NCT03041870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 14, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

January 31, 2017

Last Update Submit

July 15, 2019

Conditions

Healthy Volunteers

Keywords

PET-fMRIdominance5HT transporter

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Behavioral assessment

    at day 0

  • Testosterone Blood level

    after the scan session at day 0

  • Cortisol Blood level

    after the scan session at day 0

  • SLC6A4 genotyping

    at day 0

Study Arms (1)

Dominance

EXPERIMENTAL

Healthy subjects

Device: PET-fMRI scan

Interventions

PET-fMRI scanDEVICE

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.

Dominance

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Study Officials

  • Christian SCHEIBER

    Hospices Civils de Lyon - CNRS UMR 5229

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 3, 2017

Study Start

November 14, 2017

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)