NCT07872878Not yet recruiting
BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- University Hospital, Angers
- Diseases
- Bipolar disorder
- NCT number
- NCT07872878
What you commit to
- Study type: Observational
- Planned participants: 60
- From Nov 2026 to the primary completion date, Dec 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Person receiving involuntary psychiatric care
Other illness
- Diagnosis of psychotic disorder (schizophrenia, delusional disorder)
- Known intellectual disability or severe autism spectrum disorder (except ADHD)
- Confirmed neurodegenerative disorder
- Psychiatric syndrome of other organic origin (e.g., head trauma, neurological or endocrine disorder)
Other
- Under guardianship or curatorship
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision0
Who the study is looking for
- Aged 18 to 65 years
- Hospitalized in a psychiatric ward in one of the participating centers
- French-speaking
- Able to understand the study objectives and to give free, informed, signed consent
- Affiliated to a social security scheme
- Subsyndromal hypomania: abnormally and persistently elevated, expansive or irritable mood for at least 2 but fewer than 4 consecutive days, plus at least 2 of: increased self-esteem/grandiosity, decreased need for sleep, increased talkativeness, flight of ideas, distractibility, increased goal-directed activity or psychomotor agitation
- Depression with cyclothymic features: major depressive episode (DSM-5) plus a history of numerous subsyndromal hypomanic episodes (not meeting criteria of group a) and numerous depressive episodes
- Depression with genetic risk: major depressive episode (DSM-5) plus a first-degree relative with bipolar disorder
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital of Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Hospital of Laval Coordinator of this site? Confirm its status | Laval | France | Unknown status |
| Centre de Santé Mentale Angevin Coordinator of this site? Confirm its status | Sainte-Gemmes-sur-Loire | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.