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Completed

NCT Number: NCT00159081

One Year Drug Treatment 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40629, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol, Risperidone (drug)

Drug

targeted dose of 2-4 mg/day over 1 year

Primary outcomes

  1. relapse rate

    Time frame: 1 year

Secondary outcomes

  1. course in psychopathology

    Time frame: 1 year

  2. social and cognitive functioning

    Time frame: 1 year

  3. side-effects

    Time frame: 1 year

  4. drop-out

    Time frame: 1 year

  5. quality of life

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Feb 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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