No Condition : to Establish Reference Serum Serotonin Levels in a Control CohortASPECTNCT06910774
Analysis of Peripheral Serotonin Levels in a Control Cohort
An observational study of No Condition : to Establish Reference Serum Serotonin Levels in a Control Cohort, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The goal of this observational study is to measure serotonin levels in in a control cohort. The main question aims to determine the mean serum serotonin level in a cohort of adult controls, based on age and sex. This will allow for the establishment of reference values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Condition : to Establish Reference Serum Serotonin Levels in a Control Cohort
- What is being tested?
- Dosage of serotonin and tryptophan metabolites levels in serum
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2025to 16 Nov 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is a control cohort. We will include adult patients aged 18 years or older who have undergone a blood draw at CHSF during the recruitment period. Eligible participants must have hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges, and a C-reactive protein (CRP) level below 30 mg/L.
Who may be able to join
- Adult patients aged ≥ 18 years
- Who have undergone a blood draw at CHSF during the recruitment period
- With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges
- With a C-reactive protein (CRP) level < 30 mg/L
Who cannot join
- Patients informed about the study who decline participation
- Patients with a current diagnosis or history of psychiatric disorders
- Patients on antidepressants or narcotics at the time of sampling
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to measure serotonin levels in in a control cohort.
The main question aims to determine the mean serum serotonin level in a cohort of adult controls, based on age and sex.
This will allow for the establishment of reference values. We will also measure the different metabolites of tryptophan. These measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Thus, patients will not need to undergo an additional blood draw.
Read the detailed description
Serotonin (5-HT or 5-hydroxytryptamine) is a monoamine primarily recognized for its role as a neurotransmitter in the central nervous system (CNS). It is synthesized from tryptophan, which is also essential for the production of metabolites in the kynurenine and indole families.
However, serotonin's functions extend beyond the CNS: various peripheral tissues have the capacity to produce and/or utilize serotonin locally, forming systems referred to as "micro-serotonergic." Among serotonin's peripheral roles, it has been demonstrated to positively influence erythropoiesis and red blood cell survival, iron metabolism, skin pigmentation, as well as placental and embryonic development during pregnancy.
In humans, there is no established standard for blood serotonin levels. It is known that, aside from major events, an individual's serotonin levels remain stable throughout life, but it is likely that blood serotonin levels depend on age and sex.
We aim to establish a cohort of adult control patients, for whom we will measure serum serotonin and the different metabolites of tryptophan, to analyze whether serotonin varies according to sex and age, and to determine its average serum levels.
Preliminary data from the laboratory suggest a role for serotonin in iron metabolism. Therefore, as a secondary objective, we also intend to perform an iron status assessment in control patients to analyze whether there are variations in iron parameters based on serotonin levels.
This cohort could also serve as a comparison point for future studies of serum serotonin levels in pathological conditions or during pregnancy.
- Being tested
- Dosage of serotonin and tryptophan metabolites levels in serum
- Keywords
- serotonin (5-HT), tryptophan, control cohort, age, sex, iron status
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of serotonin and tryptophan metabolites levels in serumOther
These measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Patients will not need to undergo an additional blood draw.
| Study group | Role | What they receive |
|---|---|---|
| control cohort | * Adult patients aged ≥ 18 years
* Who have undergone a blood draw at CHSF during the recruitment period
* With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges
* With a C-reactive protein (CRP) level < 30 mg/L Receives: Other: Dosage of serotonin and tryptophan metabolites levels in serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotonin
Measurement of serotonin levels in serum (HPLC: high performance liquid chromatography)
Measured: at day 0
Secondary outcomes (1)
Tryptophan metabolites
Measurement of tryptophan metabolites levels in serum (HPLC: high performance liquid chromatography)
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 posted4 Apr 2025
- Study start23 Jun 2025
- Primary completion16 Nov 2025
- Study completion16 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition : to Establish Reference Serum Serotonin Levels in a Control CohortStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillemette FOUQUET, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910774
- Sponsor's protocol ID
- 2024/0033
- Acronym
- ASPECT
- Status last verified
- Dec 2025
- First submitted
- 28 Mar 2025
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Peripheral Serotonin Levels in a Control Cohort
- ClinicalTrials.gov ID
- NCT06910774
- Acronym / sponsor ID
- ASPECT / 2024/0033
- Keywords
- serotonin (5-HT), tryptophan, control cohort, age, sex, iron status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 16 Nov 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- 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.
