Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders
NCT ID: NCT02627404
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2013-09-30
2018-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Main module
Blood sample
Blood sample
A blood sample is taken at inclusion of patients in the study to perform DNA analysis
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
Interventions
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Blood sample
A blood sample is taken at inclusion of patients in the study to perform DNA analysis
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
Eligibility Criteria
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Inclusion Criteria
* 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 adopted
* Geographical origin of grandparents unknown
18 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Frank BELLIVIER, MD, PHD
Role: primary
Florence Couppey, CRA
Role: backup
References
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Hennion V, Scott J, Martinot V, Benizri C, Marie-Claire C, Bellivier F, Etain B. Associations between actigraphy estimates of sleep and circadian rhythmicity and psychotropic medications in bipolar disorders: An exploratory study. J Affect Disord. 2024 Mar 1;348:224-228. doi: 10.1016/j.jad.2023.12.075. Epub 2023 Dec 29.
Loftus J, Scott J, Vorspan F, Icick R, Henry C, Gard S, Kahn JP, Leboyer M, Bellivier F, Etain B. Psychiatric comorbidities in bipolar disorders: An examination of the prevalence and chronology of onset according to sex and bipolar subtype. J Affect Disord. 2020 Apr 15;267:258-263. doi: 10.1016/j.jad.2020.02.035. Epub 2020 Feb 19.
Geoffroy PA, Micoulaud Franchi JA, Maruani J, Philip P, Boudebesse C, Benizri C, Yeim S, Benard V, Brochard H, Leboyer M, Bellivier F, Etain B. Clinical characteristics of obstructive sleep apnea in bipolar disorders. J Affect Disord. 2019 Feb 15;245:1-7. doi: 10.1016/j.jad.2018.10.096. Epub 2018 Oct 9.
Richard-Lepouriel H, Kung AL, Hasler R, Bellivier F, Prada P, Gard S, Ardu S, Kahn JP, Dayer A, Henry C, Aubry JM, Leboyer M, Perroud N, Etain B. Impulsivity and its association with childhood trauma experiences across bipolar disorder, attention deficit hyperactivity disorder and borderline personality disorder. J Affect Disord. 2019 Feb 1;244:33-41. doi: 10.1016/j.jad.2018.07.060. Epub 2018 Aug 6.
Other Identifiers
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2008-A01465-50
Identifier Type: OTHER
Identifier Source: secondary_id
P111002
Identifier Type: -
Identifier Source: org_study_id