detoxified alcohol dependent outpatients
Conditions
Interventions
Trade Name: Keppra
Product Name: Keppra
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Sponsors
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ages eligible for study 18-70 years meets criteria for alcohol dependence according to DSM-IV/ICD-10 detoxified alcohol dependent patients able to provide a written informed consent able to follow verbal and written instruction (incl. sufficient knowledge of German language)av have a negative urine drug screen for benzodiazepines and opiates 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: alcohol withdrawal syndrome beginning or existing • Simultaneous one ambulatory or stationary curing therapy, not however participation in groups of self-helps •Specific ones behavior or "tiefenpsychologsiche" single therapy or manual-led group therapies parallel to the clinical study • any further substance dependence except nicotine- and/or coffeinedependence. A Substanzabusus according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason. • Ideopathi epilepsy, not however admitted alcohol withdrawal convulsions • Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not however alcohol-associated neurological disturbances, e.g. polyneuropathia • current co-medication by means of medicines, which can affect significantly withdrawal symptoms or craving or promote the abstinence,e.g. benzodiazepines, antiepileptics, neuroleptics, • Contraindications or heavy side effects in relation to the study medication, or hypersensitivity opposite Pyrrolidonderivate • Pregnancy or quiet time or insufficient contrazeption • Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV • Acute suizidality, not convincingly arrangementable • Weight internal illnesses, e.g. pankreatite, pneumonia, cardiac infarct, gastrointerstinale bleedings etc.) • Weight kidney damage (starting from dekompensierter retention - stage 3 after that national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh Score with living ore erring trousers) • Simultaneous participation or within the last 4 weeks at another clinical study, however does not exist an exclusion with previous participation in the decontamination study with Keppra ® (Keppra 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: investigate in the efficacy and safety of levetiracetam versus placebo to prevent relapse in alcohol dependency;Secondary Objective: craving, drop-out-rate, sleeping quality, frequence of lapses, time to first drinking, life quality, changing in HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, SCL-90.;Primary end point(s): With the occurrence one of the exclusion criteria and/or with a heavy relapse, defines for men: at least 5 standard drinks, for women: at least 4 standard drinks over 2 days and/or easy | — |
Countries
Germany
Outcome results
None listed