BridgeMD
A randomized, placebo-controlled, double-blind, 3-period cross-over study in youth with autism spectrum disorders evaluating neural plasticity and learning after a single administration of intranasal oxytocin
EU CTIS ID: 2023-506826-36-00
What this study is testing
Identify effects of oxytocin delivered intranasally (8 IU and 24 IU) on neural plasticity and learning compared to placebo in youth diagnosed with ASD
- 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
- 1. Male and female participant between the ages of 12 and 25, both inclusive
- 1. Participants and their caregivers (if applicable) must be able to communicate with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.
- 2. Participants must have a confirmed diagnosis of autism spectrum disorder (ASD)
You likely can't join if
- Previous nasal disease, surgery, and dependence on inhaled drugs
- Full scale IQ below 70 (due to the prerequisite ability to complete self-report measures)
- Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at the experimental sessions for all menstruating individuals)
- Currently breastfeeding
- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment
- Current significant nasal congestion due to common colds
See the full eligibility criteria
- 1. Male and female participant between the ages of 12 and 25, both inclusive
- 1. Participants and their caregivers (if applicable) must be able to communicate with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information.
- 2. Participants must have a confirmed diagnosis of autism spectrum disorder (ASD)
- Previous nasal disease, surgery, and dependence on inhaled drugs
- Full scale IQ below 70 (due to the prerequisite ability to complete self-report measures)
- Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at the experimental sessions for all menstruating individuals)
- Currently breastfeeding
- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment
- Current significant nasal congestion due to common colds
- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder
- Epilepsy and previous history of photosensitive seizures
- Systemic illness requiring treatment within 2 weeks prior to Study Day 1
- 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
- New concomitant medications or formal cognitive/behavioural therapies. If a participant has been taking any medications or receiving formal cognitive/behavioural therapies for at least 4 weeks, then this is not considered a new therapy
- Participation in any (other) clinical trial with an investigational medicinal product or medical device within 1 month prior to randomization
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.