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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 Hospital, 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
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Psychoses
 Other: maintained antipsychotic treatment vs. stepwise drug discontinuation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 71
Study Start Date: November 2001
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
further maintenance antipsychotic treatment and prodrome-based early intervention
 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
Experimental: 2
stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159120

Locations
Germany
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40629
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University Hospital, 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
Investigators
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
  More Information

Additional Information:
Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00159120     History of Changes
Other Study ID Numbers: 01GI 9932 - P 2.2.2.1 / 2
Study First Received: September 7, 2005
Last Updated: January 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
Schizophrenia
first episode
neuroleptic maintenance treatment
drug discontinuation
prodrome based early intervention

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013