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OpenTrials
Completed

NCT Number: NCT06910774

Analysis of Peripheral Serotonin Levels in a Control Cohort

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91110

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dosage of serotonin and tryptophan metabolites levels in serum

Other

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.

Primary outcomes

  1. Serotonin

    Time frame: at day 0

    Measurement of serotonin levels in serum (HPLC: high performance liquid chromatography)

Secondary outcomes

  1. Tryptophan metabolites

    Time frame: at day 0

    Measurement of tryptophan metabolites levels in serum (HPLC: high performance liquid chromatography)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: ASPECT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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