Endophenotype Characterization of a Family Psychiatric Disorder

Healthy Volunteer Clinical Trial

— EnBiGen  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02843997
• Other study ID #: 38RC14.321
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2016
• Last updated: July 22, 2016
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: July 2016
• Source: University Hospital, Grenoble
• Contact: Jérôme Holtzmann, Doctor
• Phone: 04 76 76 54 14
• Email: jholtzmann[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Mental Disorders
• Problem Behavior

Intervention

Genetic:
• Endophenotype and sequencing
Draw an endophenotype and genetic study

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (55)

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* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological evaluations tests	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	No
Primary	Eye tracking.	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	No
Primary	Blood sampling	Genetic sample for extraction of DNA.	3 minutes	No