One Year Drug Treatment in First-Episode Schizophrenia

February 6, 2008 updated by: Heinrich-Heine University, Duesseldorf

One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Duesseldorf, North Rhine-Westphalia, Germany, 40629
        • Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent

Exclusion Criteria:

  • Residence outside of the catchment area
  • Legal reasons
  • Insufficient knowledge of the German language
  • Substance abuse or addiction
  • Pregnancy
  • Serious physical illness
  • Organic brain disease
  • Contraindication to neuroleptic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Maintenance antipsychotic treatment with risperidone
Drug: Haloperidol, Risperidone (drug)
targeted dose of 2-4 mg/day over 1 year
Active Comparator: 2
Maintenance antipsychotic treatment with haloperidol in low-dose
Drug: Haloperidol, Risperidone (drug)
targeted dose of 2-4 mg/day over 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
relapse rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 1 year
1 year
social and cognitive functioning
Time Frame: 1 year
1 year
side-effects
Time Frame: 1 year
1 year
drop-out
Time Frame: 1 year
1 year
course in psychopathology
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

German Federal Ministry of Education and Research
University of Cologne
RWTH Aachen University
University of Jena
University Hospital Tuebingen
Universität Duisburg-Essen
Martin-Luther-Universität Halle-Wittenberg
University of Wuerzburg
Janssen-Cilag Ltd.
University of Mannheim
University of Göttingen
Humboldt-Universität zu Berlin
University of Bonn
University of München
Mainz University
German Research Network On Schizophrenia

Investigators

  • Study Chair: Wolfgang Gaebel, Professor, Department of Psychiatry and Psychotherapy, University of Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

February 7, 2008

Last Update Submitted That Met QC Criteria

February 6, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01GI 9932 - P 2.2.2.1 / 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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