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NCT07785167
Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder
Conditions: Bipolar Affective Disorders
Sex: All
Ages: 25 Years – 35 Years
Healthy volunteers: Yes
Enrollment: 172
Sponsor: University of Catania
Location: Psychiatry Unit, Policlinico "G.Rodolico" Hospital, Via Santa Sofia 78 Catania Sicily
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07785167). StuddyBuddy aggregates publicly available trial information.