Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal
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Purpose
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.
| Condition |
|---|
|
Alcohol Dependence |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence |
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
serum
| Estimated Enrollment: | 205 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| alcohol dependent |
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 transferin (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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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
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
Contacts and Locations| Contact: Philippe Nubukpo, MD, PhD | 0033555431374 | philippe.nubukpo@ch-esquirol-limoges.fr |
| Contact: Murielle Girard, PhD | 0033555431100 | murielle.girard@ch-esquirol-limoges.fr |
| France | |
| Clinique Saint Maurice | Not yet recruiting |
| La Jonchère, France, 87340 | |
| Contact: Denis Schadler, MD 0033555395959 denis.schadler@wanadoo.fr | |
| Principal Investigator: Denis Schadler, MD | |
| Centre Hospitalier Esquirol | Recruiting |
| Limoges, France, 87000 | |
| Contact: Philippe Nubukpo, MD, PhD 0033555431374 philippe.nubukpo@ch-esquirol-limoges.fr | |
| Contact: Murielle Girard, PhD 0033555431100 murielle.girard@ch-esquirol-limoges.fr | |
| Centre Hospitalier Univsersitaire de Limoges | Not yet recruiting |
| Limoges, France, 87000 | |
| Contact: Maryline Debette-Gratien, MD 0033555056621 gratien-marie@orange.fr | |
| Principal Investigator: Maryline Debette-Gratien, MD | |
| Centre Hospitalier de Vauclaire | Not yet recruiting |
| Montpon Menesterol, France, 24700 | |
| Contact: Pierre-Louis Diennet, MD 0033553056680 pierre-louis.diennet@ch-montpon.fr | |
| Principal Investigator: Pierre-Louis Diennet, MD | |
| Principal Investigator: | Philippe Nubukpo, MD, PhD | Centre Hospitalier Esquirol |
More Information
Publications:
| Responsible Party: | Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol |
| ClinicalTrials.gov Identifier: | NCT01491347 History of Changes |
| Other Study ID Numbers: | 2011-A00452-39 |
| Study First Received: | December 12, 2011 |
| Last Updated: | April 19, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Esquirol:
|
BDNF withdrawal alcohol psychiatry |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ethanol Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013