Bipolar Disorder
Conditions
Keywords
Bipolar disorders, Genetic, Biomarkers, Circadian rhythm
Brief summary
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.
Interventions
OTHERBlood sample
A blood sample is taken at inclusion of patients in the study to perform DNA analysis
DEVICEactometer
To evaluate the quality of sleep, questionnaires are completed and patients wear an actometer for 21 days. They will also complete a sleep diary
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with Bipolar I, II or Not Otherwise Specified (NOS) disorders * Euthymic * Age \> 18 * Affiliated to the French social health care system * Somatic state compatible with a blood test * Informed consent signed for the study * European
Exclusion criteria
* Patients major protected * Patients adopted * Geographical origin of grandparents unknown
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Allele frequencies | All genotyping will be performed after 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time sleeping (%) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Mean Activity (movement per minute) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Total time in bed (minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Total time in bed with and without sleep (minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Day to day Stability in Time to bed (ratio of minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Day to day Stability in activity (ratio of minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Sleep latency (minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Total time awaken during the night (minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Time awaken during the night (minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Total sleep time (minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Activity during sleep (movement per minute) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Total activity amplitude (movement per minute) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Start L5: start of the 5 hours with the lowest activity period (hours:minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| Start M10: start of the 10 hours with the highest activity period (hours:minutes) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
| 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 | — |
| Fragmentation index (ratio) | End of participation of the activity tracking module : Day 21 | Variable recorded in the activity tracking module |
Countries
France
Contacts
Primary ContactFrank Bellivier, MD, PhD
Backup ContactBruno Etain, MD
Outcome results
None listed