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Immune cell markers in adults with bipolar disorder compared with healthy people

Compares markers on CD8+ T cells in blood of people with and without bipolar disorder.

Plain-language title generated from the registry record
Registry title: Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder

Key facts

Where
Catania, ItalySee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 25 and 35 years old?

Source: NCT07785167, who can take part

Where in Italy

  • Psychiatry Unit, Policlinico "G.Rodolico" Hospital, Via Santa Sofia 78Catania, ItalyNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Catania
Trial code
NCT07785167
Record updated
25 August 2026
Original description
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 full original descriptionShow less

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.

Inclusion: 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; 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: Current treatment with corticosteroids, immunosuppressive agents, antibiotics, or hormone replacement therapy; Current psychopharmacological treatment or psychopharmacological treatment discontinued less than 6 months before enrollment; Relevant current medical comorbidities, including autoimmune diseases or other clinically significant internal medicine conditions; Relevant psychiatric comorbidities.

ClinicalTrials.gov NCT07785167