The purpose of this study is to evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out parameter is the reduction of the total needed amount of diazepam for add-on treatment of acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria (AE) - reduction of alcohol withdrawal score over the days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
1500-2000 mg daily add-on or Placebo Diazepam as needed
1500-2000 mg daily add-on or Placebo Diazepam as needed
MLU Halle-Wittenberg
Halle, Sachen/Anhalt, Germany
Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie
Berlin, State of Berlin, Germany
Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus
Berlin, State of Berlin, Germany
Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte
Essen, Germany
To evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome in inpatients. The primary come-out parameter is the reduction of the amount of diazepam for add-on treatment of acute alcohol withdrawal
Time frame: during trial
Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days
Time frame: during trial
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Zentrum für Seelische Gesundheit
Rhede, Germany