The goal of this observational study is to measure serotonin levels in in a control cohort.
The main question aims to determine the mean serum serotonin level in a cohort of adult controls, based on age and sex.
This will allow for the establishment of reference values. We will also measure the different metabolites of tryptophan. These measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Thus, patients will not need to undergo an additional blood draw.
Detailed description
Serotonin (5-HT or 5-hydroxytryptamine) is a monoamine primarily recognized for its role as a neurotransmitter in the central nervous system (CNS). It is synthesized from tryptophan, which is also essential for the production of metabolites in the kynurenine and indole families.
However, serotonin's functions extend beyond the CNS: various peripheral tissues have the capacity to produce and/or utilize serotonin locally, forming systems referred to as "micro-serotonergic." Among serotonin's peripheral roles, it has been demonstrated to positively influence erythropoiesis and red blood cell survival, iron metabolism, skin pigmentation, as well as placental and embryonic development during pregnancy.
In humans, there is no established standard for blood serotonin levels. It is known that, aside from major events, an individual's serotonin levels remain stable throughout life, but it is likely that blood serotonin levels depend on age and sex.
We aim to establish a cohort of adult control patients, for whom we will measure serum serotonin and the different metabolites of tryptophan, to analyze whether serotonin varies according to sex and age, and to determine its average serum levels.
Preliminary data from the laboratory suggest a role for serotonin in iron metabolism. Therefore, as a secondary objective, we also intend to perform an iron status assessment in control patients to analyze whether there are variations in iron parameters based on serotonin levels.
This cohort could also serve as a comparison point for future studies of serum serotonin levels in pathological conditions or during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control cohort | – | Other: Dosage of serotonin and tryptophan metabolites levels in serum* Adult patients aged ≥ 18 years * Who have undergone a blood draw at CHSF during the recruitment period * With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges * With a C-reactive protein (CRP) level < 30 mg/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a control cohort. We will include adult patients aged 18 years or older who have undergone a blood draw at CHSF during the recruitment period. Eligible participants must have hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges, and a C-reactive protein (CRP) level below 30 mg/L.
Key inclusion criteria (4 listed)
- Adult patients aged ≥ 18 years
- Who have undergone a blood draw at CHSF during the recruitment period
- With hemoglobin, white blood cell, and platelet counts within the laboratory's normal ranges
- With a C-reactive protein (CRP) level < 30 mg/L
Key exclusion criteria (3 listed)
- Patients informed about the study who decline participation
- Patients with a current diagnosis or history of psychiatric disorders
- Patients on antidepressants or narcotics at the time of sampling
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 |
|---|---|---|
| Dosage of serotonin and tryptophan metabolites levels in serumThese measurements will be performed on residual blood samples in the laboratory, after blood collection carried out as part of routine care. Patients will not need to undergo an additional blood draw. | Other | control cohort |
Primary outcome
Serotonin
Time frame: at day 0
Measurement of serotonin levels in serum (HPLC: high performance liquid chromatography)
1 secondary outcome
Tryptophan metabolites
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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.
Guillemette FOUQUET, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Condition : to Establish Reference Serum Serotonin Levels in a Control Cohort, run by Centre Hospitalier Sud Francilien 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 4 inclusion and 3 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 30 Dec 2025. 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?
Serotonin (time frame: at day 0). 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 30 Dec 2025.