DEPRESSION MedDRA version: 9.1 Level: LLT Classification code 10000340 Term: Abstains from alcohol
Conditions
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients attending the clinical department of Psychiatry Institute of A. Gemelli Hospital, Catholic University of Sacred Heart, in Rome with - diagnosis of alcohol dependence according to DSM IV-TR guide-lines - recently carried out detoxification from alcohol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - liver insufficiency - kidney insufficiency - important coagulation failure - anticoagulant therapy - concomitant treatment with other psychoactive drugs, than allowed ones - pregnancy and lactation - presence of psychiatric disorders psychotic disorders severely interfering with the evaluation - history of severe adverse events or hypersensitivity to the use of disulfiram or omega-3 P.U.F.A. Benzodiazepine until maximum dosage of diazepam 25mg/d or lorazepam 2,5mg /d or equivalent dosage of other benzodiazepine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of polyunsatured fatty acids omega-3 consumption on craving and psychiatric symptoms in alcoholic patients after detoxification;Secondary Objective: ND;Primary end point(s): Primary Outcomes - Alcoholic Abstinence - Craving reduction | — |
Countries
Italy
Outcome results
None listed