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

Healthy Volunteers Clinical Trial

— SERODOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041870
• Other study ID #: 69HCL16_0014
• Secondary ID: 2016-A01588-43
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: June 21, 2019

Study information

• Verified date: July 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Behavioral assessment	During the entire scanner, subjects will be ask to perform a behavioral task. Their responses will be analyzed.	at day 0
Secondary	Testosterone Blood level	The testosterone will be measured on a blood sample.	after the scan session at day 0
Secondary	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
Secondary	SLC6A4 genotyping	The genotyping of this gene (SLC6A4) will be realized on a sample of saliva.	at day 0