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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| German Research Network On Schizophrenia | NETWORK |
| Janssen-Cilag Ltd. | INDUSTRY |
| University of Bonn |
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Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.
The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Maintenance antipsychotic treatment with risperidone |
|
| 2 | Active Comparator | Maintenance antipsychotic treatment with haloperidol in low-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol, Risperidone (drug) | Drug | targeted dose of 2-4 mg/day over 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| relapse rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| course in psychopathology | 1 year | |
| social and cognitive functioning | 1 year | |
| side-effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Gaebel, Professor | Department of Psychiatry and Psychotherapy, University of Duesseldorf | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University | Düsseldorf | North Rhine-Westphalia | 40629 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15146342 | Background | Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40. doi: 10.1007/s00406-004-0509-y. | |
| 18052570 |
| Label | URL |
|---|---|
| Click here for more information about this study: One year maintenance treatment with low dose Haloperidol vs. Risperidone in first-episode schizophrenia | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D018967 | Risperidone |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011744 | Pyrimidinones |
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| OTHER |
| Humboldt-Universität zu Berlin | OTHER |
| University of München | OTHER |
| University of Göttingen | OTHER |
| University of Cologne | OTHER |
| Mainz University | OTHER |
| University Hospital Tuebingen | OTHER |
| Universität Duisburg-Essen | OTHER |
| University of Mannheim | OTHER |
| University of Jena | OTHER |
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
| RWTH Aachen University | OTHER |
| University of Wuerzburg | OTHER |
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| 1 year |
| drop-out | 1 year |
| quality of life | 1 year |
| Result |
| Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Jockers-Scherubl MC, Kuhn KU, Lemke M, Bechdolf A, Bender S, Degner D, Schlosser R, Schmidt LG, Schmitt A, Jager M, Buchkremer G, Falkai P, Klingberg S, Kopcke W, Maier W, Hafner H, Ohmann C, Salize HJ, Schneider F, Moller HJ; German Study Group on First-Episode Schizophrenia. Maintenance treatment with risperidone or low-dose haloperidol in first-episode schizophrenia: 1-year results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2007 Nov;68(11):1763-74. doi: 10.4088/jcp.v68n1116. |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |