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AzTrials

Bipolar DisorderGANNCT02627404

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

A study testing Blood sample and actometer in people with Bipolar Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder
What is being tested?
Blood sample and actometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteFrance
Study dates
Sep 2013to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Frank Bellivier, MD, PhD contact

(0)1 40 05 42 25 ext. +33

frank.bellivier@inserm.fr

Bruno Etain, MD contact

(0)1 49 81 32 90 ext. +33

bruno.etain@inserm.fr

France1 site, 1 recruiting

  • Study site

    Paris, 75010

    Frank BELLIVIER, MD, PHD, (0)1 40 05 42 25 ext. +33, frank.bellivier@inserm.fr

    Florence Couppey, CRA, (0)1 49 81 37 52 ext. +33, florence.couppey@aphp.fr

    Recruiting

Other trials in France

About this study

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.

Being tested
Blood sample, actometer
Keywords
Bipolar disorders, Genetic, Biomarkers, Circadian rhythm
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleOther

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

  • 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

Study groups in NCT02627404
Study groupRoleWhat they receive
Main moduleOtherBlood sample
Receives: Other: Blood sample; Device: actometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Allele frequencies

    Measured: All genotyping will be performed after 6 years

Secondary outcomes (17)

  1. Mean Activity (movement per minute)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  2. Total time in bed (minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  3. Total time in bed with and without sleep (minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

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

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  5. Day to day Stability in activity (ratio of minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  6. Sleep latency (minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  7. Total time awaken during the night (minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  8. Time awaken during the night (minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  9. Percentage of time sleeping (%)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  10. Fragmentation index (ratio)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  11. Total sleep time (minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  12. Activity during sleep (movement per minute)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  13. Total activity amplitude (movement per minute)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  14. Start L5: start of the 5 hours with the lowest activity period (hours:minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  15. Start M10: start of the 10 hours with the highest activity period (hours:minutes)

    Variable recorded in the activity tracking module

    Measured: End of participation of the activity tracking module : Day 21

  16. Plasma and erythrocyte lithium concentration (Meq/L) at different times after inclusion

    Measured: At inclusion : time 0, 1 hour, 4 hours and 8 hours - At Day 30 : Time 0 and 1 hour

  17. Lithium brain distribution using Li7 magnetic spectroscopy

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02627404
Sponsor's protocol ID
P111002
Other IDs
2008-A01465-50
Acronym
GAN
Status last verified
Nov 2015
First submitted
13 Nov 2015
Last updated
10 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Libourel C, Charron M, Martinot V, Carminati M, Etain B, Hennion V. Objective sleep parameters and cognitive performance in euthymic bipolar disorder: a cross-sectional 21-day actigraphy study. Int J Bipolar Disord. 2026 Jun 27. doi: 10.1186/s40345-026-00431-z. Online ahead of print.

    PubMed 42371207

  • 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.

    PubMed 38159652

  • 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.

    PubMed 32217226

  • 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.

    PubMed 30359809

  • 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.

    PubMed 30336349

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample and actometer in people with Bipolar Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frank Bellivier, MD, PhD ((0)1 40 05 42 25 ext. +33, frank.bellivier@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Allele frequencies (time frame: All genotyping will be performed after 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627404, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.

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