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

This study has been completed.

First Received: September 7, 2005 Last Updated: January 28, 2008 History of Changes

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 Univeristat 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

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 IV

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia

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
1: Active Comparator 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
2: Experimental 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:

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, North Rhine-Westphalia
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

Univeristat 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

This link exits the ClinicalTrials.gov site

Publications:

Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40.

Study ID Numbers:	01GI 9932 - P 2.2.2.1 / 2
Study First Received:	September 7, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00159120 History of Changes
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

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 06, 2009