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The European First Episode Schizophrenia Trial (EUFEST): Comparison of outcome in first episode schizophrenia with different low dose antipsychotic drug regimens
ISRCTN ISRCTN68736636
DOI 10.1186/ISRCTN68736636
ClinicalTrials.gov identifier
EudraCT number
Public title The European First Episode Schizophrenia Trial (EUFEST): Comparison of outcome in first episode schizophrenia with different low dose antipsychotic drug regimens
Scientific title The European study of the effectiveness of haloperidol, amisulpride, olanzapine, quetiapine, and ziprasidone on loss of retention in first episode schizophrenia
Acronym EUFEST
Serial number at source NTR25
Study hypothesis What is the effectiveness of low doses of haloperidol and regular doses of amisulpride, olanzapine, quetiapine, and ziprasidone on (loss of) one year retention in patients with recent onset of schizophrenia, schizoaffective, and schizophreniform disorder?
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Multicentre, randomised active controlled, parallel group trial
Countries of recruitment Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, Sweden, Switzerland
Disease/condition/study domain Schizophrenia, schizophreniform, or schizoaffective disorder
Participants - inclusion criteria 1. Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
2. Age 18 - 40 years

We will include an unselected group of 500 patients in 13 European countries (Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Italy, The Netherlands, Poland, Romania, Spain, Sweden, and Switzerland) and Israel, with a total of 49 participating sites.
Participants - exclusion criteria 1. A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years
2. Prior use of anti-psychotic medication longer than an episode of two weeks in the previous year and/or six weeks lifetime
3. Intolerance to one of the drugs in this study
4. The presence of one or more of the contra-indications against any of the study drugs
Anticipated start date 01/12/2002
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants 500
Interventions Drug: Amisulpride 200 - 800 mg/day
Drug: Haloperidol 1 - 4 mg/day
Drug: Olanzapine 5 - 20 mg/day
Drug: Quetiapine 200 - 750 mg/day
Drug: Ziprasidone 40 - 160 mg/day
Primary outcome measure(s) Retention to allocated study drug, which is the time that the patient stays on the randomised drug within the study dose range.
Secondary outcome measure(s) At regular time intervals patients are followed-up until 12 months after recruitment:
1. Psychopathology - positive symptoms, negative symptoms, depression, agitation-excitement, disorganisation
2. Side effects - extrapyramidal symptoms (EPS) side-effect profile, sexual side effects and weight gain
3. Compliance
4. Social needs
5. Quality of life
6. Substance abuse
7. Neurocognitive functioning
8. Genetic determinants of response to antipsychotic drugs
9. Natural history of schizophrenia
Sources of funding 1. AstraZeneca (Netherlands)
2. Pfizer (Netherlands)
3. Sanofi-Aventis (Netherlands)
Trial website http://www.eufest.nl
Publications 1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16055308
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18374841
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19369319
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19852905
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21824456
Contact name Dr  Han  Boter
  Address University Medical Centre Utrecht
Department of Psychiatry (A01.126)
P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Tel +31 (0)30 250 90 46
  Fax +31 (0)30 250 54 43
  Email
Sponsor European Group for Research in Schizophrenia (EGRIS) (Austria)
  Address Department of Biological Psychiatry
Innsbruck University Clinics
Anichstrasse 35
  City/town Innsbruck
  Zip/Postcode 6020
  Country Austria
Date applied 16/05/2005
Last edited 19/04/2012
Date ISRCTN assigned 16/05/2005
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