Clinical Research Directory
Browse clinical research sites, groups, and studies.
BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder
Sponsor: University Hospital, Angers
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
Conditions
Interventions
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).
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