HealthyRESEPTOR 5-HT7NCT05746845
Implication of 5-HT7 Receptor in Inflammatory Mechanisms in Multiple Sclerosis
An observational study of Healthy and Multiple Sclerosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Multiple Sclerosis is a chronic autoimmune disease associated with inflammatory response harmful for the Central Nervous System. Immunological imbalance is involved with Th1 and Th17 cells in correlation with a disturbance of regulators mechanisms as Treg cells. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Healthy, Multiple Sclerosis
- What is being tested?
- Blood sample
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2023to 1 Jul 2024
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment) Group 2: Stable MS patients without inflammatory activity of the disease under high efficacy treatment (Natalizumab or Ocrelizumab) Group 3: Stable MS patients without inflammatory disease activity under moderately effective treatment (Teriflunomide or Fumarate)
Who may be able to join
- Men and women
- Aged between 18 and 50 years old,
- With multiple sclerosis already diagnosed and fulfilling the modified Mc Donald criteria
- Stable (no relapse in the last 6 months and MRI less than a year old, with no new lesions) and with at least 1 year of treatment with Natalizumab, Ocrelizumab, Teriflunomide or Fumarate
- Subject medically fit to give a maximum of 50 ml of extra whole blood
- Patient having given their consent to participate in the study
Who cannot join
- HIV serology known or discovered during the present episode
- Demented patient
- Patient treated with corticosteroids in the last month
- Non-affiliated person or non-beneficiary of a social security scheme
- Uncooperative patient
- Patient under legal protection, guardianship or curatorship
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RESEPTOR 5-HT7 : Interest of the 5-HT7 Serotonin Receptor as a Biomarker in Multiple Sclerosis
Multiple Sclerosis is a chronic autoimmune disease associated with inflammatory response harmful for the Central Nervous System. Immunological imbalance is involved with Th1 and Th17 cells in correlation with a disturbance of regulators mechanisms as Treg cells. Despite years of research, the mechanisms involved remain unclear.
Serotonin (5-HT) seems to be play an essential role in developing CNS inflammatory diseases and in particular in MS. Indeed, several studies have shown the anti-inflammatory potential of this neurotransmitter and also its vulnerability in inflammatory context. Moreover, a recent study has shown that 5-HT can reduced CD4 T cells proliferation and pro-inflammatory cytokines released in vitro. Interestingly, treatment, treatment with SSRIs (selective serotonin reuptake inhibitor) in an animal model of MS, on Experimental Autoimmune Encephalomyelitis, was shown to improve the clinical score and promote remission of the disease.
Read more
Among serotonin receptors, the 5-HT7 receptor, can be considered as an interesting target to treat neurological disorders associated with inflammatory context. Present in humans and mice, this receptor is expressed on the surface of a large number of cells, such as T-lymphocytes, macrophages, dendritic cells as well as on cells of CNS such as neurons, astrocytes and microglia.
Given the importance of the positive cells for 5-HT7 receptor, in the inflammatory context observed in multiple sclerosis, the investigators propose to study the receptor expression in blood samples from multiple sclerosis patient.
Read the detailed description
In a previous translational study (5-HT SEP), the expression modulation of 5-HT7 receptor in function of immunological context was investigated, in different group of MS patients:
- Group 1: MS patients with an acute relapse
- Group 2: MS stable patients treated with Natalizumab
- Group 3: Healthy people (from Etablissement Français du Sang) From blood cells of different groups of individuals, the investigators determined the percentage and intensity of expression of the receptor on circulating lymphocytes by flow cytometry.
The investigators demonstrated in this first study that the 5-HT7 receptor is mainly expressed on the surface of B lymphocytes compared to T lymphocytes.
Interestingly, while the percentage of T lymphocytes (CD4+, CD8+) remained unchanged between the 3 groups, the investigators observed that the expression of R5-HT7 on the surface of the T lymphocyte subpopulations (Th1, Th2, Th17 and Treg), is significantly increased in the blood of MS patients treated with Natalizumab compared to healthy individuals and MS patients in relapse.
Considering litterature data and our preliminary results showing the therapeutic potential of 5-HT7R ligand in animal models of MS as well as the upregulation of 5-HT7 expression in NTZ-treated patients (5-HTSEP study), the investigators wish to go further with these investigations. The main objective of this new translational study is to demonstrate the interest of the 5-HT7 serotonin receptor as a biomarker in the therapeutic monitoring of patients suffering from Multiple Sclerosis.
