drugset / Trial / NCT00157378
Optimization of Acute Treatment in First Episode Schizophrenia
Phase 4
Unknown
300 enrolled
Ludwig-Maximilians - University of Munich
Department of Psychiatry University FU Berlin · collabDepartment of Psychiatry University of Bonn · collabGerman Research Network On Schizophrenia · collabHeinrich-Heine University, Duesseldorf · collabJanssen-Cilag Ltd. · collabMainz University · collabMartin-Luther-Universität Halle-Wittenberg · collabRWTH Aachen University · collabUniversity Hospital Tuebingen · collabUniversity of Cologne · collabUniversity of Göttingen · collabUniversity of Jena · collabUniversity of Mannheim · collabUniversity of Wuerzburg · collabUniversität Duisburg-Essen · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).
Timeline
- Start
- 2000-11
- Primary completion
- —
- Completion
- 2004-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Haloperidol | Other / unclassified | 2 mg | — |
| Subject | Haloperidol | Other / unclassified | 8 mg | — |
| Subject | Risperidone | Other / unclassified | 2 mg | — |
| Subject | Risperidone | Other / unclassified | 8 mg | — |