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

This study is currently recruiting participants.
Verified January 2014 by Centre Hospitalier Esquirol
Sponsor:
Information provided by (Responsible Party):
Philippe Nubukpo, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01491347
First received: December 12, 2011
Last updated: January 6, 2014
Last verified: January 2014

December 12, 2011
January 6, 2014
November 2011
November 2015   (final data collection date for primary outcome measure)
BDNF serum levels variations between alcohol withdrawal and 14-, 28- days, 2-, 4- and 6- months after in relation to abstinence at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01491347 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal
Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum

Non-Probability Sample

Subjects with alcohol dependance diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), and asking for alcohol withdrawal in hospitalization

Alcohol Dependence
Not Provided
alcohol dependent
Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
389
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Philippe Nubukpo, MD, PhD 0033555431374 philippe.nubukpo@ch-esquirol-limoges.fr
Contact: Murielle Girard, PhD 0033555431100 murielle.girard@ch-esquirol-limoges.fr
France
 
NCT01491347
2011-A00452-39
No
Philippe Nubukpo, Centre Hospitalier Esquirol
Centre Hospitalier Esquirol
Not Provided
Principal Investigator: Philippe Nubukpo, MD, PhD Centre Hospitalier Esquirol
Centre Hospitalier Esquirol
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP