An observational study in Bipolar Disorder (BD), sponsored by University Hospital, Angers. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University Hospital, Angers · Observational
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.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's planned enrollment of 60 is below the median of 158 across 339 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria specific Group 1 (Bipolar At-Risk, without prior manic/hypomanic episode) - defined by one of the following:
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
Exclusion Criteria:
Diagnostic Test: Structured clinical follow-up and psychometric assessment
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).
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).
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.
Time frame: Month 36
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 36
Psychiatric hospitalizations
Systematic collection of psychiatric hospitalizations
Time frame: Month 36
Psychotropic treatment changes
Systematic collection of major psychotropic treatment changes
Time frame: Month 36
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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