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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.
Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of the Abstinenz up to the heavy relapse.
Secondary objective size are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam (Keppra) | Drug | levetiracetam daily application 1500-2000 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos | During and after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 1 Time up to first drinking | During treatment | |
| 2 cumulative Time of do not drinking over the study duration | during treatment | |
| 3 Frequency of Lapses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schaefer, MD | Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Nürnberg Nord | Nuremberg | Bavaria | 90419 | Germany | ||
| Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16702910 | Background | Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol. 2006 Jun;26(3):347-9. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available. | |
| 22722516 | Derived | Richter C, Effenberger S, Bschor T, Bonnet U, Haasen C, Preuss UW, Heinz A, Forg A, Volkmar K, Glauner T, Schaefer M. Efficacy and safety of levetiracetam for the prevention of alcohol relapse in recently detoxified alcohol-dependent patients: a randomized trial. J Clin Psychopharmacol. 2012 Aug;32(4):558-62. doi: 10.1097/JCP.0b013e31825e213e. |
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| Placebo | Drug | Sugar Pill |
|
| during treatment |
| Tolerability of the study medication | during treatment |
| Drop Out rate | during treatment |
| Side effects | during treatment |
| Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90 | during treatment |
| Quality of life | during treatment |
| Bochum |
| North Rhine-Westphalia |
| 44791 |
| Germany |
| Klinik und Poliklinik für Psychiatrie und Psychotherapie | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte | Essen | North Rhine-Westphalia | 45136 | Germany |
| Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle | Halle | Saxony-Anhalt | 06097 | Germany |
| Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie | Berlin | State of Berlin | 10117 | Germany |
| PUK Charité im SHK | Berlin | State of Berlin | 10559 | Germany |
| Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik | Berlin | State of Berlin | 12099 | Germany |
| Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin | Berlin | State of Berlin | 13347 | Germany |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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