Bipolar Affective DisordersSPERLICNCT07785167
Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder
An observational study of Bipolar Affective Disorders, run by University of Catania at 1 site in Italy.
Trial summary
This observational study investigates the expression profile of chemokine receptors and adhesion molecules in CD8+ T lymphocytes from individuals with Bipolar Disorder compared with healthy controls. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Affective Disorders
- What is being tested?
- CD8+ T-Cell Gene Expression Analysis
- How many people
- 172 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2026to 7 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will include adults aged 25 to 35 years with Bipolar I or Bipolar II Disorder and healthy controls. Participants with Bipolar Disorder will be recruited among patients receiving inpatient, Day-Service, or Day-Hospital care at the Psychiatry Unit of the University Hospital "G. Rodolico-San Marco" in Catania, Italy, as part of routine clinical practice. Eligible patients must be drug-naive or have been free from psychopharmacological treatment for at least 6 months. Healthy controls will be recruited from volunteers from the university/hospital community or the general community and must have no clinical evidence of Bipolar Disorder and no current psychotropic treatment. All participants will provide written informed consent before enrollment.
Who may be able to join
- Participants with Bipolar Disorder:
- Age 25 to 35 years.
- Male or female; female participants must be in the mid-luteal phase of the menstrual cycle.
- Clinical presentation consistent with a diagnosis of Bipolar I Disorder or Bipolar II Disorder.
- First diagnosis of Bipolar Disorder with no previous psychopharmacological treatment (drug-naive), or absence of psychopharmacological treatment for at least 6 months (drug-free).
- Ability and willingness to provide written informed consent.
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- Healthy Controls Group:
- Age 25 to 35 years.
- Male or female; female participants must be in the mid-luteal phase of the menstrual cycle.
- No current treatment with psychotropic medications.
- No clinical or symptomatic evidence supporting a diagnosis of Bipolar I Disorder or Bipolar II Disorder.
- Hamilton Depression Rating Scale (HAM-D) score <8.
- Mania Rating Scale (MRS) score <11.
- No major stressful life events during the previous 6 months, such as bereavement, traumatic events, or divorce.
- Ability and willingness to provide written informed consent.
Who cannot join
- Current treatment with corticosteroids, immunosuppressive agents, antibiotics, or hormone replacement therapy.
- Relevant current medical comorbidities, including autoimmune diseases or other clinically significant internal medicine conditions.
- Relevant psychiatric comorbidities.
- Current psychopharmacological treatment or psychopharmacological treatment discontinued less than 6 months before enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Professor Carmen Concerto, PhD, MD contact
Italy1 site
Psychiatry Unit, Policlinico "G.Rodolico" Hospital, Via Santa Sofia 78
Catania, Sicily, 95123
Professor Maria Salvina Signorelli, MD, PhD, +39 095 3782791, maria.signorelli@unict.it
Professor Carmen Concerto, MD, PhD
About this study
Official title: Characterization of Chemokine Receptor Expression in CD8+ T Lymphocytes in Bipolar Disorder
This observational study investigates the expression profile of chemokine receptors and adhesion molecules in CD8+ T lymphocytes from individuals with Bipolar Disorder compared with healthy controls. The study focuses on CCR5 and CXCR3, which are involved in CD8+ T-cell migration toward the central nervous system, as well as the adhesion-related molecules PSGL-1, VLA-4, and LFA-1. Participants with Bipolar I or Bipolar II Disorder will be drug-naive or drug-free for at least 6 months and will be compared with healthy controls. Differences in molecular expression will also be explored according to the current mood episode, including depressive and manic/hypomanic phases. Gene expression will be assessed by real-time PCR in purified CD8+ T lymphocytes obtained from peripheral blood samples.
