An observational study in Bipolar Affective Disorders, sponsored by University of Catania. Not yet recruiting at 1 site in Italy. Open to participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University of Catania · Observational
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.
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.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 172 is below the median of 200 across 135 observational studies indexed under Mood Disorders.
Browse Mood Disorders studies →University of Catania is the lead sponsor of 71 studies on the registry; 15 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with Bipolar Disorder:
Healthy Controls Group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: CD8+ T-Cell Gene Expression Analysis
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.
Other: CD8+ T-Cell Gene Expression Analysis
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.
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.
Time frame: 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.
Time frame: At baseline (single study visit)
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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline (single study visit)
CCR5 mRNA Expression According to Current Mood Phase
Relative CCR5 mRNA expression in purified CD8+ T lymphocytes will be compared between participants with Bipolar Disorder experiencing a depressive episode and those experiencing a manic or hypomanic episode.
Time frame: At baseline (single study visit)
CXCR3 mRNA Expression According to Current Mood Phase
Relative CXCR3 mRNA expression in purified CD8+ T lymphocytes will be compared between participants with Bipolar Disorder experiencing a depressive episode and those experiencing a manic or hypomanic episode.
Time frame: At baseline (single study visit)
PSGL-1 mRNA Expression According to Current Mood Phase
Relative PSGL-1 mRNA expression in purified CD8+ T lymphocytes will be compared between participants with Bipolar Disorder experiencing a depressive episode and those experiencing a manic or hypomanic episode.
Time frame: At baseline (single study visit)
VLA-4 mRNA Expression According to Current Mood Phase
Relative VLA-4 mRNA expression in purified CD8+ T lymphocytes will be compared between participants with Bipolar Disorder experiencing a depressive episode and those experiencing a manic or hypomanic episode.
Time frame: At baseline (single study visit)
LFA-1 mRNA Expression According to Current Mood Phase
Relative LFA-1 mRNA expression in purified CD8+ T lymphocytes will be compared between participants with Bipolar Disorder experiencing a depressive episode and those experiencing a manic or hypomanic episode.
Time frame: At baseline (single study visit)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data are not planned to be shared.
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University of Catania