NCT02146963

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

May 22, 2014

Last Update Submit

January 30, 2017

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Frequency of the Bdnf gene Val/Val, Val/Met and Met/Met phenotypes as a function of relapse

    at the time of inclusion

Secondary Outcomes (3)

  • 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

  • existence of a psychiatric co-morbidity at the inclusion (major depression, schizophrenia, anxiety disorder)

    at the time of inclusion

  • presence of a psychiatric co-morbidity at 6 months after withdrawal (major depression, schizophrenia, anxiety disorder)

    6 month after alcohol withdrawal

Study Arms (1)

alcohol withdrawal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

alcohol-dependent subjects hospitalized for alcohol withdrawal

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87025, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Philippe Nubukpo, MD, PhD

    Centre Hospitalier Esquirol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 26, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

FR(1)