Read the detailed description
Bipolar Disorder (BD) is a chronic mood disorder whose underlying biological mechanisms remain incompletely understood. Increasing evidence suggests that immune dysregulation may contribute to its pathophysiology. In particular, alterations involving T lymphocytes and the migration of CD8+ T cells toward the central nervous system have been proposed as potentially relevant mechanisms. Similar immune-cell trafficking mechanisms are well characterized in multiple sclerosis, where chemokine receptors and leukocyte adhesion molecules contribute to lymphocyte recruitment and migration across the vascular endothelium.
The aim of the SPERLIC study is to characterize the expression profile of molecules involved in CD8+ T-cell trafficking in individuals with Bipolar Disorder and to compare these profiles with those observed in healthy controls. The study will primarily investigate the chemokine receptors CCR5 and CXCR3, which are involved in CD8+ T-cell recruitment toward the central nervous system. Expression of the adhesion-related molecules PSGL-1, VLA-4, and LFA-1 will also be evaluated. Secondary analyses will investigate possible differences in the expression of CCR5, CXCR3, PSGL-1, VLA-4, and LFA-1 according to the current mood phase, comparing patients experiencing a depressive episode with those experiencing a manic or hypomanic episode.
The study will include individuals aged 25 to 35 years with a diagnosis of Bipolar I or Bipolar II Disorder who are either drug-naive or have been free from psychopharmacological treatment for at least 6 months, together with a group of healthy controls. Patients will be recruited among individuals receiving care at the Psychiatry Unit of the University Hospital "G. Rodolico-San Marco" in Catania, Italy. Healthy controls will be recruited among volunteers without clinical evidence of Bipolar Disorder and without current psychotropic treatment. Clinical characterization will include demographic and clinical variables and standardized psychopathological assessments, including the Hamilton Depression Rating Scale, Mania Rating Scale, and SCL-90.
Peripheral blood samples will be used to isolate peripheral blood mononuclear cells by density-gradient centrifugation. CD8+ T lymphocytes will subsequently be purified using magnetic cell separation. Total RNA will be extracted from purified CD8+ T cells, and the relative mRNA expression of CCR5, CXCR3, PSGL-1, VLA-4, and LFA-1 will be quantified using SYBR-based one-step real-time PCR.
The planned sample comprises 172 participants, equally distributed between individuals with Bipolar Disorder and healthy controls. The sample size was estimated assuming an independent two-sided t-test, an effect size of 0.5, an alpha level of 0.05, and a statistical power of 0.90. Relative gene-expression differences will be calculated using the 2^-ΔΔCt method, and ΔCt values will be used for between-group statistical comparisons.
- Conditions
- Bipolar Affective Disorders
- Being tested
- CD8+ T-Cell Gene Expression Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD8+ T-Cell Gene Expression AnalysisOther
Peripheral blood mononuclear cells will be isolated from peripheral blood by density-gradient centrifugation, followed by purification of CD8+ T lymphocytes using magnetic cell separation. Total RNA will be extracted from purified CD8+ T cells. Relative mRNA expression of CCR5, CXCR3, PSGL-1, VLA-4, and LFA-1 will be assessed using SYBR-based one-step real-time PCR.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder Group | Participants aged 25-35 years with a diagnosis of Bipolar I or Bipolar II Disorder who are either drug-naive or have been free from psychopharmacological treatment for at least 6 months. Participants will be characterized according to the current mood phase, including depressive and manic/hypomanic episodes. Receives: Other: CD8+ T-Cell Gene Expression Analysis | |
| Healthy Control Group | Healthy volunteers aged 25-35 years without clinical evidence of Bipolar I or Bipolar II Disorder and not receiving psychotropic medications. Eligible controls must have a Hamilton Depression Rating Scale score <8 and a Mania Rating Scale score <11. Receives: Other: CD8+ T-Cell Gene Expression Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative mRNA Expression of CCR5 in CD8+ T Lymphocytes
Relative CCR5 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. CCR5 expression will be compared between participants with Bipolar Disorder and healthy controls.
Measured: At baseline (single study visit)
Relative mRNA Expression of CXCR3 in CD8+ T Lymphocytes
Relative CXCR3 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. CXCR3 expression will be compared between participants with Bipolar Disorder and healthy controls.
