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Could immune cells hold clues to bipolar disorder?

NCT ID NCT07785167

Knowledge-focused Sponsor: University of Catania Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study looks at whether certain immune cells (CD8+ T lymphocytes) show different patterns of gene activity in people with bipolar disorder compared to healthy individuals. Researchers will measure markers that help these cells travel to the brain, and they will also check if these markers change during depressive or manic episodes. The goal is to better understand the role of the immune system in bipolar disorder.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CD8+ T-cell gene expression analysis (blood test measuring immune markers)
What this could lead to
If differences are found, this could point toward immune-related biomarkers for bipolar disorder and possibly new treatment targets.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may not apply to all people with bipolar disorder, and the sample is limited to a specific age range.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

25 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder bipolar II disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar affective disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Psychiatry Unit, Policlinico "G.Rodolico" Hospital, Via Santa Sofia 78

    Catania, Sicily, 95123, Italy

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