drugset / Trial / NCT00159081
One Year Drug Treatment in First-Episode Schizophrenia
Phase 4
Completed
159 enrolled
Heinrich-Heine University, Duesseldorf
German Federal Ministry of Education and Research · collabGerman Research Network On Schizophrenia · collabHumboldt-Universität zu Berlin · collabJanssen-Cilag Ltd. · collabMainz University · collabMartin-Luther-Universität Halle-Wittenberg · collabRWTH Aachen University · collabUniversity Hospital Tuebingen · collabUniversity of Bonn · collabUniversity of Cologne · collabUniversity of Göttingen · collabUniversity of Jena · collabUniversity of Mannheim · collabUniversity of München · collabUniversity of Wuerzburg · collabUniversität Duisburg-Essen · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2000-11
- Primary completion
- 2005-06
- Completion
- 2005-06
Outcome
Missed primary endpoint
paper the hypothesized difference between risperidone and low-dose haloperidol regarding relapse prevention could not be supported for this sample of patients with first-episode schizophrenia. PMID 18052570 ↗
Publications
- 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Haloperidol | Other / unclassified | 2 mg | — |
| Subject | Haloperidol | Other / unclassified | 4 mg | — |
| Subject | Risperidone | Other / unclassified | 2 mg | — |
| Subject | Risperidone | Other / unclassified | 4 mg | — |