Endophenotype Characterization of a Family Psychiatric Disorder (EnBiGen)

July 22, 2016 updated by: University Hospital, Grenoble

Endophenotype Characterization of a Family Psychiatric Disorder of the Bipolar Spectrum, With an Autosomal Dominant Expression

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy volunteers
Members of a family
Genetic: Endophenotype and sequencing
Draw an endophenotype and genetic study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One day
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.
One hour
Blood sampling
Time Frame: 3 minutes
Genetic sample for extraction of DNA.
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jérôme Holtzmann, Doctor, Grenoble Hospital University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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