Ignite Creation Date:
2024-05-06 @ 12:07 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01491347
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2011-12-12
Brief Title:
Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal
Sponsor:
Centre Hospitalier Esquirol
Organization:
Centre Hospitalier Esquirol
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Hamiltonanxiety scale HAM-A the Obsessive Compulsive Drinking Scale OCDS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None