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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A01465-50 | Other Identifier | IDRCB |
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Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic vulnerability factors. To help the identification of these genetic factors and to improve genotype-phenotype correlation, the identification of endophenotype through the exploration of vulnerability characteristics in unaffected first degree relatives have been recommended. For this purpose, the investigator include bipolar patients, unaffected first degree relatives and control subjects to perform genetic association studies and subphenotype analyses. In this study the investigator will focus on subgroups defined according to the existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).
Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is highly variable and difficult to predict due to lack of biomarkers of response. To explore lithium response variability and to identify biomarkers of response, the investigator characterise lithium response using "ALDA" scale to conduct pharmacogenetic studies and pharmacokinetic studies of lithium extended release, in the subpopulation of patients treated with lithium. As lithium is a circadian agent, the investigator will also explore the links between lithium response and circadian phenotypes. Finally, using Li7 magnetic spectroscopy, the investigator will compare lithium brain distribution in a small sample of good and partial responders to lithium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main module | Other | Blood sample |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | A blood sample is taken at inclusion of patients in the study to perform DNA analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allele frequencies | All genotyping will be performed after 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Activity (movement per minute) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Total time in bed (minutes) | Variable recorded in the activity tracking module |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Bellivier, MD, PhD | Contact | (0)1 40 05 42 25 | +33 | frank.bellivier@inserm.fr |
| Bruno Etain, MD | Contact | (0)1 49 81 32 90 | +33 | bruno.etain@inserm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42371207 | Derived | Libourel C, Charron M, Martinot V, Carminati M, Etain B, Hennion V. Objective sleep parameters and cognitive performance in euthymic bipolar disorder: a cross-sectional 21-day actigraphy study. Int J Bipolar Disord. 2026 Jun 27. doi: 10.1186/s40345-026-00431-z. Online ahead of print. | |
| 38159652 | Derived | Hennion V, Scott J, Martinot V, Benizri C, Marie-Claire C, Bellivier F, Etain B. Associations between actigraphy estimates of sleep and circadian rhythmicity and psychotropic medications in bipolar disorders: An exploratory study. J Affect Disord. 2024 Mar 1;348:224-228. doi: 10.1016/j.jad.2023.12.075. Epub 2023 Dec 29. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| actometer | Device | To evaluate the quality of sleep, questionnaires are completed and patients wear an actometer for 21 days. They will also complete a sleep diary |
|
| End of participation of the activity tracking module : Day 21 |
| Total time in bed with and without sleep (minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Day to day Stability in Time to bed (ratio of minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Day to day Stability in activity (ratio of minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Sleep latency (minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Total time awaken during the night (minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Time awaken during the night (minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Percentage of time sleeping (%) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Fragmentation index (ratio) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Total sleep time (minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Activity during sleep (movement per minute) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Total activity amplitude (movement per minute) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Start L5: start of the 5 hours with the lowest activity period (hours:minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Start M10: start of the 10 hours with the highest activity period (hours:minutes) | Variable recorded in the activity tracking module | End of participation of the activity tracking module : Day 21 |
| Plasma and erythrocyte lithium concentration (Meq/L) at different times after inclusion | At inclusion : time 0, 1 hour, 4 hours and 8 hours - At Day 30 : Time 0 and 1 hour |
| Lithium brain distribution using Li7 magnetic spectroscopy | Day 1 |
| 32217226 | Derived | Loftus J, Scott J, Vorspan F, Icick R, Henry C, Gard S, Kahn JP, Leboyer M, Bellivier F, Etain B. Psychiatric comorbidities in bipolar disorders: An examination of the prevalence and chronology of onset according to sex and bipolar subtype. J Affect Disord. 2020 Apr 15;267:258-263. doi: 10.1016/j.jad.2020.02.035. Epub 2020 Feb 19. |
| 30359809 | Derived | Geoffroy PA, Micoulaud Franchi JA, Maruani J, Philip P, Boudebesse C, Benizri C, Yeim S, Benard V, Brochard H, Leboyer M, Bellivier F, Etain B. Clinical characteristics of obstructive sleep apnea in bipolar disorders. J Affect Disord. 2019 Feb 15;245:1-7. doi: 10.1016/j.jad.2018.10.096. Epub 2018 Oct 9. |
| 30336349 | Derived | Richard-Lepouriel H, Kung AL, Hasler R, Bellivier F, Prada P, Gard S, Ardu S, Kahn JP, Dayer A, Henry C, Aubry JM, Leboyer M, Perroud N, Etain B. Impulsivity and its association with childhood trauma experiences across bipolar disorder, attention deficit hyperactivity disorder and borderline personality disorder. J Affect Disord. 2019 Feb 1;244:33-41. doi: 10.1016/j.jad.2018.07.060. Epub 2018 Aug 6. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |