Oxytocin and the development of attachment: Looking beyond the expected?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000156-11-BE

Enrollment

200

Registered

2022-01-27

Start date

2022-02-25

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General healthy population children (ages 8 - 13 years old).

Interventions

Trade Name: Syntocinon (oxytocin), nasal spray 40 IE/ml Product Name: Syntocinon (oxytocin) Pharmaceutical Form: Nasal spray INN or Proposed INN: OXYTOCIN CAS Number: 50-56-6 Current Sponsor code: S65

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: General population children between the age of 8 and 13 years old. Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: In the current study, we use principles of the Learning Theory of Attachment (LTA), which proposes that the development of attachment can be partly explained as a result of a learning process, to investigate the role of oxytocin in the development of attachment. Previous research found that oxytocin attenuates prediction error which suggests that oxytocin can affect plasticity. Based on the LTA, we specify concrete hypotheses and by manipulating contingency in different trials, we can assess how oxytocin affects trust learning on a trial-by-trial basis. Furthermore, we want to assess whether the effect of oxytocin also extends to a more basic level. Secondly, because of the potential attenuating effect of oxytocin on the encoding of prediction error, we will focus on the dopamine system as explanatory mechanism. Previous research pointed to a crucial role for the dopamine system in updating of safety conditioning and encoding prediction error.;Secondary Objective: Not applicable.;Primary end point(s): This study will provide information on the effects of oxytocin during trust learning as well as during a more basic level of learning (cognitive flexibility). Furthermore, this study might identify the dopamine system as neural system through which oxytocin exerts its effects. The anticipated end point is that oxytocin will have an attenuating effect on both trust learning and basic learning which possibly will be explained by the dopamine system.;Timepoint(s) of evaluation of this end point: The trial is anticipated to end at the end of 2025.	—

Measure

Time frame

Main Objective: In the current study, we use principles of the Learning Theory of Attachment (LTA), which proposes that the development of attachment can be partly explained as a result of a learning process, to investigate the role of oxytocin in the development of attachment. Previous research found that oxytocin attenuates prediction error which suggests that oxytocin can affect plasticity. Based on the LTA, we specify concrete hypotheses and by manipulating contingency in different trials, we can assess how oxytocin affects trust learning on a trial-by-trial basis. Furthermore, we want to assess whether the effect of oxytocin also extends to a more basic level. Secondly, because of the potential attenuating effect of oxytocin on the encoding of prediction error, we will focus on the dopamine system as explanatory mechanism. Previous research pointed to a crucial role for the dopamine system in updating of safety conditioning and encoding prediction error.;Secondary Objective: Not applicable.;Primary end point(s): This study will provide information on the effects of oxytocin during trust learning as well as during a more basic level of learning (cognitive flexibility). Furthermore, this study might identify the dopamine system as neural system through which oxytocin exerts its effects. The anticipated end point is that oxytocin will have an attenuating effect on both trust learning and basic learning which possibly will be explained by the dopamine system.;Timepoint(s) of evaluation of this end point: The trial is anticipated to end at the end of 2025.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactSamuel Budniok

KU Leuven

samuel.budniok@kuleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026