Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041870
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: PET-fMRI scan Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Relationship Between Serotonin and Brain Response to Social Dominance Perception and Emotion: a Combined [11C]DASB-PET/fMRI Study in Humans
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041870


Locations
Layout table for location information
France
Hospices Civils de Lyon
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Christian SCHEIBER Hospices Civils de Lyon - CNRS UMR 5229
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03041870    
Other Study ID Numbers: 69HCL16_0014
2016-A01588-43 ( Other Identifier: ID-RCB )
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
PET-fMRI
dominance
5HT transporter