Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder

ConditionBipolar Affective Disorders

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age25-35

SponsorUniversity of Catania

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

CD8+ T-Cell Gene Expression Analysis
Other intervention
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.

Treatment groups

172 Participants

are divided into 2 treatment groups

Group A: Bipolar Disorder Group1 intervention

Group B: Healthy Control Group1 intervention

Trial outcomes

Primary outcomes

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