OXYTOCIN for Healthy children

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
• {"criterion_text":"- Participants must have an age that is between 9 and 13 years old"}

Exclusion criteria

• {"criterion_text":"- Participant has a history of an oxytocin allergy"}
• {"criterion_text":"- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol"}
• {"criterion_text":"- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial"}
• {"criterion_text":"- Participation in an interventional Trial with an investigational medicinal product (IMP) or device"}
• {"criterion_text":"- A kidney or cardial condition"}
• {"criterion_text":"- Participant is taking any medication at the time of testing"}

Primary endpoints

• {"endpoint_text":"- To assess whether oxytocin affects cognitive flexibility, we will analyze perseverative errors during the PRLT and compare these errors in children that received oxytocin vs. children that received the placebo. We expect that oxytocin will attenuate learning during this test. More specifically, children that receive oxytocin will make more perseverative errors than children who received the placebo.","definition_or_measurement_approach":"Measure: perseverative errors during the Probabilistic Reversal Learning Task (PRLT); comparison between oxytocin and placebo groups."}
• {"endpoint_text":"- To assess the effect of oxytocin on trust behaviour, we will analyze the changes in self-reported trust (computing a difference score comparing trust after the baseline vs. after the test. We expect to find less trust behavior decrease after the test block in the 80% baseline block condition for children who receive oxytocin (Study 1). For the other children, we predict stronger decreases in trust behavior (Study 1).","definition_or_measurement_approach":"Measure: change in self-reported trust (difference score baseline vs after test); group comparison by treatment and baseline block condition (80% baseline block described)."}
• {"endpoint_text":"- To assess the effect of oxytocin on trust behaviour, we will analyze the changes in self-reported trust (computing a difference score comparing trust after the baseline vs. after the test. We expect to find less trust behavior increase after the test block in the 20% baseline block condition for children who receive oxytocin (Study 2). For the other children, we predict stronger increases in trust behavior (Study 2).","definition_or_measurement_approach":"Measure: change in self-reported trust (difference score baseline vs after test); group comparison by treatment and baseline block condition (20% baseline block described)."}
• {"endpoint_text":"- To assess whether oxytocin attenuates dopamine responses, we will test between subsequent trials whether oxytocin decreases the negative impact of prediction error on decreases in attentional preference for mother after prediction error trials. For this purpose, we will compare performance on prediction error trials versus trials without prediction error.","definition_or_measurement_approach":"Measure: comparison of performance on prediction error trials versus non-prediction-error trials; assess changes in attentional preference for mother and infer attenuation of dopamine responses by oxytocin."}

Belgium

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

481

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium