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

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
actometer
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Disorder focused on measuring Bipolar disorders, Genetic, Biomarkers, Circadian rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Main module

Arm Description

Blood sample

Outcomes

Primary Outcome Measures

Allele frequencies

Secondary Outcome Measures

Mean Activity (movement per minute)
Variable recorded in the activity tracking module
Total time in bed (minutes)
Variable recorded in the activity tracking module
Total time in bed with and without sleep (minutes)
Variable recorded in the activity tracking module
Day to day Stability in Time to bed (ratio of minutes)
Variable recorded in the activity tracking module
Day to day Stability in activity (ratio of minutes)
Variable recorded in the activity tracking module
Sleep latency (minutes)
Variable recorded in the activity tracking module
Total time awaken during the night (minutes)
Variable recorded in the activity tracking module
Time awaken during the night (minutes)
Variable recorded in the activity tracking module
Percentage of time sleeping (%)
Variable recorded in the activity tracking module
Fragmentation index (ratio)
Variable recorded in the activity tracking module
Total sleep time (minutes)
Variable recorded in the activity tracking module
Activity during sleep (movement per minute)
Variable recorded in the activity tracking module
Total activity amplitude (movement per minute)
Variable recorded in the activity tracking module
Start L5: start of the 5 hours with the lowest activity period (hours:minutes)
Variable recorded in the activity tracking module
Start M10: start of the 10 hours with the highest activity period (hours:minutes)
Variable recorded in the activity tracking module
Plasma and erythrocyte lithium concentration (Meq/L) at different times after inclusion
Lithium brain distribution using Li7 magnetic spectroscopy

Full Information

First Posted
November 13, 2015
Last Updated
December 8, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02627404
Brief Title
Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders
Acronym
GAN
Official Title
Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar disorders, Genetic, Biomarkers, Circadian rhythm

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main module
Arm Type
Other
Arm Description
Blood sample
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
A blood sample is taken at inclusion of patients in the study to perform DNA analysis
Intervention Type
Device
Intervention Name(s)
actometer
Intervention Description
To evaluate the quality of sleep, questionnaires are completed and patients wear an actometer for 21 days. They will also complete a sleep diary
Primary Outcome Measure Information:
Title
Allele frequencies
Time Frame
All genotyping will be performed after 6 years
Secondary Outcome Measure Information:
Title
Mean Activity (movement per minute)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Total time in bed (minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Total time in bed with and without sleep (minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Day to day Stability in Time to bed (ratio of minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Day to day Stability in activity (ratio of minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Sleep latency (minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Total time awaken during the night (minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Time awaken during the night (minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Percentage of time sleeping (%)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Fragmentation index (ratio)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Total sleep time (minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Activity during sleep (movement per minute)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Total activity amplitude (movement per minute)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Start L5: start of the 5 hours with the lowest activity period (hours:minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Start M10: start of the 10 hours with the highest activity period (hours:minutes)
Description
Variable recorded in the activity tracking module
Time Frame
End of participation of the activity tracking module : Day 21
Title
Plasma and erythrocyte lithium concentration (Meq/L) at different times after inclusion
Time Frame
At inclusion : time 0, 1 hour, 4 hours and 8 hours - At Day 30 : Time 0 and 1 hour
Title
Lithium brain distribution using Li7 magnetic spectroscopy
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Bellivier, MD, PhD
Phone
(0)1 40 05 42 25
Ext
+33
Email
frank.bellivier@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Etain, MD
Phone
(0)1 49 81 32 90
Ext
+33
Email
bruno.etain@inserm.fr
Facility Information:
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank BELLIVIER, MD, PHD
Phone
(0)1 40 05 42 25
Ext
+33
Email
frank.bellivier@inserm.fr
First Name & Middle Initial & Last Name & Degree
Florence Couppey, CRA
Phone
(0)1 49 81 37 52
Ext
+33
Email
florence.couppey@aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
32217226
Citation
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.
Results Reference
derived
PubMed Identifier
30359809
Citation
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.
Results Reference
derived
PubMed Identifier
30336349
Citation
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.
Results Reference
derived

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

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