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New study aims to map bipolar Disorder's path using blood and brain scans

NCT ID NCT07343739

Knowledge-focused Sponsor: ASST Fatebenefratelli Sacco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This observational study is tracking 126 people with bipolar disorder over 18 months to better understand how the condition progresses. Researchers will collect clinical data, blood and saliva samples, and brain scans at several time points. The goal is to combine all this information to create a more accurate staging model for bipolar disorder, which could eventually help tailor treatments to each person's stage of illness.

What this could mean

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

What this could lead to
If successful, this study could lead to a more precise way to track bipolar disorder progression and guide personalized treatments.
What could go wrong
This is an observational study, not a treatment trial. It may not directly lead to new therapies, and the findings may not apply to all patients.

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

126 people

The number who actually took part.

Started

Nov 2023

Expected to finish

May 2026

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

Subjects affected and unaffected by BD whose clinical stage falls within those defined by the Kupka and Hillegers model, namely: stage 0 (increased risk: having a first-degree relative with BD, in the absence of psychiatric symptoms); stage 1 (having a first-degree relative with BD, in the presence of non-specific psychiatric symptoms or depressive episode(s)); stage 2 (first hypo/manic episode allowing a diagnosis of BD type I or II according to DSM-5; APA, 2013); stage 3 (recurrent episode(s): depressive, hypo/manic, or mixed); stage 4 (persistent non-remitting disorder: chronic depressive, manic, or mixed episodes, including rapid cycling);

Ages

18 to 70 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. A range of bipolar spectrum manifestations meeting the criteria of the Kupka \& Hillegers' staging model 2. Both genders 3. Age ≥18 and ≤70 years 4. Written informed consent obtained Exclusion Criteria: 1. Inability to provide informed consent 2. Diagnosis of intellectual disability 3. Presence of a severe medical condition (e.g., previously diagnosed neurological disorders, including chronic migraine, hematological diseases, renal disorders, history of stroke, or diabetes mellitus, even if compensated; controlled hypertension allowed) 4. Current substance use disorder or within six months prior to screening

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

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

Bipolar disorder

Contacts and locations

Locations

  • ASST Fatebenefratelli Sacco

    Milan, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.