Measured: At baseline (single study visit)
Secondary outcomes (3)
Relative mRNA Expression of PSGL-1 in CD8+ T Lymphocytes
Relative PSGL-1 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. PSGL-1 expression will be compared between participants with Bipolar Disorder and healthy controls.
Measured: At baseline (single study visit)
Relative mRNA Expression of VLA-4 in CD8+ T Lymphocytes
Relative VLA-4 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. VLA-4 expression will be compared between participants with Bipolar Disorder and healthy controls.
Measured: At baseline (single study visit)
Relative mRNA Expression of LFA-1 in CD8+ T Lymphocytes
Relative LFA-1 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. LFA-1 expression will be compared between participants with Bipolar Disorder and healthy controls.
Measured: At baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completion7 Sep 2028 (estimated)
- Study completion7 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar Affective DisordersStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Concerto, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785167
- Sponsor's protocol ID
- 09/2026/CL-PAR
- Acronym
- SPERLIC
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Publications
Magioncalda P, Martino M. A unified model of the pathophysiology of bipolar disorder. Mol Psychiatry. 2022 Jan;27(1):202-211. doi: 10.1038/s41380-021-01091-4. Epub 2021 Apr 15.
PubMed 33859358Magioncalda P, Martino M, Tardito S, Sterlini B, Conio B, Marozzi V, Adavastro G, Capobianco L, Russo D, Parodi A, Kalli F, Nasi G, Altosole T, Piaggio N, Northoff G, Fenoglio D, Inglese M, Filaci G, Amore M. White matter microstructure alterations correlate with terminally differentiated CD8+ effector T cell depletion in the peripheral blood in mania: Combined DTI and immunological investigation in the different phases of bipolar disorder. Brain Behav Immun. 2018 Oct;73:192-204. doi: 10.1016/j.bbi.2018.04.017. Epub 2018 May 1.
PubMed 29723656Barbosa IG, Rocha NP, Assis F, Vieira EL, Soares JC, Bauer ME, Teixeira AL. Monocyte and lymphocyte activation in bipolar disorder: a new piece in the puzzle of immune dysfunction in mood disorders. Int J Neuropsychopharmacol. 2014 Oct 31;18(1):pyu021. doi: 10.1093/ijnp/pyu021.
PubMed 25539506Harrison PJ, Geddes JR, Tunbridge EM. The Emerging Neurobiology of Bipolar Disorder. Trends Neurosci. 2018 Jan;41(1):18-30. doi: 10.1016/j.tins.2017.10.006. Epub 2017 Nov 20.
PubMed 29169634
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Chemokine Receptor Expression in CD8+ T Lymphocytes in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07785167
- Acronym / sponsor ID
- SPERLIC / 09/2026/CL-PAR
- Conditions
- Bipolar Affective Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 7 Sep 2028 (estimated)
- Study completion
- 7 Sep 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
This observational study investigates the expression profile of chemokine receptors and adhesion molecules in CD8+ T lymphocytes from individuals with Bipolar Disorder compared with healthy controls. The study focuses on CCR5 and CXCR3, which are involved in CD8+ T-cell migration toward the central nervous system, as well as the adhesion-related molecules PSGL-1, VLA-4, and LFA-1. Participants with Bipolar I or Bipolar II Disorder will be drug-naive or drug-free for at least 6 months and will be compared with healthy controls. Differences in molecular expression will also be explored according to the current mood episode, including depressive and manic/hypomanic phases. Gene expression will be assessed by real-time PCR in purified CD8+ T lymphocytes obtained from peripheral blood samples.
