Optimization of Acute Treatment in First Episode Schizophrenia

NCT00157378 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2005-09-12

No results posted yet for this study

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).

Conditions

  • Schizophrenia, First-Episode

Interventions

DRUG

Risperidone, Haloperidol

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY
  • German Research Network On Schizophrenia

    collaborator NETWORK
  • Department of Psychiatry University of Bonn

    collaborator OTHER
  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER
  • Department of Psychiatry University FU Berlin

    collaborator OTHER
  • University of Göttingen

    collaborator OTHER
  • University of Cologne

    collaborator OTHER
  • Mainz University

    collaborator OTHER
  • University Hospital Tuebingen

    collaborator OTHER
  • Universität Duisburg-Essen

    collaborator OTHER
  • University of Mannheim

    collaborator OTHER
  • University of Jena

    collaborator OTHER
  • Martin-Luther-Universität Halle-Wittenberg

    collaborator OTHER
  • RWTH Aachen University

    collaborator OTHER
  • University of Wuerzburg

    collaborator OTHER
  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Hans-Jürgen Möller, Professor · Department of Psychiatry, Ludwig-Maximilians-University Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Completion
2004-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157378 on ClinicalTrials.gov