Optimization of Acute Treatment in First Episode Schizophrenia

• Status: Unknown status
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Department of Psychiatry University FU Berlin; Department of Psychiatry University of Bonn; German Research Network On Schizophrenia; Heinrich-Heine University, Duesseldorf; Janssen-Cilag Ltd.; Mainz University; Martin-Luther-Universität Halle-Wittenberg; RWTH Aachen University; Universität Duisburg-Essen; University Hospital Tuebingen; University of Cologne; University of Göttingen; University of Jena; University of Mannheim; University of Wuerzburg
• Treatments: Haloperidol; Haloperidol decanoate; Risperidone

Criteria

Inclusion Criteria:

• ICD-10 criteria for first episode schizophrenia

• age between 18 and 55

• informed consent

Exclusion Criteria:

• legal reasons

• insufficient knowledge of the german language

• substance abuse or addiction

• pregnancy

• serious physical illness

• organic brain disease

• contraindication to neuroleptic treatment