Bipolar Disorder (BD)BAROMETRENCT07872878
BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder
An observational study of Bipolar Disorder (BD), run by University Hospital, Angers at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder (BD)
- What is being tested?
- Structured clinical follow-up and psychometric assessment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2026to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in general psychiatry wards at the CHU d'Angers and partner participating centers, presenting either with Bipolar At-Risk criteria or a diagnosed bipolar disorder, identified through routine clinical care.
Who may be able to join
- 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
- Inclusion Criteria specific Group 1 (Bipolar At-Risk, without prior manic/hypomanic episode) - defined by one of the following:
Show all 10Show fewer
- 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
- Inclusion Criteria specific Group 2 (Diagnosed Bipolar Disorder): bipolar disorder type 1 or 2 diagnosed according to DSM-5, with a history of at least one manic and/or hypomanic episode
Who cannot join
- 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)
- Person receiving involuntary psychiatric care
- Under guardianship or curatorship
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision0
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
University Hospital of Angers
Angers
Julie GARRIVET, Doctor of Medecine, + 33 (0)2 41 35 32 44, julie.garrivet@chu-angers.fr
Hospital of Laval
Laval
François KAZOUR, Professor of Medecine, +33(0)243664646, François.Kazour@chu-angers.fr
Centre de Santé Mentale Angevin
Sainte-Gemmes-sur-Loire
Efflam BREGEON, Doctor of Medecine, +33 (0)241807908, bregeon.e@gmail.com
About this study
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.
- Conditions
- Bipolar Disorder (BD)
- Being tested
- Structured clinical follow-up and psychometric assessment
- Keywords
- Bipolar At-Risk State (Prodromal)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured clinical follow-up and psychometric assessmentDiagnostic test
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 assessmentDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Bipolar At-Risk (BAR) | Not described Receives: Diagnostic Test: Structured clinical follow-up and psychometric assessment | |
| Diagnosed Bipolar Disorder (BD) | Not described Receives: Diagnostic Test: Structured clinical follow-up and psychometric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of conversion to a characterized bipolar disorder (primary outcome)
Proportion of BAR-group participants presenting a first manic or hypomanic episode meeting DSM-5 criteria, identified during a structured psychiatric interview. Non-converted status at M36 is considered as no conversion.
Measured: Month 36
Secondary outcomes (11)
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment
Manic symptoms (Young Mania Rating Scale, YMRS) compared between the BAR and diagnosed bipolar disorder groups.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Measured: Month 36
Change in depressive symptom trajectories in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score from Baseline to Final Assessment
Depressive symptoms (Montgomery-Åsberg Depression Rating Scale, MADRS, 0-60) compared between the BAR and diagnosed bipolar disorder groups.
The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60.
Measured: Month 36
Change in depressive symptom trajectories in the occurrence of mood episodes
Occurrence of mood episodes, on DSM-V as determined by the investigator, compared between the BAR and diagnosed bipolar disorder groups.
Measured: Month 36
Change in global functioning with the Clinical Global Impressions scale from Baseline to Final Assessment
Global functioning assessed with Clinical Global Impression (CGI) compared between the BAR and diagnosed bipolar disorder groups.
The CGI scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill).
Measured: Month 36
Change in quality of life
Quality of life assessed with WHOQOL-BREF (4 domains), compared between the BAR and diagnosed bipolar disorder groups.
Domain Score on World Health Organization Quality of Life - Brief (WHOQOL-BREF) survey. The survey consists of 26 questions and evaluates four domains of quality of life including physical health (domain 1), psychological (domain 2), social relationships (domain 3), and environment (domain 4). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range between 4-20, comparable with the WHOQOL-100.
Measured: Month 36
Change in suicidal risk severity
Suicidal ideation and behavior assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS), compared between the BAR group and the diagnosed bipolar disorder group.
Columbia Suicide Severity Rating Scale (C-SSRS) is a tool for evaluating the risk of individual suicide. It includes a series of questions to evaluate the frequency, intensity, persistence and concreteness of individual suicide behavior in the past period of time. The purpose of C-SSRS scale is to distinguish between suicidal ideation and suicidal attempt and higher scores mean a worse outcome. Developed by researchers from Columbia University, the scale is widely used in clinical and research fields to help identify and manage suicide risks.
Measured: Month 36
Change in sleep quality
Sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI, 0-21), compared between the BAR and diagnosed bipolar disorder groups, and explored by conversion status within the BAR group.
The total items of Pittsburgh Sleep Quality Index inventory are 7. The score of each item is from 0-3. The score>5 points means the sleep quality is good. Meanwhile the score ≦5 points is poor sleep quality.
Measured: Month 36
Trauma exposure
Traumatic exposure assessed with the Traumatic Experiences Checklist (TEC), compared between groups and explored in relation to diagnostic conversion within the BAR group. The TEC is a self-report measure addressing 29 types of potentially traumatic events. It is a 29-item retrospective self-report scale. It is a reliable and valid self-report instrument that can be used in clinical practice and research. Different scores can be calculated, including a cumulative score, and scores for emotional neglect, emotional abuse, physical abuse, sexual harassment, sexual abuse, and bodily threat from a person.
Measured: Month 36
PTSD symptoms exposure
Post-traumatic stress symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5, 0-80), compared between groups and explored in relation to diagnostic conversion within the BAR group.
The post traumatic stress disorder checklist scale (PLC-5) is 20-item scale to assess post-traumatic stress symptoms. Participants respond to each item using a 5-point Likert scale. The score ranges between 0 and 80, with 0 reflecting no post traumatic stress disorder.
Measured: Month 36
Psychiatric hospitalizations
Systematic collection of psychiatric hospitalizations
Measured: Month 36
Psychotropic treatment changes
Systematic collection of major psychotropic treatment changes
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Julie GARRIVET, Doctor of Medecine, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872878
- Sponsor's protocol ID
- 49RC26_0032
- Other IDs
- 2026-A01551-50
- Acronym
- BAROMETRE
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided