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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
This is not medical advice. Consult your specialist.
View the official record on ClinicalTrials.gov →