NCT07785167Not yet recruiting
Chemokine Receptors on CD8+ T Cells in Patients With Bipolar Disorder
Characterization of Chemokine Receptor Expression in CD8+ T Lymphocytes in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 172 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 7 Sept 2026
- Primary completion date
- 7 Sept 2028
- Lead sponsor
- University of Catania
- Diseases
- Bipolar disorder
- NCT number
- NCT07785167
What you commit to
- Study type: Observational
- Planned participants: 172
- From 7 Sept 2026 to the primary completion date, 7 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with corticosteroids, immunosuppressive agents, antibiotics, or hormone replacement therapy.
- Current psychopharmacological treatment or psychopharmacological treatment discontinued less than 6 months before enrollment.
Other illness
- Relevant current medical comorbidities, including autoimmune diseases or other clinically significant internal medicine conditions.
- Relevant psychiatric comorbidities.
Who the study is looking for
- 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.
Age in the registry: 25 years to 35 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatry Unit, Policlinico "G.Rodolico" Hospital, Via Santa Sofia 78 Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.