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

Bipolar Disorder Clinical Trial

— GAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627404
• Other study ID #: P111002
• Secondary ID: 2008-A01465-50
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2015
• Last updated: December 8, 2015
• Start date: September 2013
• Est. completion date: September 2018

Study information

• Verified date: November 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Frank Bellivier, MD, PhD
• Phone: (0)1 40 05 42 25
• Email: frank.bellivier[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• Blood sample
A blood sample is taken at inclusion of patients in the study to perform DNA analysis

Device:
• actometer
To evaluate the quality of sleep, questionnaires are completed and patients wear an actometer for 21 days. They will also complete a sleep diary

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allele frequencies		All genotyping will be performed after 6 years	No
Secondary	Mean Activity (movement per minute)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Total time in bed (minutes)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Sleep latency (minutes)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Total time awaken during the night (minutes)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Time awaken during the night (minutes)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Percentage of time sleeping (%)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Fragmentation index (ratio)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Total sleep time (minutes)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Activity during sleep (movement per minute)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	Total activity amplitude (movement per minute)	Variable recorded in the activity tracking module	End of participation of the activity tracking module : Day 21	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Lithium brain distribution using Li7 magnetic spectroscopy		Day 1	No