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.
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¿De qué trata este estudio?
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.
Puntos clave
- 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.
¿Quién puede ser elegible?
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.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes 18 años o más?
- 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?
¿En qué consiste la participación?
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.
Riesgos y beneficios potenciales
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Preguntas comunes
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.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.