BAROMETRENCT07872878

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

StatusNot Yet Recruiting

PhaseNot specified

SponsorUniversity Hospital, Angers

Primary completionDec 2030 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 7, 2026 Study First Submitted

Endpoints

Primary

Cumulative incidence of conversion to a characterized bipolar disorder (primary outcome)

Timeframe: Month 36

Secondary (11)

Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment

Change in depressive symptom trajectories in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score from Baseline to Final Assessment

Change in depressive symptom trajectories in the occurrence of mood episodes

Change in global functioning with the Clinical Global Impressions scale from Baseline to Final Assessment

Change in quality of life

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Change in suicidal risk severity

Change in sleep quality

Trauma exposure

PTSD symptoms exposure

Psychiatric hospitalizations

Psychotropic treatment changes

Arms and interventions

Bipolar At-Risk (BAR)

Diagnosed Bipolar Disorder (BD)

Diagnostic tests: Structured clinical follow-up and psychometric assessment

Sites

3 sites in 1 country

About this trial

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.

Trial details

Enrollment: 60 participants (estimated)
Started: Nov 2026
Study completion: Dec 2030 (estimated)
Eligibility: 18 to 65, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Bipolar Disorder, Bipolar Disorder (BD)
First posted: Oct 14, 2026
Registry updated: Oct 14, 2026
Last verified: Oct 2026

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