Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 12, 2011 | ||||||||
| Last Updated Date | April 19, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01491347 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal | ||||||||
| Official Title ICMJE | Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence | ||||||||
| 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. |
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| 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). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: serum |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 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 |
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| Condition ICMJE | Alcohol Dependence | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | alcohol dependent | ||||||||
| Publications * | 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. Epub 2011 Aug 16. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 205 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01491347 | ||||||||
| Other Study ID Numbers ICMJE | 2011-A00452-39 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Philippe Nubukpo, Centre Hospitalier Esquirol | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Esquirol | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Esquirol | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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