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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
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.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The 12-month change in the whole body less head areal BMD Z-score between IN OXT vs. placebo
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,405 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,032 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
863 Previous Clinical Trials
227,503 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,644 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart issues, including coronary disease or heart failure.I have a genetic condition like Fragile X or tuberous sclerosis.I have a condition that could cause low bone density.I am not taking medications that affect bone health.My antipsychotic medication dose has not changed in the last 2 months.I have had seizures in the last 6 months.I have not taken OXT in the last 2 months.I am between 6 and 18 years old.I am mentally capable of understanding and agreeing to the trial.
Research Study Groups:
This trial has the following groups:- Group 1: 1. Intranasal Oxytocin
- Group 2: 2. Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT05754073 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've tried at least three other drugs with no long term relief of negative social symptoms related to my Autistic diagnosis. I.E. Depression, acute anxiety, threats of suicide and suicidal ideation.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
how many visits to your evaluation site are necessary?
PatientReceived 1 prior treatment
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