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.
Study 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. 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.
Eligibility
Sex
ALL
Min age
25 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. 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.
2. 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Relative mRNA Expression of CCR5 in CD8+ T Lymphocytes — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Psychiatry Unit, Policlinico "G.Rodolico" Hospital, Via Santa Sofia 78
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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