Ocytocine and Cerebral Activation in Relation With Attachement

Attachement Style Clinical Trial

— OTACLA  

Official title:

A Cross Over Randomized Controlled Trial of the Effect of Nasal Ocytocine on Cerebral Activations in Relation With Attachement in the General Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847143
• Other study ID #: P/2014/237
• Status: Completed
• Phase: Phase 2
• Start date: April 9, 2015
• Est. completion date: April 27, 2018

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Attachement Style

Intervention

Drug:
• nasal oxytocin or placebo
nasal administration of oxytocin or palcebo 45 min befor fMRI session

Device:
• fMRI
FMRI during emotional image visualization

Behavioral:
• Attachement scale interview (ASI)
this scale is used to determine the attachement style of each participant
• psychometric scales
self adminstrated questionnaires which asses the level of anxiety (Spielberger State-trait anxiety interview-STAI), depression (Beck depression inventory-BDI) and alexithymia (Toronta Alexuthymia scale-TAS 20)

Locations

Country	Name	City	State
France	CHU Besancon	Besancon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal intensity	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.	45 min after intranasal administration of oxytocin or placebo