Ocytocine and Cerebral Activation in Relation With Attachement (OTACLA)

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 2

Conditions: Attachement Style

Treatments: Drug: nasal oxytocin or placebo; Behavioral: psychometric scales; Behavioral: Attachement scale interview (ASI); Device: fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02847143

P/2014/237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

secure

Experimental group

Description:

healthy adult male with secure attachement

Treatment:

Device: fMRI

Behavioral: Attachement scale interview (ASI)

Behavioral: psychometric scales

Drug: nasal oxytocin or placebo

avoidant

Experimental group

Description:

healthy adult male with avoidant attachement

Treatment:

Device: fMRI

Behavioral: Attachement scale interview (ASI)

Behavioral: psychometric scales

Drug: nasal oxytocin or placebo

enmeshed/fearfull

Experimental group

Description:

healthy adult male with enmeshed/fearfull attachement

Treatment:

Device: fMRI

Behavioral: Attachement scale interview (ASI)

Behavioral: psychometric scales

Drug: nasal oxytocin or placebo

dual style

Experimental group

Description:

healthy adult male with dual attachement style

Treatment:

Device: fMRI

Behavioral: Attachement scale interview (ASI)

Behavioral: psychometric scales

Drug: nasal oxytocin or placebo