[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653285":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":58,"overallOfficials":43,"centralContacts":63,"locations":72,"responsibleParty":110,"collaborators":43,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":43,"studyType":128,"phases":43,"briefSummary":129,"conditions":130,"keywords":43,"overallStatus":132,"whyStopped":43,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of Catania","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","At baseline (single study visit)",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",[27,30,33,36,39],{"measure":28,"description":29,"timeFrame":12},"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.",{"measure":31,"description":32,"timeFrame":12},"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.",{"measure":34,"description":35,"timeFrame":12},"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.",{"measure":37,"description":38,"timeFrame":12},"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.",{"measure":40,"description":41,"timeFrame":12},"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.",{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":44,"timePerspective":45,"maskingInfo":43},null,"CASE_CONTROL","CROSS_SECTIONAL","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.\n\nThe 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.\n\nThe 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.\n\nPeripheral 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.\n\nThe 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.","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\u002Fhospital 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.",[49,54],{"label":50,"type":43,"description":51,"interventionNames":52},"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\u002Fhypomanic episodes.",[53],"Other: CD8+ T-Cell Gene Expression Analysis",{"label":55,"type":43,"description":56,"interventionNames":57},"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 \\\u003C8 and a Mania Rating Scale score \\\u003C11.",[53],[59],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":43},"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.",[50,55],[64,69],{"name":65,"role":66,"phone":67,"phoneExt":43,"email":68},"Professor Maria Salvina Signorelli, PhD, MD","CONTACT","+39 095 3782791","maria.signorelli@unict.it",{"name":70,"role":66,"phone":43,"phoneExt":43,"email":71},"Professor Carmen Concerto, PhD, MD","carmen.concerto@unict.it",[73],{"facility":74,"status":43,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Psychiatry Unit, Policlinico \"G.Rodolico\" Hospital, Via Santa Sofia 78","Catania","Sicily","95123","Italy","IT",{"type":81,"coordinates":82},"Point",[83,84],15.07041,37.49223,{"lat":84,"lon":83},[87,89,92,94,96,98,100,102,104,106,108],{"name":88,"role":66,"phone":67,"phoneExt":43,"email":68},"Professor Maria Salvina Signorelli, MD, PhD",{"name":90,"role":91,"phone":43,"phoneExt":43,"email":43},"Professor Carmen Concerto, MD, PhD","SUB_INVESTIGATOR",{"name":93,"role":91,"phone":43,"phoneExt":43,"email":43},"Professor Antonino Petralia, MD, PhD",{"name":95,"role":91,"phone":43,"phoneExt":43,"email":43},"Professor Santa Cinzia Di Pietro, PhD",{"name":97,"role":91,"phone":43,"phoneExt":43,"email":43},"Dr Ludovico Mineo, MD, PhD",{"name":99,"role":91,"phone":43,"phoneExt":43,"email":43},"Dr Lucia Basile, MD",{"name":101,"role":91,"phone":43,"phoneExt":43,"email":43},"Dr Fabrizio Bella, MD",{"name":103,"role":91,"phone":43,"phoneExt":43,"email":43},"Dr Cecilia Chiarenza, MD",{"name":105,"role":91,"phone":43,"phoneExt":43,"email":43},"Dr Carmen Ferrara, PhD",{"name":107,"role":91,"phone":43,"phoneExt":43,"email":43},"Dr Angela Caponnetto, PhD",{"name":88,"role":109,"phone":43,"phoneExt":43,"email":43},"PRINCIPAL_INVESTIGATOR",{"type":109,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Carmen Concerto","Clinical Professor","100653285","chemokine-receptors-on-cd8-t-cells-in-patients-with-bipolar-disorder-100653285",false,"NCT07785167","Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder","Characterization of Chemokine Receptor Expression in CD8+ T Lymphocytes in Bipolar Disorder","SPERLIC","Inclusion Criteria:\n\n1. Participants with Bipolar Disorder:\n\n   * Age 25 to 35 years.\n   * Male or female; female participants must be in the mid-luteal phase of the menstrual cycle.\n   * Clinical presentation consistent with a diagnosis of Bipolar I Disorder or Bipolar II Disorder.\n   * First diagnosis of Bipolar Disorder with no previous psychopharmacological treatment (drug-naive), or absence of psychopharmacological treatment for at least 6 months (drug-free).\n   * Ability and willingness to provide written informed consent.\n2. Healthy Controls Group:\n\n   * Age 25 to 35 years.\n   * Male or female; female participants must be in the mid-luteal phase of the menstrual cycle.\n   * No current treatment with psychotropic medications.\n   * No clinical or symptomatic evidence supporting a diagnosis of Bipolar I Disorder or Bipolar II Disorder.\n   * Hamilton Depression Rating Scale (HAM-D) score \\\u003C8.\n   * Mania Rating Scale (MRS) score \\\u003C11.\n   * No major stressful life events during the previous 6 months, such as bereavement, traumatic events, or divorce.\n   * Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Current treatment with corticosteroids, immunosuppressive agents, antibiotics, or hormone replacement therapy.\n* Relevant current medical comorbidities, including autoimmune diseases or other clinically significant internal medicine conditions.\n* Relevant psychiatric comorbidities.\n* Current psychopharmacological treatment or psychopharmacological treatment discontinued less than 6 months before enrollment.",true,"ALL","25 Years","35 Years",{"count":126,"type":127},172,"ESTIMATED","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\u002Fhypomanic phases. Gene expression will be assessed by real-time PCR in purified CD8+ T lymphocytes obtained from peripheral blood samples.",[131],"Bipolar Affective Disorders","NOT_YET_RECRUITING","2026-08-20",{"date":135,"type":136},"2026-08-25","ACTUAL",{"date":138,"type":127},"2026-09-07",{"date":140,"type":127},"2028-09-07",{"name":5,"class":6},1]