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Endophenotype Characterization of a Family Psychiatric Disorder (EnBiGen)

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ClinicalTrials.gov Identifier: NCT02843997
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

Bipolar disorder is a chronic and frequent mood pathology, that impacts on emotional and socio-professional life of sick subjects, and also increase mortality by suicide. Suicide is considered as a bipolar disorder result.

The main goal of this study is the endophenotype characterization from a clinical and cognitive point of view, of a bipolar spectrum's disorder present in a family, and then highlight a mutation of one of the genes involved is this disorder.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Genetic: Endophenotype and sequencing Not Applicable

Detailed Description:

Heritability of bipolar disorder is now well established, but seems to be multifactorial in most of the cases.

The use of an endophenotype characterized in a family presenting numerous bipolar sufferers enable to reflect the expression of simpler genetic variants than those involved in the disease, and might enable the identification of genes involved in the etiopathogenesis of this endophenotype.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Endophenotype Characterization of a Family Psychiatric Disorder of the Bipolar Spectrum, With an Autosomal Dominant Expression
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Healthy volunteers
Members of a family
Genetic: Endophenotype and sequencing
Draw an endophenotype and genetic study




Primary Outcome Measures :
  1. Neuropsychological evaluations tests [ Time Frame: One day ]

    Neuropsychological evaluations (about one hour) :

    TMT (Trail Making Test) A and B, Stroop VFT (Visual Field Testing), DST (Dyslexia Screening Test) Tower of London test Hayling, CPT (continuous performance task) CVLT (California Verbal Learning Test) tests.


  2. Eye tracking. [ Time Frame: One hour ]

    The volunteer will follow an instruction according to the color seen on a screen.

    This instruction is to look at the side where there is a flashlight and to look at the opopsite if the light is unbroken.

    Mistakes will be count.


  3. Blood sampling [ Time Frame: 3 minutes ]
    Genetic sample for extraction of DNA.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Members of a family adult (more than 18 years)
  • Signed informed consents
  • Registered to a French social security or possesor of the European Health Insurance Card

Exclusion Criteria:

Clinical part :

  • Refusal to sign the participation study consent.
  • Organic affection likely to affect cognitive abilities and brain structures or acute decompensation of a bipolar disorder.

Genetic part :

  • Refusal to sign the genetic sample consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843997


Contacts
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Contact: Jérôme Holtzmann, Doctor 04 76 76 54 14 jholtzmann@chu-grenoble.fr
Contact: John Rendu, Doctor 04 76 76 55 73 jrendu@chu-grenoble.fr

Locations
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France
UniversityHospitalGrenoble Recruiting
La Tronche, France, 38700
Contact: Jérôme Holtzmann, Doctor    04 76 76 54 14    JHoltzmann@chu-grenoble.fr   
Contact: John Rendu    04 76 76 55 73    jrendu@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Jérôme Holtzmann, Doctor Grenoble Hospital University

Publications:
Chauvin, A. et al. Saccadic inhibition - A trait biomarker of bipolar disorder. 16th Annual conference of the International Society for Bipolar Disorder (2014).
Ferreira MA, O'Donovan MC, Meng YA, Jones IR, Ruderfer DM, Jones L, Fan J, Kirov G, Perlis RH, Green EK, Smoller JW, Grozeva D, Stone J, Nikolov I, Chambert K, Hamshere ML, Nimgaonkar VL, Moskvina V, Thase ME, Caesar S, Sachs GS, Franklin J, Gordon-Smith K, Ardlie KG, Gabriel SB, Fraser C, Blumenstiel B, Defelice M, Breen G, Gill M, Morris DW, Elkin A, Muir WJ, McGhee KA, Williamson R, MacIntyre DJ, MacLean AW, St CD, Robinson M, Van Beck M, Pereira AC, Kandaswamy R, McQuillin A, Collier DA, Bass NJ, Young AH, Lawrence J, Ferrier IN, Anjorin A, Farmer A, Curtis D, Scolnick EM, McGuffin P, Daly MJ, Corvin AP, Holmans PA, Blackwood DH, Gurling HM, Owen MJ, Purcell SM, Sklar P, Craddock N; Wellcome Trust Case Control Consortium. Collaborative genome-wide association analysis supports a role for ANK3 and CACNA1C in bipolar disorder. Nat Genet. 2008 Sep;40(9):1056-8. doi: 10.1038/ng.209.
WHO. The world health report 2001.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02843997     History of Changes
Other Study ID Numbers: 38RC14.321
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Grenoble:
Bipolar disorder
Endophenotype
Family
Autosomal dominant expression
Sequencing
Heritability

Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms