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NOT YET RECRUITING
NCT07872878

BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder

Sponsor: University Hospital, Angers

View on ClinicalTrials.gov

Summary

Bipolar disorder (BD) is often diagnosed 5 to 10 years after first symptoms, worsening prognosis. "Bipolar At-Risk" (BAR) criteria have been developed to identify people who may be in an early, prodromal stage of BD, but their long-term clinical course is not well characterized. BAROMETRE is a prospective, multicenter, naturalistic study following two groups of hospitalized psychiatric patients aged 18-65 for 36 months: patients meeting BAR criteria (without prior manic/hypomanic episode) and patients with an already diagnosed bipolar disorder (type 1 or 2), used as a clinical reference group. No experimental treatment is imposed; patients receive usual care. At inclusion, 1, 12, 24 and 36 months, participants undergo structured psychiatric interviews and clinician-rated scales (YMRS, MADRS, CGI, C-SSRS, Sachs Bipolarity Index); at 6, 18 and 30 months they complete self-report questionnaires by phone or online (BDI, HCL-32, PSQI, WHOQOL). The main hypothesis is that a clinically significant proportion (around 20%) of BAR patients will convert to a full bipolar disorder (first DSM-5 manic/hypomanic episode) within 36 months. Secondary aims are to describe and compare mood, functioning, quality of life, suicidality, sleep, substance use, trauma/PTSD symptoms, and care pathways (hospitalizations, treatment changes) between the two groups, and, exploratorily, between BAR patients who convert and those who do not. This pilot study aims to better characterize the evolution of at-risk states and generate hypotheses for larger confirmatory studies.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-11

Completion Date

2030-12

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Structured clinical follow-up and psychometric assessment

Structured psychiatric interviews (DSM-5 criteria) and clinician-rated/self-report scales (YMRS, MADRS, CGI, C-SSRS, Sachs Bipolarity Index, BDI, HCL-32, WHOQOL, PSQI, TEC, PCL-5) administered at T0, M1, M6, M12, M18, M24, M30, M36, in-person or by phone, as part of routine naturalistic follow-up (no experimental treatment).

DIAGNOSTIC_TEST

Structured clinical follow-up and psychometric assessment

Structured psychiatric interviews (DSM-5 criteria) and clinician-rated/self-report scales (YMRS, MADRS, CGI, C-SSRS, Sachs Bipolarity Index, BDI, HCL-32, WHOQOL, PSQI, TEC, PCL-5) administered at T0, M1, M6, M12, M18, M24, M30, M36, in-person or by phone, as part of routine naturalistic follow-up (no experimental treatment).

Locations (3)

University Hospital of Angers

Angers, France

Hospital of Laval

Laval, France

Centre de Santé Mentale Angevin

Sainte-Gemmes-sur-Loire, France