Ocytocine and Cerebral Activation in Relation With Attachement (OTACLA)

October 1, 2024 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: secure
healthy adult male with secure attachement
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
Behavioral: 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)
Experimental: avoidant
healthy adult male with avoidant attachement
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
Behavioral: 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)
Experimental: enmeshed/fearfull
healthy adult male with enmeshed/fearfull attachement
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
Behavioral: 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)
Experimental: dual style
healthy adult male with dual attachement style
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
Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 min after intranasal administration of oxytocin or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Lauriane VULLIEZ-COADY, MD, CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2015

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimated)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2014/237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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