired in ASD. Other common treatments include behavioral and educational interventions that target social skills, communication, and adaptive behaviors. These interventions are crucial as they address core symptoms of ASD, helping patients improve their social interactions and overall quality of life. Additionally, melatonin is used to manage sleep disturbances in ASD, improving sleep onset and duration, which is vital for overall health and daily functioning.

Quantitative facial expression analysis revealed the efficacy and time course of oxytocin in autism.[Development of Novel Therapeutics for Core Symptoms of Autism Spectrum Disorder: An Integrative Approach of Clinical Trials, Neuroimaging, and Genomics].Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

891 Previous Clinical Trials

332,382 Total Patients Enrolled

18 Trials studying Autism Spectrum Disorder

1,653 Patients Enrolled for Autism Spectrum Disorder

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,625 Total Patients Enrolled

42 Trials studying Autism Spectrum Disorder

3,032 Patients Enrolled for Autism Spectrum Disorder

Media Library

Intranasal oxytocin spray (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05754073 — Phase 2

Autism Spectrum Disorder Research Study Groups: 1. Intranasal Oxytocin, 2. Placebo

Autism Spectrum Disorder Clinical Trial 2023: Intranasal oxytocin spray Highlights & Side Effects. Trial Name: NCT05754073 — Phase 2

Intranasal oxytocin spray (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05754073 — Phase 2

Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT05754073 — Phase 2

~48 spots leftby Oct 2025

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