The investigators first want to know if the increase in the expression of R5-HT7 on the surface of lymphocyte populations in stable MS patients is due specifically to Natalizumab treatment or if other treatments would also induce a similar effect. To answer this question, the investigators will study the expression of the receptor not only on the surface of lymphocyte cells but also on the surface of monocytes, NK cells and polymorphonuclear cells (cells not investigated in the first 5-HTSEP study) in three groups of individuals:
- Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment)
- Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab)
- Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate)
Group 1 (healthy volunteers) is a control group necessary for the smooth running of the study and the interpretation of the results.
For group 2, the Natalizumab treatment has already been investigated during the previous 5-HTSEP study. This new study will make it possible to 1) compare the expression/activity of the receptor in the three groups 2) check the reproducibility of the results compared to the previous study 3) evaluate any variations linked to the temporality of the treatment with 2 blood samples, a first before injection of Natalizumab, a second 14 days later. Indeed, unlike the 5-HTSEP study, where a single sample 1 month after injection of Natalizumab was analysed, the investigators wish to take these two samples, in order to carry out a longitudinal study making it possible to observe the evolution of the expression of the 5-HT7 receptor as a function of the temporality of the treatment.
Group 3 will assess whether other treatments (teriflunomide or fumarate) can induce an effect similar to that observed after Natalizumab treatment which is associated with an increase of R5-HT7 expression on the surface of lymphocyte populations in stable MS patients.
- Conditions
- Healthy, Multiple Sclerosis
- Being tested
- Blood sample
- Keywords
- Multiple sclerosis, Serotonin, 5-HT7 receptor, Inflammation, Lymphocytes, Monocytes, Cytokines
- Medical subject headings
- Multiple Sclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sampling will be done on three groups:
Group 1: Healthy volunteers, so-called "control" donors whose blood samples will be ordered from the EFS (French Blood Establishment) Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab) Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate)
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment) Receives: Biological: Blood sample | |
| Stable MS patients treated with high efficacy treatment | Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab) Receives: Biological: Blood sample | |
| Stable MS patients treated with moderately effective treatment | Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate) Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-HT7 receptor expression on circulating cells
using the flow cytometry technique, on whole blood, we will perform immunophenotyping in order to determine the fluorescence intensity of cells positive for the receptor (5-HT7+ cells) (B, T and NK lymphocytes, monocytes, and polynuclear cells) in the different groups of individuals.
Measured: Day 1
Secondary outcomes (5)
Expression of the 5-HT7 receptor after positive selection of different cell populations from PBMC
After Ficoll gradient, a part of PBMC (peripheral blood mononuclear cells) will be used to study the expression of the 5-HT7 receptor by positive selection of different cell populations (B lymphocytes, T lymphocytes, monocytes) using magnetic beads. Measurements of mRNA expression (R5-HT7, 5-HT synthesis enzyme, 5-HT transporter as well as markers of inflammation/autophagy) will be carried out by RT-qPCR.
Measured: Day 15
Expression of the different isoforms of the 5-HT7 receptor on PBMC
In humans, there are three isoforms, obtained by alternative splicing, of the receptor, 5-HT7a, 5-HT7b, 5-HT7d, which differ according to the length of their C-terminal part. To date, no differences between these isoforms from a pharmacological and transductional point have been described. However, it would be interesting to quantify them by RTqPCR using mRNA from total PBMCs and then mRNA from the main populations of PBMCs, obtained by magnetic sorting, in order to assess their proportion.
Measured: Day 15
Functional activity of the 5-HT7 receptor on PBMC: protein studies
A part of PBMCs (peripheral blood mononuclear cells) will be cultured and stimulated under different conditions: LPS stimulation (lipopolysaccharide), PHA stimulation (phytohemagglutinin), both stimulation LPS+PHA or with agonists and antagonists, as well as biased ligands of the receptor. After stimulation, cell supernatants will be collected in order to performed protein assays by ELISA technique (Enzyme-Linked Immunosorbent Assay). We want to measure the production of pro and anti-inflammatory cytokines (IL-1β, IL-4, TNFα, IL6, IL-17, IFN-γ and IL-10 and others based on literature data) to evaluate the effect of the different conditions of stimulation of PBMCs from the 3 group of patients
Measured: Day 15
Functional activity of the 5-HT7 receptor on PBMC: mRNA expression studies
A part of PBMCs (peripheral blood mononuclear cells) will be cultured and stimulated under different conditions: LPS stimulation (lipopolysaccharide), PHA stimulation (phytohemagglutinin), both stimulation LPS+PHA or with agonists and antagonists, as well as biased ligands of the receptor. After stimulation, mRNA expression measurements (R5-HT7, 5-HT synthesis enzyme, 5-HT transporter as well as markers of inflammation/autophagy) will be performed by qPCR.
