Healthy VolunteersSERODOMNCT03041870
Relationship Between Serotonin and Brain Response to Social Dominance and Emotion Perception.
A study testing PET-fMRI scan in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PET-fMRI scan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2017to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- PET-fMRI scan
- Keywords
- PET-fMRI, dominance, 5HT transporter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dominance | Experimental | Healthy subjects Receives: Device: PET-fMRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at day 0
Secondary outcomes (4)
Behavioral assessment
During the entire scanner, subjects will be ask to perform a behavioral task. Their responses will be analyzed.
Measured: at day 0
Testosterone Blood level
The testosterone will be measured on a blood sample.
Measured: 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).
Measured: after the scan session at day 0
SLC6A4 genotyping
The genotyping of this gene (SLC6A4) will be realized on a sample of saliva.
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start14 Nov 2017
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian SCHEIBER, Principal investigator, Hospices Civils de Lyon - CNRS UMR 5229
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041870
- Sponsor's protocol ID
- 69HCL16_0014
- Other IDs
- 2016-A01588-43
- Acronym
- SERODOM
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Serotonin and Brain Response to Social Dominance Perception and Emotion: a Combined [11C]DASB-PET/fMRI Study in Humans
- ClinicalTrials.gov ID
- NCT03041870
- Acronym / sponsor ID
- SERODOM / 69HCL16_0014
- Conditions
- Healthy Volunteers
- Keywords
- PET-fMRI, dominance, 5HT transporter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dominance | Experimental | Device: PET-fMRI scanHealthy subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- French speaking
- Normal vision
- Age from 18 to 45
- Without psychiatric antecedent
- Without any neurologic antecedent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-fMRI scanfMRI 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. | Device | Dominance |
Primary outcome
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.
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.
4 secondary outcomes
Behavioral assessment
Time frame: at day 0
Testosterone Blood level
Time frame: after the scan session at day 0
Cortisol Blood level
Time frame: after the scan session at day 0
SLC6A4 genotyping
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian SCHEIBER principal investigator
Hospices Civils de Lyon - CNRS UMR 5229
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-fMRI scan in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of Blood-Oxygen-Level Dependent (BOLD) signal (time frame: at day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.