Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders (GAN)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Bipolar Disorder

Treatments: Device: actometer; Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02627404

P111002

2008-A01465-50 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Main module

Other group

Description:

Blood sample

Treatment:

Device: actometer

Other: Blood sample