NCT02627404

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 10, 2015

Status Verified

November 1, 2015

Enrollment Period

5 years

First QC Date

November 13, 2015

Last Update Submit

December 8, 2015

Conditions

Bipolar Disorder

Keywords

Bipolar disordersGeneticBiomarkersCircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • Allele frequencies

    All genotyping will be performed after 6 years

Secondary Outcomes (17)

  • Mean Activity (movement per minute)

    End of participation of the activity tracking module : Day 21

  • Total time in bed (minutes)

    End of participation of the activity tracking module : Day 21

  • Total time in bed with and without sleep (minutes)

    End of participation of the activity tracking module : Day 21

  • Day to day Stability in Time to bed (ratio of minutes)

    End of participation of the activity tracking module : Day 21

  • Day to day Stability in activity (ratio of minutes)

    End of participation of the activity tracking module : Day 21

  • +12 more secondary outcomes

Study Arms (1)

Main module

OTHER

Blood sample

Other: Blood sampleDevice: actometer

Interventions

Blood sampleOTHER

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

Main module
actometerDEVICE

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

Main module

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients major protected
  • Patients adopted
  • Geographical origin of grandparents unknown

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, 75010, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 38159652DERIVED

  • 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.

    PMID: 32217226DERIVED

  • 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.

    PMID: 30359809DERIVED

  • 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.

    PMID: 30336349DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Frank Bellivier, MD, PhD

CONTACT

(0)1 40 05 42 25frank.bellivier@inserm.fr

Bruno Etain, MD

CONTACT

(0)1 49 81 32 90bruno.etain@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

December 10, 2015

Study Start

September 1, 2013

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

December 10, 2015

Record last verified: 2015-11

Locations

FR(1)