Measured: Day 15
Relationship between Multiple sclerosis treatment on inflammation and serotonin production in serum
After Ficoll gradient, serum will be collected. Serotonin levels will be measured and different pro and anti-inflammatory mediators like IL-1β, IL-4, TNFα, IL6, IL8, IL-17, IFN-γ, GM-CSF and IL-10 and others based on literature data, will be investigated.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start6 Mar 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maud PALLIX-GUYOT, Dr, Principal investigator, CHU Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746845
- Sponsor's protocol ID
- CHRO-2021-07
- Acronym
- RESEPTOR 5-HT7
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sacramento PM, Monteiro C, Dias ASO, Kasahara TM, Ferreira TB, Hygino J, Wing AC, Andrade RM, Rueda F, Sales MC, Vasconcelos CC, Bento CAM. Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4+ T-cell subsets in multiple sclerosis patients. Eur J Immunol. 2018 Aug;48(8):1376-1388. doi: 10.1002/eji.201847525. Epub 2018 Jun 6.
PubMed 29719048Yuan XQ, Qiu G, Liu XJ, Liu S, Wu Y, Wang X, Lu T. Fluoxetine promotes remission in acute experimental autoimmune encephalomyelitis in rats. Neuroimmunomodulation. 2012;19(4):201-8. doi: 10.1159/000334095. Epub 2012 Mar 21.
PubMed 22441536
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESEPTOR 5-HT7 : Interest of the 5-HT7 Serotonin Receptor as a Biomarker in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05746845
- Acronym / sponsor ID
- RESEPTOR 5-HT7 / CHRO-2021-07
- Conditions
- Healthy, Multiple Sclerosis
- Keywords
- Multiple sclerosis, Serotonin, 5-HT7 receptor, Inflammation, Lymphocytes, Monocytes, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 Feb 2023 (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.
Multiple Sclerosis is a chronic autoimmune disease associated with inflammatory response harmful for the Central Nervous System. Immunological imbalance is involved with Th1 and Th17 cells in correlation with a disturbance of regulators mechanisms as Treg cells. Despite years of research, the mechanisms involved remain unclear.
Serotonin (5-HT) seems to be play an essential role in developing CNS inflammatory diseases and in particular in MS. Indeed, several studies have shown the anti-inflammatory potential of this neurotransmitter and also its vulnerability in inflammatory context. Moreover, a recent study has shown that 5-HT can reduced CD4 T cells proliferation and pro-inflammatory cytokines released in vitro. Interestingly, treatment, treatment with SSRIs (selective serotonin reuptake inhibitor) in an animal model of MS, on Experimental Autoimmune Encephalomyelitis, was shown to improve the clinical score and promote remission of the disease.
Among serotonin receptors, the 5-HT7 receptor, can be considered as an interesting target to treat neurological disorders associated with inflammatory context. Present in humans and mice, this receptor is expressed on the surface of a large number of cells, such as T-lymphocytes, macrophages, dendritic cells as well as on cells of CNS such as neurons, astrocytes and microglia.
Given the importance of the positive cells for 5-HT7 receptor, in the inflammatory context observed in multiple sclerosis, the investigators propose to study the receptor expression in blood samples from multiple sclerosis patient.
Detailed description
In a previous translational study (5-HT SEP), the expression modulation of 5-HT7 receptor in function of immunological context was investigated, in different group of MS patients:
- Group 1: MS patients with an acute relapse
- Group 2: MS stable patients treated with Natalizumab
- Group 3: Healthy people (from Etablissement Français du Sang) From blood cells of different groups of individuals, the investigators determined the percentage and intensity of expression of the receptor on circulating lymphocytes by flow cytometry.
The investigators demonstrated in this first study that the 5-HT7 receptor is mainly expressed on the surface of B lymphocytes compared to T lymphocytes.
Interestingly, while the percentage of T lymphocytes (CD4+, CD8+) remained unchanged between the 3 groups, the investigators observed that the expression of R5-HT7 on the surface of the T lymphocyte subpopulations (Th1, Th2, Th17 and Treg), is significantly increased in the blood of MS patients treated with Natalizumab compared to healthy individuals and MS patients in relapse.
Considering litterature data and our preliminary results showing the therapeutic potential of 5-HT7R ligand in animal models of MS as well as the upregulation of 5-HT7 expression in NTZ-treated patients (5-HTSEP study), the investigators wish to go further with these investigations. The main objective of this new translational study is to demonstrate the interest of the 5-HT7 serotonin receptor as a biomarker in the therapeutic monitoring of patients suffering from Multiple Sclerosis.
The investigators first want to know if the increase in the expression of R5-HT7 on the surface of lymphocyte populations in stable MS patients is due specifically to Natalizumab treatment or if other treatments would also induce a similar effect. To answer this question, the investigators will study the expression of the receptor not only on the surface of lymphocyte cells but also on the surface of monocytes, NK cells and polymorphonuclear cells (cells not investigated in the first 5-HTSEP study) in three groups of individuals:
- Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment)
- Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab)
- Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate)
Group 1 (healthy volunteers) is a control group necessary for the smooth running of the study and the interpretation of the results.
