Ocytocine and Cerebral Activation in Relation With Attachement

Phase 2

Completed

• Conditions: Attachement Style
• Interventions: Drug: nasal oxytocin or placebo; Device: fMRI; Behavioral: Attachement scale interview (ASI); Behavioral: psychometric scales

• Registration Number: NCT02847143
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The study aims to characterize the cerebral activation modifications related to nasal oxytocin administration during vizualisation of distress images in population of healthy people with different attachement styles.

Detailed Description

Healthy adult male will be recruited. Their attachement style will be assessed through the Attachement scale interview (ASI).

They will have 2 fMRI sessions, during which emotional images will be presented.

One session will be preceded by a nasal administration of oxytocin and the other session will be preceded by a placebo nasal administration. The order of both administrations will be randomized.

Study Timeline

• Study Start: 2015-04-09
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Status Verified: 2021-06
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• comprehension of french
• having signed the informed consent

Exclusion Criteria

• chronic disease (liver failure, kidney failure) and cardiovascular disease
• hypertensive treatment
• treatment wich increases QT
• current hospitalisation
• fMRI contraindication
• legal protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
secure	psychometric scales	healthy adult male with secure attachement
avoidant	fMRI	healthy adult male with avoidant attachement
secure	nasal oxytocin or placebo	healthy adult male with secure attachement
enmeshed/fearfull	nasal oxytocin or placebo	healthy adult male with enmeshed/fearfull attachement
dual style	Attachement scale interview (ASI)	healthy adult male with dual attachement style
avoidant	Attachement scale interview (ASI)	healthy adult male with avoidant attachement
dual style	nasal oxytocin or placebo	healthy adult male with dual attachement style
secure	fMRI	healthy adult male with secure attachement
secure	Attachement scale interview (ASI)	healthy adult male with secure attachement
avoidant	nasal oxytocin or placebo	healthy adult male with avoidant attachement
enmeshed/fearfull	fMRI	healthy adult male with enmeshed/fearfull attachement
avoidant	psychometric scales	healthy adult male with avoidant attachement
enmeshed/fearfull	Attachement scale interview (ASI)	healthy adult male with enmeshed/fearfull attachement
enmeshed/fearfull	psychometric scales	healthy adult male with enmeshed/fearfull attachement
dual style	fMRI	healthy adult male with dual attachement style
dual style	psychometric scales	healthy adult male with dual attachement style

Primary Outcome Measures

Name	Time	Method
BOLD signal intensity	45 min after intranasal administration of oxytocin or placebo	BOLD signal will be assessed in the brain regions associated with attachement: amygdala, medial prefrontal cortex and dorsolateral prefrontal cortex.; Both conditions (placebo vs axytocin) will be compared in the four groups. BOLD signal will be assessed during the visualization of emotional pictures that ellicit distress, comfort or complicity or neural emotion.

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besancon, Doubs, France