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Completed

NCT Number: NCT00159120

Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.

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Key information

Conditions

Schizophrenia Mental Disorders Psychoses Psychotic 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

German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40629, Germany

About this study

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent
  • One year neuroleptic maintenance treatment
  • Reaching stable course

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

maintained antipsychotic treatment vs. stepwise drug discontinuation

Other

maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year

Primary outcomes

  1. relapse rate

    Time frame: 1 year

Secondary outcomes

  1. 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.
  • Ludwig-Maximilians - University of Munich
  • 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 Wuerzburg
  • Universität Duisburg-Essen

Registry information

Official study title

Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Jan 30, 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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