NCT02847143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2018

Completed
Last Updated

October 2, 2024

Status Verified

June 1, 2021

Enrollment Period

3.1 years

First QC Date

July 25, 2016

Last Update Submit

October 1, 2024

Conditions

Attachement Style

Keywords

AttachementOxytocinfMRI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

secure

EXPERIMENTAL

healthy adult male with secure attachement

Drug: nasal oxytocin or placeboDevice: fMRIBehavioral: Attachement scale interview (ASI)Behavioral: psychometric scales

avoidant

EXPERIMENTAL

healthy adult male with avoidant attachement

Drug: nasal oxytocin or placeboDevice: fMRIBehavioral: Attachement scale interview (ASI)Behavioral: psychometric scales

enmeshed/fearfull

EXPERIMENTAL

healthy adult male with enmeshed/fearfull attachement

Drug: nasal oxytocin or placeboDevice: fMRIBehavioral: Attachement scale interview (ASI)Behavioral: psychometric scales

dual style

EXPERIMENTAL

healthy adult male with dual attachement style

Drug: nasal oxytocin or placeboDevice: fMRIBehavioral: Attachement scale interview (ASI)Behavioral: psychometric scales

Interventions

nasal oxytocin or placeboDRUG

nasal administration of oxytocin or palcebo 45 min befor fMRI session

avoidantdual styleenmeshed/fearfullsecure
fMRIDEVICE

FMRI during emotional image visualization

avoidantdual styleenmeshed/fearfullsecure
Attachement scale interview (ASI)BEHAVIORAL

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

avoidantdual styleenmeshed/fearfullsecure
psychometric scalesBEHAVIORAL

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)

avoidantdual styleenmeshed/fearfullsecure

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • comprehension of french
  • having signed the informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon

Besançon, Doubs, 25030, France

Location

Related Publications (1)

  • Comte A, Szymanska M, Monnin J, Moulin T, Nezelof S, Magnin E, Jardri R, Vulliez-Coady L. Neural correlates of distress and comfort in individuals with avoidant, anxious and secure attachment style: an fMRI study. Attach Hum Dev. 2024 Oct;26(5):423-445. doi: 10.1080/14616734.2024.2384393. Epub 2024 Aug 2.

    PMID: 39093338RESULT

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Lauriane VULLIEZ-COADY, MD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

April 9, 2015

Primary Completion

April 27, 2018

Study Completion

April 27, 2018

Last Updated

October 2, 2024

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)