Detailed description
Bipolar Disorder (BD) is a chronic mood disorder whose underlying biological mechanisms remain incompletely understood. Increasing evidence suggests that immune dysregulation may contribute to its pathophysiology. In particular, alterations involving T lymphocytes and the migration of CD8+ T cells toward the central nervous system have been proposed as potentially relevant mechanisms. Similar immune-cell trafficking mechanisms are well characterized in multiple sclerosis, where chemokine receptors and leukocyte adhesion molecules contribute to lymphocyte recruitment and migration across the vascular endothelium.
The aim of the SPERLIC study is to characterize the expression profile of molecules involved in CD8+ T-cell trafficking in individuals with Bipolar Disorder and to compare these profiles with those observed in healthy controls. The study will primarily investigate the chemokine receptors CCR5 and CXCR3, which are involved in CD8+ T-cell recruitment toward the central nervous system. Expression of the adhesion-related molecules PSGL-1, VLA-4, and LFA-1 will also be evaluated. Secondary analyses will investigate possible differences in the expression of CCR5, CXCR3, PSGL-1, VLA-4, and LFA-1 according to the current mood phase, comparing patients experiencing a depressive episode with those experiencing a manic or hypomanic episode.
The study will include individuals aged 25 to 35 years with a diagnosis of Bipolar I or Bipolar II Disorder who are either drug-naive or have been free from psychopharmacological treatment for at least 6 months, together with a group of healthy controls. Patients will be recruited among individuals receiving care at the Psychiatry Unit of the University Hospital "G. Rodolico-San Marco" in Catania, Italy. Healthy controls will be recruited among volunteers without clinical evidence of Bipolar Disorder and without current psychotropic treatment. Clinical characterization will include demographic and clinical variables and standardized psychopathological assessments, including the Hamilton Depression Rating Scale, Mania Rating Scale, and SCL-90.
Peripheral blood samples will be used to isolate peripheral blood mononuclear cells by density-gradient centrifugation. CD8+ T lymphocytes will subsequently be purified using magnetic cell separation. Total RNA will be extracted from purified CD8+ T cells, and the relative mRNA expression of CCR5, CXCR3, PSGL-1, VLA-4, and LFA-1 will be quantified using SYBR-based one-step real-time PCR.
The planned sample comprises 172 participants, equally distributed between individuals with Bipolar Disorder and healthy controls. The sample size was estimated assuming an independent two-sided t-test, an effect size of 0.5, an alpha level of 0.05, and a statistical power of 0.90. Relative gene-expression differences will be calculated using the 2^-ΔΔCt method, and ΔCt values will be used for between-group statistical comparisons.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder Group | – | Other: CD8+ T-Cell Gene Expression AnalysisParticipants aged 25-35 years with a diagnosis of Bipolar I or Bipolar II Disorder who are either drug-naive or have been free from psychopharmacological treatment for at least 6 months. Participants will be characterized according to the current mood phase, including depressive and manic/hypomanic episodes. |
| Healthy Control Group | – | Other: CD8+ T-Cell Gene Expression AnalysisHealthy volunteers aged 25-35 years without clinical evidence of Bipolar I or Bipolar II Disorder and not receiving psychotropic medications. Eligible controls must have a Hamilton Depression Rating Scale score <8 and a Mania Rating Scale score <11. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include adults aged 25 to 35 years with Bipolar I or Bipolar II Disorder and healthy controls. Participants with Bipolar Disorder will be recruited among patients receiving inpatient, Day-Service, or Day-Hospital care at the Psychiatry Unit of the University Hospital "G. Rodolico-San Marco" in Catania, Italy, as part of routine clinical practice. Eligible patients must be drug-naive or have been free from psychopharmacological treatment for at least 6 months. Healthy controls will be recruited from volunteers from the university/hospital community or the general community and must have no clinical evidence of Bipolar Disorder and no current psychotropic treatment. All participants will provide written informed consent before enrollment.
Key inclusion criteria (15 listed)
- Participants with Bipolar Disorder:
- Healthy Controls Group:
Key exclusion criteria (4 listed)
- Current treatment with corticosteroids, immunosuppressive agents, antibiotics, or hormone replacement therapy.
