Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal

Completed

• Conditions: Alcohol Dependence

• Registration Number: NCT01491347
• Lead Sponsor: Centre Hospitalier Esquirol

Brief Summary

Alcohol dependence is accompanied by several neurological mechanisms involving neuronal plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis.

The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a greater extent in subjects who had remained abstinent at 6 months after withdrawal than in subjects who had relapse.

To verify if the BDNF serum levels variation is linked to the way that abstinence is installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects at the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its evolution in relation to alcohol consumption, and other clinical characteristics : depression intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity. Monitoring serum BDNF concentrations in link with other clinical data could help to characterize alcohol dependence profiles in clinical practice, help predict relapses, and assist in adjusting care to prevent difficulties in alcohol withdrawal.

Detailed Description

A total of 205 patients will be recruited at their hospitalization time for alcohol withdrawal during a 18 months period. The follow-up at 14, 28 days, 2, 4, 6 months after alcohol withdrawal will assess their BDNF serum levels, the levels of carbohydrate deficient transferrin (CDT), gamma glutamyl transferase (GGT), urinary ethylglucuronide (EtG), and the scores to the Beck Depression Inventory (BDI), the Montgomery Asberg depression scale (MADRS), the Hamilton'anxiety scale (HAM-A), the Obsessive Compulsive Drinking Scale (OCDS).

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

• Diagnosis of alcohol dependence according to the DSM-IV-TR
• Request for withdrawal

Exclusion Criteria

• Age < 18 years
• Psychiatric co-morbidity in an evoluting stage and predominant on the addiction trouble
• Characterized (diagnosed) neurological co-morbidity
• Severe somatic pathology and / or with fatal predicted outcome in the year (cancer...)
• Inability to answer the questionnaires
• pregnancy
• neuroleptic or antidepressant treatment established for less than 3 months
• anti-retroviral treatment
• absence of consent, judiciary protection, hospitalization under constraint, - absence of health insurance.
• Residence at more than 80 km from the study center
• Participation to an other biomedical study during the 6 months of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BDNF serum levels variations between alcohol withdrawal and 14-, 28- days, 2-, 4- and 6- months after in relation to abstinence at 6 months.	6 months

Secondary Outcome Measures

Name	Time	Method
Search of a correlation between serum BDNF levels and alcohol consumption marker (CDT), GGT, EtG at 28 days 2, 4, and 6 months after alcohol withdrawal.	6 months
Search of a correlation between serum BDNF levels and the scores to psychometric scales : BDI, MADRS, HAM-A, OCDS, at 28 days 2, 4, and 6 months after alcohol withdrawal.	6 months

Trial Locations

Locations (4)

Clinique Saint Maurice; 🇫🇷 La Jonchère, France

Centre Hospitalier Esquirol; 🇫🇷 Limoges, France

Centre Hospitalier La Vallette; 🇫🇷 Saint-Vaury, France

Centre Hospitalier de Vauclaire; 🇫🇷 Montpon Menesterol, France