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NCT02146963 Clinical Trial

Study of the BDNF-Val66Met Polymorphism in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

Alcohol Dependence Clinical Trial

Official title:
Study of the BDNF- Val66Met Polymorphism in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02146963
Other study ID # 2014-A00613-44
Secondary ID
Status Completed
Phase N/A
First received May 22, 2014
Last updated January 30, 2017
Start date May 2014
Est. completion date April 2016

Study information
Verified date January 2017
Source Centre Hospitalier Esquirol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

The purpose of this study is to evaluate the Bdnf gene - Val66Met polymorphism in subjects with alcohol dependence according to their alcohol consumption status 6 months after withdrawal (relapse or abstinence), in relation to the presence of psychiatric co-morbidities.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)

- criteria from the main study

Exclusion Criteria:

- criteria from the main study

- released or out from the main study before the follow-up at 4 months after withdrawal

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Esquirol Limoges

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier Esquirol Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of the Bdnf gene Val/Val, Val/Met and Met/Met phenotypes as a function of relapse at the time of inclusion
Secondary serum BDNF levels variations between inclusion and 6 months later (or 4 months if the participants does not come for the 4 months-follow-up). 6 months after alcohol withdrawal
Secondary existence of a psychiatric co-morbidity at the inclusion (major depression, schizophrenia, anxiety disorder) at the time of inclusion
Secondary presence of a psychiatric co-morbidity at 6 months after withdrawal (major depression, schizophrenia, anxiety disorder) 6 month after alcohol withdrawal
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