- Relevant current medical comorbidities, including autoimmune diseases or other clinically significant internal medicine conditions.
- Relevant psychiatric comorbidities.
- Current psychopharmacological treatment or psychopharmacological treatment discontinued less than 6 months before enrollment.
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 |
|---|---|---|
| CD8+ T-Cell Gene Expression AnalysisPeripheral blood mononuclear cells will be isolated from peripheral blood by density-gradient centrifugation, followed by purification of CD8+ T lymphocytes using magnetic cell separation. Total RNA will be extracted from purified CD8+ T cells. Relative mRNA expression of CCR5, CXCR3, PSGL-1, VLA-4, and LFA-1 will be assessed using SYBR-based one-step real-time PCR. | Other | Bipolar Disorder Group, Healthy Control Group |
Primary outcome
Relative mRNA Expression of CCR5 in CD8+ T Lymphocytes
Time frame: At baseline (single study visit)
Relative CCR5 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. CCR5 expression will be compared between participants with Bipolar Disorder and healthy controls.
Relative mRNA Expression of CXCR3 in CD8+ T Lymphocytes
Time frame: At baseline (single study visit)
Relative CXCR3 mRNA expression in purified peripheral blood CD8+ T lymphocytes will be quantified by SYBR-based one-step real-time PCR. Gene expression will be normalized to the reference gene and expressed as relative fold change using the 2^-ΔΔCt method. CXCR3 expression will be compared between participants with Bipolar Disorder and healthy controls.
3 secondary outcomes
Relative mRNA Expression of PSGL-1 in CD8+ T Lymphocytes
Time frame: At baseline (single study visit)
Relative mRNA Expression of VLA-4 in CD8+ T Lymphocytes
Time frame: At baseline (single study visit)
Relative mRNA Expression of LFA-1 in CD8+ T Lymphocytes
Time frame: At baseline (single study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 33859358Magioncalda P, Martino M. A unified model of the pathophysiology of bipolar disorder. Mol Psychiatry. 2022 Jan;27(1):202-211. doi: 10.1038/s41380-021-01091-4. Epub 2021 Apr 15.
- Background: PubMed 29723656Magioncalda P, Martino M, Tardito S, Sterlini B, Conio B, Marozzi V, Adavastro G, Capobianco L, Russo D, Parodi A, Kalli F, Nasi G, Altosole T, Piaggio N, Northoff G, Fenoglio D, Inglese M, Filaci G, Amore M. White matter microstructure alterations correlate with terminally differentiated CD8+ effector T cell depletion in the peripheral blood in mania: Combined DTI and immunological investigation in the different phases of bipolar disorder. Brain Behav Immun. 2018 Oct;73:192-204. doi: 10.1016/j.bbi.2018.04.017. Epub 2018 May 1.
- Background: PubMed 25539506Barbosa IG, Rocha NP, Assis F, Vieira EL, Soares JC, Bauer ME, Teixeira AL. Monocyte and lymphocyte activation in bipolar disorder: a new piece in the puzzle of immune dysfunction in mood disorders. Int J Neuropsychopharmacol. 2014 Oct 31;18(1):pyu021. doi: 10.1093/ijnp/pyu021.
- Background: PubMed 29169634Harrison PJ, Geddes JR, Tunbridge EM. The Emerging Neurobiology of Bipolar Disorder. Trends Neurosci. 2018 Jan;41(1):18-30. doi: 10.1016/j.tins.2017.10.006. Epub 2017 Nov 20.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
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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.
Professor Carmen Concerto, PhD, MD contact
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 Bipolar Affective Disorders, run by University of Catania at 1 site in Italy.
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 15 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Maria Salvina Signorelli, PhD, MD (+39 095 3782791, maria.signorelli@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative mRNA Expression of CCR5 in CD8+ T Lymphocytes (time frame: At baseline (single study visit)). 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?
On the ClinicalTrials.gov record for NCT07785167, which also lists 4 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 25 Aug 2026.