Oxytocin and attachment development: Looking beyond the expected?

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Psychological Phenomena [F02]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2024-12-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518004-49-00

EudraCT number

2022-000156-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

We will use principles deduced from the Learning Theory of Attachment (LTA) to evaluate to what extent oxytocin has attenuating effects on trust learning. To this end, we will conduct a VR experiment because it allows us to study the dynamics underlying trust learning in a realistic setting. In addition, we will conduct a task that assesses cognitive flexibility, namely the Probabilistic Reversal Learning Task (PRLT), to test whether the possible attenuating effects of oxytocin are limited to the level of social learning or also extend to a more basic level of learning.

Conditions and MedDRA coding

Healthy children

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Participants must have an age that is between 9 and 13 years old

Exclusion criteria 6

1. Participant has a history of an oxytocin allergy
2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
5. A kidney or cardial condition
6. Participant is taking any medication at the time of testing

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. 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.
2. 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).
3. 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).
4. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Kristina Casteels

Public contact point

Organisation

UZ Leuven

Contact name

Kristina Casteels

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications