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Completed

NCT Number: NCT02847143

Ocytocine and Cerebral Activation in Relation With Attachement

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.

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Key information

Conditions

Attachement Style

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

CHU Besancon

Besançon, Doubs, 25030, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal oxytocin or placebo

Drug

nasal administration of oxytocin or palcebo 45 min befor fMRI session

fMRI

Device

FMRI during emotional image visualization

Attachement scale interview (ASI)

Behavioral

this scale is used to determine the attachement style of each participant

psychometric scales

Behavioral

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)

Primary outcomes

  1. BOLD signal intensity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: OTACLA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2016
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.