Bipolar Disorder Integrative Staging: Incorporating Biomarkers Into Progression Across Stages

Plain-language summary

This study aims to incorporate biomarkers into clinical assessments to understand how bipolar disorder progresses across stages; it collects psychometric clinical assessments, biological samples, and neuroimaging data. It enrolls men and women aged 18 to 70 with bipolar-spectrum manifestations. It is a study with no assigned phase and is not currently recruiting but is still ongoing.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

ASST Fatebenefratelli Sacco

Intervention

psychometric clinical assessment, biological acquisition, neuroimaging data

Start date

11/8/2023

Estimated completion

5/20/2026

Countries

Italy

Related genes

Locations

• Milan, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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