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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: PET-fMRI scan

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dominance; Healthy subjects	Device: PET-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at day 0
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.	at day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral assessment	During the entire scanner, subjects will be ask to perform a behavioral task. Their responses will be analyzed.	at day 0
Testosterone Blood level	The testosterone will be measured on a blood sample.	after the scan session at day 0
Cortisol Blood level	The cortisol will be measured on a blood sample (prelevated at same time than testosterone).	after the scan session at day 0
SLC6A4 genotyping	The genotyping of this gene (SLC6A4) will be realized on a sample of saliva.	at day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Christian SCHEIBER, Hospices Civils de Lyon - CNRS UMR 5229

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2017
• Primary Completion (ACTUAL): June 21, 2019
• Study Completion (ACTUAL): June 21, 2019

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (ESTIMATE): February 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: PET-fMRI; dominance; 5HT transporter
• Other Study ID Numbers: 69HCL16_0014; 2016-A01588-43 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No