The European First Episode Schizophrenia Trial (EUFEST): Rationale and design of the trial

Fleischhacker, W. Wolfgang; Keet, Ireneus P.M.; Kahn, René S.; EUFEST Steering Committee,

doi:10.1016/j.schres.2005.06.004

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Volume 78, Issue 2 , Pages 147-156, 15 October 2005

The European First Episode Schizophrenia Trial (EUFEST): Rationale and design of the trial

W. Wolfgang Fleischhacker
- Department of Biological Psychiatry, Medical University Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria
- Corresponding author. Tel.: +43 512 504 23669; fax: +43 512 504 25267.
Ireneus P.M. Keet
- Department of Psychiatry, Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht, The Netherlands
René S. Kahn
- Department of Psychiatry, Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht, The Netherlands
EUFEST Steering Committee
- The EUFEST Steering Committee: Austria: W. Wolfgang Fleischhacker, Principal Investigator (PI), Martina Hummer, Country Coordinator (CC) Department of Biological Psychiatry, Medical University Innsbruck, Innsbruck. Belgium: Jozef Peuskens (CC), Universitair Centrum St.-Jozef, Kortenberg. Bulgaria: Luchezar G. Hranov (CC ), University Hospital of Neurology and Psychiatry “St. Naum”, Sofia. Czech Republic: Jan Libiger (CC), Psychiatric Clinic and Department of Psychiatry, Charles University, Hradec Kralové. France: Sonja Dollfus (CC), Centre Esquirol-CHU de Caen, Caen Cedex. Germany: Wolfgang Gaebel (CC), Rheinische Kliniken Düsseldorf, Düsseldorf. Israel: Michael Davidson (CC), Sheba Medical Center, Tel Hashomer. Italy: Silvana Galderisi (CC), Department of Psychiatry, University of Naples SUN, Naples. Netherlands: René S. Kahn, Principal Investigator (PI) and Country coordinator (CC), University Medical Center Utrecht, Utrecht. I.P.M. Keet (Trial Co-ordinator until July 2004), Han Boter (current Trial Co-ordinator), University Medical Center Utrecht, Utrecht. Poland: Janusz Rybakowski (CC), Karol Marcinkowski University of Medical Sciences, Poznan. Romania: Mihai Gheorghe (CC), Central Military Hospital, Psychiatric Department, Bucharest. Spain: Juan-Jose Lopez Ibor (CC), Hospital Universitario San Carlos, Madrid. Sweden: Goran Sedvall (CC), Inst. Of Clinical Neuroscience, Psychiatry Section, Stockholm. Switzerland: Anita Riecher-Rössler (CC), Psychiatrische Universitätspoliklinik, Basel.

Received 12 May 2005; received in revised form 2 June 2005; accepted 3 June 2005.

Abstract

Background

Most studies comparing second generation antipsychotics with classical neuroleptics have been conducted in more or less chronic schizophrenia patients. Such studies were usually conducted in highly selected samples, and were generally designed and financed by the manufacturer of the drug tested. These and other facts have stimulated discussions regarding the effectiveness of the new generation of antipsychotics.

Aims

The aim of the European First Episode Schizophrenia Trial (EUFEST) is to compare treatment with amisulpride, quetiapine, olanzapine and ziprasidone to a low dose of haloperidol in an unselected sample of first episode schizophrenia patients with minimal prior exposure to antipsychotics.

Methods

500 patients between the ages of 18–40 meeting DSM-IV criteria for schizophrenia, schizoaffective disorder or schizophreniform disorder are randomly allocated to one year of treatment with one of the drugs under study. The primary outcome measure is retention in treatment, defined as time to discontinuation of study drug. Loss of retention can be the result of insufficient clinical effect, or lack of tolerability or acceptance. Secondary measures include changes in different dimensions of psychopathology, side effects, compliance, social needs, quality of life, substance abuse and cognitive functions.

Conclusions

At present, more than 400 patients have been recruited and randomized in the following countries: Austria, Belgium, Bulgaria, Czech Republic, Germany, France, Israel, Italy, the Netherlands, Poland, Rumania, Spain, Sweden and Switzerland: The study should be finished by the end of 2006 and it is expected that results will yield relevant clinical information with regard to the effectiveness of the second generation antipsychotics. This effort represents the first independently designed trans-European schizophrenia treatment trial.

Keywords: Schizophrenia, First-episode, Antipsychotics, Second generation, Atypical, Clinical trial, Neuroleptics