One Year Drug Treatment in First-Episode Schizophrenia

NCT ID: NCT00159081

Last Updated: 2008-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2005-06-30

Brief Summary

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Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

Detailed Description

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The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Maintenance antipsychotic treatment with risperidone

Group Type EXPERIMENTAL

Haloperidol, Risperidone (drug)

Intervention Type DRUG

targeted dose of 2-4 mg/day over 1 year

2

Maintenance antipsychotic treatment with haloperidol in low-dose

Group Type ACTIVE_COMPARATOR

Haloperidol, Risperidone (drug)

Intervention Type DRUG

targeted dose of 2-4 mg/day over 1 year

Interventions

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Haloperidol, Risperidone (drug)

targeted dose of 2-4 mg/day over 1 year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

German Research Network On Schizophrenia

NETWORK

Sponsor Role collaborator

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

University of Bonn

OTHER

Sponsor Role collaborator

Humboldt-Universität zu Berlin

OTHER

Sponsor Role collaborator

University of München

OTHER

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role collaborator

University of Cologne

OTHER

Sponsor Role collaborator

Mainz University

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role collaborator

University of Mannheim

OTHER

Sponsor Role collaborator

University of Jena

OTHER

Sponsor Role collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role collaborator

University of Wuerzburg

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Principal Investigators

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Wolfgang Gaebel, Professor

Role: STUDY_CHAIR

Department of Psychiatry and Psychotherapy, University of Duesseldorf

Locations

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Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1007/s00406-004-0509-y.

Reference Type BACKGROUND
PMID: 15146342 (View on PubMed)

Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Jockers-Scherubl MC, Kuhn KU, Lemke M, Bechdolf A, Bender S, Degner D, Schlosser R, Schmidt LG, Schmitt A, Jager M, Buchkremer G, Falkai P, Klingberg S, Kopcke W, Maier W, Hafner H, Ohmann C, Salize HJ, Schneider F, Moller HJ; German Study Group on First-Episode Schizophrenia. Maintenance treatment with risperidone or low-dose haloperidol in first-episode schizophrenia: 1-year results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2007 Nov;68(11):1763-74. doi: 10.4088/jcp.v68n1116.

Reference Type RESULT
PMID: 18052570 (View on PubMed)

Related Links

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http://www.kompetenznetz-schizophrenie.de

Click here for more information about this study: One year maintenance treatment with low dose Haloperidol vs. Risperidone in first-episode schizophrenia

Other Identifiers

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01GI 9932 - P 2.2.2.1 / 1

Identifier Type: -

Identifier Source: org_study_id

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