Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders

Not Applicable

• Conditions: Bipolar Disorder
• Interventions: Other: Blood sample; Device: actometer

• Registration Number: NCT02627404
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2015-11
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Study First Posted: 2015-12-10
• Last Update Posted: 2015-12-10
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main module	Blood sample	Blood sample
Main module	actometer	Blood sample

Primary Outcome Measures

Name	Time	Method
Allele frequencies	All genotyping will be performed after 6 years

Secondary Outcome Measures

Name	Time	Method
Total time in bed (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
Percentage of time sleeping (%)	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
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
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
Total activity amplitude (movement per minute)	End of participation of the activity tracking module : Day 21	Variable recorded in the activity tracking module
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
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
Mean Activity (movement per minute)	End of participation of the activity tracking module : Day 21	Variable recorded in the activity tracking module