AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, placebo-controlled, double-blind, 2-period cross-over study in youth with autism spectrum disorders evaluating social and repetitive behaviors after four weeks of twice daily-doses of 24IU of intranasally administered oxytocin

This study is investigating whether a specific nose spray containing a substance called oxytocin can help young people with autism. For four weeks, participants will use the nose spray twice a day. The main goal is to see if this treatment improves social skills and reduces repetitive behaviours. Caregivers will help by completing questionnaires about changes they observe in these areas. The study is comparing the oxytocin spray to a placebo (a spray with no active medicine) to understand its real effects. This is an early stage study (Phase II) to explore if this approach is promising.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital HF

Enrolment target

128

Start

09 Oct 2024

Autism spectrum disorder

What is this study about?

This study is looking into a new way to help young people with autism spectrum disorder. We're exploring if a special nose spray, which contains a substance called oxytocin, could help improve social interactions and lessen repetitive behaviours. Oxytocin is a chemical naturally found in the body that plays a role in social connections.

Participants in this study will use the nose spray twice a day for four weeks. Some will get the oxytocin spray, while others will get a 'dummy' spray called a placebo, which looks and feels the same but contains no active medicine. Neither the participants, their families, nor the study team will know who is getting which spray. This helps us get the most accurate results.

The main things we want to find out are whether the oxytocin spray leads to improvements in how participants socialise and if it helps reduce repetitive actions. Families will play a key role by filling out questionnaires about any changes they notice in these areas. We'll also be looking at other behaviours, like how flexible someone is with their daily routines.

Key takeaways

This study evaluates a nose spray with oxytocin for young people with autism.
It aims to see if the spray can improve social skills and repetitive behaviours.
The study lasts four weeks, with participants using the spray twice daily.
A 'dummy' spray (placebo) is used for comparison to get accurate results.
Caregivers will help by completing questionnaires about observed changes.
This is an early-stage study to explore the treatment's potential.

Who may be eligible?

This study is open to both male and female young people who have been diagnosed with autism spectrum disorder. All participants must be 18 years old or older.

There might be other specific health requirements or conditions that could affect whether someone can join. These are put in place to ensure the safety of everyone taking part and to make sure the study results are clear.

If you or someone you know might be interested, it's best to discuss it with your doctor or the study team to find out all the exact details and see if they would be a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of autism spectrum disorder?
Are you able to use a nose spray twice a day?
Are your caregivers able to complete questionnaires about your behaviour?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll use a nose spray twice a day for four weeks. For part of the study, you'll get the active oxytocin spray, and for another part, you'll get a placebo (a spray with no active medicine). You won't know which one you're getting at any time. Throughout the study, you'll have appointments where the study team will check your health and progress. Caregivers will be asked to fill out questionnaires about social skills and repetitive behaviours. The total length of your involvement, including all spray periods and follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by exploring if the oxytocin nose spray can improve social skills or reduce repetitive behaviours. However, as with any medical study, there are potential risks, which could include side effects from the spray, though the study aims to be as safe as possible. You will be fully informed of all known and potential risks before deciding to join. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is oxytocin?

Oxytocin is a natural body chemical often called the 'love hormone' because it plays a role in social bonding and relationships.

What does 'placebo-controlled' mean?

It means some people get the actual medicine (oxytocin spray) and others get a 'dummy' spray that looks and feels the same but has no active medicine. This helps us see if the oxytocin spray truly makes a difference.

What is 'double-blind'?

It means that neither you, your family, nor the study doctors will know whether you are receiving the oxytocin spray or the placebo, until the study is over. This helps keep the results unbiased.

How will you measure if the spray works?

Caregivers will fill out special questionnaires about social skills and repetitive behaviours. We'll compare these answers from before and after using the spray to see if there are any changes.

Can I still get my usual care if I join?

Yes, taking part in this study will not affect your ability to receive your usual medical care and support.