For group 2, the Natalizumab treatment has already been investigated during the previous 5-HTSEP study. This new study will make it possible to 1) compare the expression/activity of the receptor in the three groups 2) check the reproducibility of the results compared to the previous study 3) evaluate any variations linked to the temporality of the treatment with 2 blood samples, a first before injection of Natalizumab, a second 14 days later. Indeed, unlike the 5-HTSEP study, where a single sample 1 month after injection of Natalizumab was analysed, the investigators wish to take these two samples, in order to carry out a longitudinal study making it possible to observe the evolution of the expression of the 5-HT7 receptor as a function of the temporality of the treatment.
Group 3 will assess whether other treatments (teriflunomide or fumarate) can induce an effect similar to that observed after Natalizumab treatment which is associated with an increase of R5-HT7 expression on the surface of lymphocyte populations in stable MS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Biological: Blood sampleGroup 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment) |
| Stable MS patients treated with high efficacy treatment | – | Biological: Blood sampleGroup 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab) |
| Stable MS patients treated with moderately effective treatment | – | Biological: Blood sampleGroup 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment) Group 2: Stable MS patients without inflammatory activity of the disease under high efficacy treatment (Natalizumab or Ocrelizumab) Group 3: Stable MS patients without inflammatory disease activity under moderately effective treatment (Teriflunomide or Fumarate)
Key inclusion criteria (6 listed)
- Men and women
- Aged between 18 and 50 years old,
- With multiple sclerosis already diagnosed and fulfilling the modified Mc Donald criteria
- Stable (no relapse in the last 6 months and MRI less than a year old, with no new lesions) and with at least 1 year of treatment with Natalizumab, Ocrelizumab, Teriflunomide or Fumarate
- Subject medically fit to give a maximum of 50 ml of extra whole blood
Key exclusion criteria (7 listed)
- HIV serology known or discovered during the present episode
- Demented patient
- Patient treated with corticosteroids in the last month
- Non-affiliated person or non-beneficiary of a social security scheme
- Uncooperative patient
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 |
|---|---|---|
| Blood sampleBlood sampling will be done on three groups: Group 1: Healthy volunteers, so-called "control" donors whose blood samples will be ordered from the EFS (French Blood Establishment) Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab) Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate) | Biological | Healthy individuals, Stable MS patients treated with high efficacy treatment, Stable MS patients treated with moderately effective treatment |
Primary outcome
5-HT7 receptor expression on circulating cells
Time frame: Day 1
using the flow cytometry technique, on whole blood, we will perform immunophenotyping in order to determine the fluorescence intensity of cells positive for the receptor (5-HT7+ cells) (B, T and NK lymphocytes, monocytes, and polynuclear cells) in the different groups of individuals.
5 secondary outcomes
Expression of the 5-HT7 receptor after positive selection of different cell populations from PBMC
Time frame: Day 15
Expression of the different isoforms of the 5-HT7 receptor on PBMC
Time frame: Day 15
Functional activity of the 5-HT7 receptor on PBMC: protein studies
Time frame: Day 15
Functional activity of the 5-HT7 receptor on PBMC: mRNA expression studies
Time frame: Day 15
Relationship between Multiple sclerosis treatment on inflammation and serotonin production in serum
Time frame: Day 15
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 23 Dec 2025.
- Results publication: PubMed 29719048Sacramento PM, Monteiro C, Dias ASO, Kasahara TM, Ferreira TB, Hygino J, Wing AC, Andrade RM, Rueda F, Sales MC, Vasconcelos CC, Bento CAM. Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4+ T-cell subsets in multiple sclerosis patients. Eur J Immunol. 2018 Aug;48(8):1376-1388. doi: 10.1002/eji.201847525. Epub 2018 Jun 6.
- Results publication: PubMed 22441536Yuan XQ, Qiu G, Liu XJ, Liu S, Wu Y, Wang X, Lu T. Fluoxetine promotes remission in acute experimental autoimmune encephalomyelitis in rats. Neuroimmunomodulation. 2012;19(4):201-8. doi: 10.1159/000334095. Epub 2012 Mar 21.
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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.
Maud PALLIX-GUYOT, Dr principal investigator
CHU Orleans
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 Healthy and Multiple Sclerosis, run by Centre Hospitalier Régional d'Orléans 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 6 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 23 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?
5-HT7 receptor expression on circulating cells (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746845, which also lists 2 linked publications.
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 23 Dec 2025.