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Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia

NCT ID: NCT00159133

Last Updated: 2008-01-30

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2006-06-30

Brief Summary

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Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

Detailed Description

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In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

Conditions

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Schizophrenia Psychoses

Keywords

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Schizophrenia first episode prodrome based early intervention antipsychotics - benzodiazepine maintenance treatment drug discontinuation

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

Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse

Group Type EXPERIMENTAL

antipsychotics vs. Lorazepam (Drugs)

Intervention Type DRUG

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

2

Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse

Group Type ACTIVE_COMPARATOR

antipsychotics vs. Lorazepam (Drugs)

Intervention Type DRUG

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

Interventions

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antipsychotics vs. Lorazepam (Drugs)

Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment

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

Ludwig-Maximilians - University of Munich

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 Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf

Locations

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German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf

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)

Related Links

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http://www.kompetenznetz-schizophrenie.de

Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia

Other Identifiers

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01GI 9932 - P 2.2.2.2

Identifier Type: -

Identifier Source: org_study_id