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

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

January 28, 2008

Start Date ^ICMJE

November 2001

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

1 year relapse rate

Change History

Complete list of historical versions of study NCT00159120 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

1 year course regarding psychopathology
social and cognitive functioning
side-effects
drop-out
quality of life

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Psychoses

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00159120

Other Study ID Numbers ^ICMJE

01GI 9932 - P 2.2.2.1 / 2

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Heinrich-Heine University, Duesseldorf

Collaborators ^ICMJE

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 ^ICMJE

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

Information Provided By

Heinrich-Heine University, Duesseldorf

Verification Date

January 2008

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

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