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

• Structured clinical follow-up and psychometric assessment (Diagnostic 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 assessment (Diagnostic 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).

Primary outcomes

• Cumulative incidence of conversion to a characterized bipolar disorder (primary outcome) [Month 36]: 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.

Secondary outcomes

• Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment [Month 36]: 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).
• Change in depressive symptom trajectories in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score from Baseline to Final Assessment [Month 36]: 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.
• Change in depressive symptom trajectories in the occurrence of mood episodes [Month 36]: Occurrence of mood episodes, on DSM-V as determined by the investigator, compared between the BAR and diagnosed bipolar disorder groups.
• Change in global functioning with the Clinical Global Impressions scale from Baseline to Final Assessment [Month 36]: 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).
• Change in quality of life [Month 36]: 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.
• Change in suicidal risk severity [Month 36]: 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.
• Change in sleep quality [Month 36]: 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.
• Trauma exposure [Month 36]: 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.
• PTSD symptoms exposure [Month 36]: 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.
• Psychiatric hospitalizations [Month 36]: Systematic collection of psychiatric hospitalizations
• Psychotropic treatment changes [Month 36]: Systematic collection of major psychotropic treatment changes

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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:

1. 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
2. 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
3. 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

Exclusion Criteria:

* 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

• Julie GARRIVET, Doctor of Medecine, Principal investigator, University Hospital, Angers