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

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University of Bonn
Humboldt-Universität zu Berlin
Ludwig-Maximilians - University of Munich
University of Göttingen
University of Cologne
Mainz University
University Hospital Tuebingen
Universität Duisburg-Essen
University of Mannheim
University of Jena
Martin-Luther-Universität Halle-Wittenberg
RWTH Aachen University
University of Wuerzburg
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00159120
First received: September 7, 2005
Last updated: January 28, 2008
Last verified: January 2008

September 7, 2005
January 28, 2008
November 2001
June 2006   (final data collection date for primary outcome measure)
relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
1 year relapse rate
Complete list of historical versions of study NCT00159120 on ClinicalTrials.gov Archive Site
  • psychopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • social and cognitive functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • side-effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • drop-out [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 1 year course regarding psychopathology
  • social and cognitive functioning
  • side-effects
  • drop-out
  • quality of life
Not Provided
Not Provided
 
Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia
Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Psychoses
Other: maintained antipsychotic treatment vs. stepwise drug discontinuation
maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
  • Active Comparator: 1
    further maintenance antipsychotic treatment and prodrome-based early intervention
    Intervention: Other: maintained antipsychotic treatment vs. stepwise drug discontinuation
  • Experimental: 2
    stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention
    Intervention: Other: maintained antipsychotic treatment vs. stepwise drug discontinuation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00159120
01GI 9932 - P 2.2.2.1 / 2
Yes
Not Provided
Heinrich-Heine University, Duesseldorf
  • German Federal Ministry of Education and Research
  • German Research Network On Schizophrenia
  • Janssen-Cilag Ltd.
  • University of Bonn
  • Humboldt-Universität zu Berlin
  • Ludwig-Maximilians - University of Munich
  • University of Göttingen
  • University of Cologne
  • Mainz University
  • University Hospital Tuebingen
  • Universität Duisburg-Essen
  • University of Mannheim
  • University of Jena
  • Martin-Luther-Universität Halle-Wittenberg
  • RWTH Aachen University
  • University of Wuerzburg
Study Chair: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
Heinrich-Heine University, Duesseldorf
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP