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Completed

NCT Number: NCT03041870

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

PET-fMRI scan

Device

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.

Primary outcomes

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

    Time frame: at day 0

    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.

  2. level of serotonin transporter

    Time frame: at day 0

    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.

Secondary outcomes

  1. Behavioral assessment

    Time frame: at day 0

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

  2. Testosterone Blood level

    Time frame: after the scan session at day 0

    The testosterone will be measured on a blood sample.

  3. Cortisol Blood level

    Time frame: after the scan session at day 0

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

  4. SLC6A4 genotyping

    Time frame: at day 0

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Relationship Between Serotonin and Brain Response to Social Dominance Perception and Emotion: a Combined [11C]DASB-PET/fMRI Study in Humans

Acronym: SERODOM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 3, 2017
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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