Attachement StylePhase 2OTACLANCT02847143
Ocytocine and Cerebral Activation in Relation With Attachement
A Phase 2 study testing fMRI, Attachement scale interview (ASI) and psychometric scales in people with Attachement Style, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Attachement Style
- What is being tested?
- fMRI, Attachement scale interview (ASI) and psychometric scales
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2015to 27 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- comprehension of french
- having signed the informed consent
Who cannot join
- chronic disease (liver failure, kidney failure) and cardiovascular disease
- hypertensive treatment
- treatment wich increases QT
- current hospitalisation
- fMRI contraindication
- legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Attachement Style
- Being tested
- nasal oxytocin or placebo, fMRI, Attachement scale interview (ASI), psychometric scales
- Keywords
- Attachement, Oxytocin, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal oxytocin or placeboDrug
nasal administration of oxytocin or palcebo 45 min befor fMRI session
fMRIDevice
FMRI during emotional image visualization
Attachement scale interview (ASI)Behavioural
this scale is used to determine the attachement style of each participant
psychometric scalesBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| secure | Experimental | healthy adult male with secure attachement Receives: Drug: nasal oxytocin or placebo; Device: fMRI; Behavioral: Attachement scale interview (ASI); Behavioral: psychometric scales |
| avoidant | Experimental | healthy adult male with avoidant attachement Receives: Drug: nasal oxytocin or placebo; Device: fMRI; Behavioral: Attachement scale interview (ASI); Behavioral: psychometric scales |
| enmeshed/fearfull | Experimental | healthy adult male with enmeshed/fearfull attachement Receives: Drug: nasal oxytocin or placebo; Device: fMRI; Behavioral: Attachement scale interview (ASI); Behavioral: psychometric scales |
| dual style | Experimental | healthy adult male with dual attachement style Receives: Drug: nasal oxytocin or placebo; Device: fMRI; Behavioral: Attachement scale interview (ASI); Behavioral: psychometric scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 min after intranasal administration of oxytocin or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start9 Apr 2015
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attachement StyleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauriane VULLIEZ-COADY, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847143
- Sponsor's protocol ID
- P/2014/237
- Acronym
- OTACLA
- Status last verified
- Jun 2021
- First submitted
- 25 Jul 2016
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39093338
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Over Randomized Controlled Trial of the Effect of Nasal Ocytocine on Cerebral Activations in Relation With Attachement in the General Population
- ClinicalTrials.gov ID
- NCT02847143
- Acronym / sponsor ID
- OTACLA / P/2014/237
- Conditions
- Attachement Style
- Keywords
- Attachement, Oxytocin, fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| secure | Experimental | Drug: nasal oxytocin or placebo, Device: fMRI, Behavioral: Attachement scale interview (ASI), Behavioral: psychometric scaleshealthy adult male with secure attachement |
| avoidant | Experimental | Drug: nasal oxytocin or placebo, Device: fMRI, Behavioral: Attachement scale interview (ASI), Behavioral: psychometric scaleshealthy adult male with avoidant attachement |
| enmeshed/fearfull | Experimental | Drug: nasal oxytocin or placebo, Device: fMRI, Behavioral: Attachement scale interview (ASI), Behavioral: psychometric scaleshealthy adult male with enmeshed/fearfull attachement |
| dual style | Experimental | Drug: nasal oxytocin or placebo, Device: fMRI, Behavioral: Attachement scale interview (ASI), Behavioral: psychometric scaleshealthy adult male with dual attachement style |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- comprehension of french
- having signed the informed consent
Key exclusion criteria (6 listed)
- chronic disease (liver failure, kidney failure) and cardiovascular disease
- hypertensive treatment
- treatment wich increases QT
- current hospitalisation
- fMRI contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal oxytocin or placebonasal administration of oxytocin or palcebo 45 min befor fMRI session | Drug | avoidant, dual style, enmeshed/fearfull, secure |
| fMRIFMRI during emotional image visualization | Device | avoidant, dual style, enmeshed/fearfull, secure |
| Attachement scale interview (ASI)this scale is used to determine the attachement style of each participant | Behavioural | avoidant, dual style, enmeshed/fearfull, secure |
| psychometric scalesself 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) | Behavioural | avoidant, dual style, enmeshed/fearfull, secure |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Results publication: PubMed 39093338Comte 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.
- Individual participant dataSharing planned: No
Related trials for Attachement Style
Recruiting
Does Attachment Anxiety Moderate the Influence of Social Rejection on Alcohol Use Among Young Adults?
Social Rejection, Attachement Style
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauriane VULLIEZ-COADY, MD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fMRI, Attachement scale interview (ASI) and psychometric scales in people with Attachement Style, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal intensity (time frame: 45 min after intranasal administration of oxytocin or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.