Oxytocin Effects on Bone in Children with Autism Spectrum Disorder

PHASE2RecruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2026

Conditions
Autism Spectrum DisorderBone Health
Interventions
DRUG

1. Intranasal oxytocin spray

30 IU, twice daily for 12 months in the experimental arm in double-blinded phase

DRUG

2. Intranasal placebo spray

30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase

DRUG

3. Intranasal Oxytocin spray

30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase

Trial Locations (2)

22903

RECRUITING

University of Virginia Medical Center, Charlottesville

02114

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

University of Virginia

OTHER

lead

Elizabeth Austen Lawson

OTHER