CClinicalTrials.gg
CompletedNCT03041870SERODOMUpdated Jul 16, 2019

Relationship Between Serotonin and Brain Response to Social Dominance and Emotion Perception.

An interventional study of PET-fMRI scan in Healthy Volunteers, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
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Study summary

Previous studies have already revealed the involvement of the serotoninergic system in the social behavior process. For example, more serotonin (5HT) was found in dominant male adult monkeys. Little is known about the serotoninergic implication in human's social behavior. The project aims to clarify the role of the serotoninergic system in social behavior in relation to the process of social hierarchical information. In order to determine how serotoninergic system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us to measure the brain activity and the serotoninergic transporter occupancy (using the [C11]-DASB) at the same time. The current study aims to investigate whether serotonin transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection of social dominance in facial expressions or other measures of social information processing. Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and neuropsychological questionnaires will give at the investigator more information and allow to investigate whether performance on social information processing is modulated by personality trait and genotype.

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Conditions studied

  • Healthy Volunteers

Keywords

  • PET-fMRI
  • dominance
  • 5HT transporter
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In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • French speaking
  • Normal vision
  • Age from 18 to 45
  • Without psychiatric antecedent
  • Without any neurologic antecedent
  • Not taking psychotropic or anxiolytic drugs
  • Having health insurance coverage

Exclusion criteria

Exclusion Criteria:

  • The subject does not wish to be notified of any anomalies detected during MRI
  • Subjects suffering from claustrophobia
  • Subjects carrying magnetic metal objects that cannot be removed as cochlear implant, surgical clips, piercings, pacemakers, mechanical valves
  • Subjects participating in a clinical trial or being in a period of exclusion from a previous clinical trial
  • Person under guardianship or curatorship or deprived of liberty or in emergencies
  • Taking unauthorized treatment in the month before the completion of the review
  • Person whose physical or mental condition does not allow him to pass the test study
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Dominance

    Healthy subjects

    Device: PET-fMRI scan

Interventions

  • DevicePET-fMRI scan

    fMRI scan include MR sequences: BOLD and fMRI. The PET acquisition will be carried out in dynamic for 90 consecutive minutes following intravenous administration of 4 MBq / kg dose of \[11C\]DASB bolus.

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What researchers measure

Primary outcomes

  1. level of Blood-Oxygen-Level Dependent (BOLD) signal

    The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with \[11C\]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of \[11C\]DASB bonded to the transporter. Our reference region will be the cerebellum.

    Time frame: at day 0

  2. level of serotonin transporter

    The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with \[11C\]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of \[11C\]DASB bonded to the transporter. Our reference region will be the cerebellum.

    Time frame: at day 0

Secondary outcomes

  1. Behavioral assessment

    During the entire scanner, subjects will be ask to perform a behavioral task. Their responses will be analyzed.

    Time frame: at day 0

  2. Testosterone Blood level

    The testosterone will be measured on a blood sample.

    Time frame: after the scan session at day 0

  3. Cortisol Blood level

    The cortisol will be measured on a blood sample (prelevated at same time than testosterone).

    Time frame: after the scan session at day 0

  4. SLC6A4 genotyping

    The genotyping of this gene (SLC6A4) will be realized on a sample of saliva.

    Time frame: at day 0

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Study locations

1 site
  • Hospices Civils de Lyon
    Bron, 69500, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03041870
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 3, 2017
Start date
Nov 14, 2017
Primary completion
Jun 21, 2019
Completion
Jun 21, 2019
Last update
Jul 16, 2019

Study contacts

Christian SCHEIBER
principal investigator · Hospices Civils de Lyon - CNRS UMR 5229

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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