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Intranasal oxytocin in youth with autism
EU CTIS ID: 2024-512387-56-00
What this study is testing
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior and repetitive behavior.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participant between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS).
- Participants must be in good general physical health, as determined by the investigator.
- Participants must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.
- Provision of a signed, written informed consent, if 16 years and older. Participants between the ages of 12 and 15 (inclusive) will provide assent, with caregivers providing consent. Caregivers will also provide consent for research participation.
You likely can't join if
- Previous nasal disease, surgery, and dependence on inhaled drugs.
- Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
- New concomitant medications or formal cognitive/behavioral therapies. If a participant has been taking any medications or receiving formal cognitive/behavioral therapies for at least 4 weeks, then this is not considered a new therapy.
- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrollment.
- Current significant nasal congestion due to common colds.
- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
See the full eligibility criteria
- Male and female participant between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS).
- Participants must be in good general physical health, as determined by the investigator.
- Participants must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.
- Provision of a signed, written informed consent, if 16 years and older. Participants between the ages of 12 and 15 (inclusive) will provide assent, with caregivers providing consent. Caregivers will also provide consent for research participation.
- Previous nasal disease, surgery, and dependence on inhaled drugs.
- Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
- New concomitant medications or formal cognitive/behavioral therapies. If a participant has been taking any medications or receiving formal cognitive/behavioral therapies for at least 4 weeks, then this is not considered a new therapy.
- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrollment.
- Current significant nasal congestion due to common colds.
- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
- Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).
- Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate.
- Known allergic reactions or hypersensitivity/intolerance to latex.
- Currently breastfeeding.
- Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 3 for all menstruating females).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.