Condition category
Mental and Behavioural Disorders
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
19/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.eufest.nl

Contact information

Type

Scientific

Primary contact

Dr Han Boter

ORCID ID

Contact details

University Medical Centre Utrecht
Department of Psychiatry (A01.126)
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 90 46

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR25

Study information

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

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?

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia, schizophreniform, or schizoaffective disorder

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Amisulpride, Haloperidol, Olanzapine, Quetiapine, Ziprasidone

Primary outcome measures

Retention to allocated study drug, which is the time that the patient stays on the randomised drug within the study dose range.

Secondary outcome measures

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

Overall trial start date

01/12/2002

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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

Recruitment start date

01/12/2002

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, Sweden, Switzerland

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

European Group for Research in Schizophrenia (EGRIS) (Austria)

Sponsor details

Department of Biological Psychiatry
Innsbruck University Clinics
Anichstrasse 35
Innsbruck
6020
Austria

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

AstraZeneca (Netherlands)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Pfizer (Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Sanofi-Aventis (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Fleischhacker WW, Keet IP, Kahn RS, , The European First Episode Schizophrenia Trial (EUFEST): rationale and design of the trial., Schizophr. Res., 2005, 78, 2-3, 147-156, doi: 10.1016/j.schres.2005.06.004.

  2. Results

    Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IP, Gheorghe MD, Rybakowski JK, Galderisi S, Libiger J, Hummer M, Dollfus S, López-Ibor JJ, Hranov LG, Gaebel W, Peuskens J, Lindefors N, Riecher-Rössler A, Grobbee DE, , Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial., Lancet, 2008, 371, 9618, 1085-1097, doi: 10.1016/S0140-6736(08)60486-9.

  3. Results

    Davidson M, Galderisi S, Weiser M, Werbeloff N, Fleischhacker WW, Keefe RS, Boter H, Keet IP, Prelipceanu D, Rybakowski JK, Libiger J, Hummer M, Dollfus S, López-Ibor JJ, Hranov LG, Gaebel W, Peuskens J, Lindefors N, Riecher-Rössler A, Kahn RS, Cognitive effects of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: a randomized, open-label clinical trial (EUFEST)., Am J Psychiatry, 2009, 166, 6, 675-682, doi: 10.1176/appi.ajp.2008.08060806.

  4. Results

    Boter H, Derks EM, Fleischhacker WW, Davidson M, Kahn RS, , Generalizability of the results of efficacy trials in first-episode schizophrenia: comparisons between subgroups of participants of the European First Episode Schizophrenia Trial (EUFEST)., J Clin Psychiatry, 2010, 71, 1, 58-65, doi: 10.4088/JCP.08m04506yel.

  5. Results

    Volavka J, Czobor P, Derks EM, Bitter I, Libiger J, Kahn RS, Fleischhacker WW, , Efficacy of antipsychotic drugs against hostility in the European First-Episode Schizophrenia Trial (EUFEST)., J Clin Psychiatry, 2011, 72, 7, 955-961, doi: 10.4088/JCP.10m06529.

Additional files

Editorial Notes