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Ocytocine and Cerebral Activation in Relation With Attachement

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847143
Acronym
OTACLA
Enrollment
100
Registered
2016-07-28
Start date
2015-04-09
Completion date
2018-04-27
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attachement Style

Keywords

Attachement, Oxytocin, fMRI

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.

Interventions

DRUGnasal oxytocin or placebo

nasal administration of oxytocin or palcebo 45 min befor fMRI session

DEVICEfMRI

FMRI during emotional image visualization

BEHAVIORALAttachement scale interview (ASI)

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

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)

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BOLD signal intensity45 min after intranasal administration of oxytocin or placeboBOLD 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026