Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Allele frequencies
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Bipolar I, II or Not Otherwise Specified (NOS) disorders
- •Age > 18
- •Affiliated to the French social health care system
- •Somatic state compatible with a blood test
- •Informed consent signed for the study
排除标准
- •Patients major protected
- •Patients adopted
- •Geographical origin of grandparents unknown
结局指标
主要结局
Allele frequencies
时间窗: All genotyping will be performed after 6 years
次要结局
- Total time in bed (minutes)(End of participation of the activity tracking module : Day 21)
- Sleep latency (minutes)(End of participation of the activity tracking module : Day 21)
- Total time awaken during the night (minutes)(End of participation of the activity tracking module : Day 21)
- Time awaken during the night (minutes)(End of participation of the activity tracking module : Day 21)
- Percentage of time sleeping (%)(End of participation of the activity tracking module : Day 21)
- Total sleep time (minutes)(End of participation of the activity tracking module : Day 21)
- Activity during sleep (movement per minute)(End of participation of the activity tracking module : Day 21)
- Start L5: start of the 5 hours with the lowest activity period (hours:minutes)(End of participation of the activity tracking module : Day 21)
- Start M10: start of the 10 hours with the highest activity period (hours:minutes)(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)
- Day to day Stability in activity (ratio of minutes)(End of participation of the activity tracking module : Day 21)
- Total activity amplitude (movement per minute)(End of participation of the activity tracking module : Day 21)
- Lithium brain distribution using Li7 magnetic spectroscopy(Day 1)
- Fragmentation index (ratio)(End of participation of the activity tracking module : Day 21)
- Total time in bed with and without sleep (minutes)(End of participation of the activity tracking module : Day 21)
- Day to day Stability in Time to bed (ratio of minutes)(End of participation of the activity tracking module : Day 21)
- Mean Activity (movement per minute)(End of participation of the activity tracking module : Day 21)