The European First Episode Schizophrenia Trial (EUFEST): Comparison of outcome in first episode schizophrenia with different low dose antipsychotic drug regimens

ISRCTN	ISRCTN68736636
DOI	https://doi.org/10.1186/ISRCTN68736636
Protocol serial number	NTR25
Sponsor	European Group for Research in Schizophrenia (EGRIS) (Austria)
Funders	AstraZeneca (Netherlands), Pfizer (Netherlands), Sanofi-Aventis (Netherlands)

Submission date: 16/05/2005
Registration date: 16/05/2005
Last edited: 19/04/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Han Boter
Scientific

University Medical Centre Utrecht
Department of Psychiatry (A01.126)
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 250 90 46

Study information

Primary study design	Interventional
Study design	Multicentre, randomised active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	The European study of the effectiveness of haloperidol, amisulpride, olanzapine, quetiapine, and ziprasidone on loss of retention in first episode schizophrenia
Study acronym	EUFEST
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Amisulpride, Haloperidol, Olanzapine, Quetiapine, Ziprasidone
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.
Key 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
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key 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.
Key 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
Date of first enrolment	01/12/2002
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

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

Study participating centre

University Medical Centre Utrecht

Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/03/2008		Yes	No
Results article	results	01/06/2009		Yes	No
Results article	results	01/01/2010		Yes	No
Results article	results	01/07/2011		Yes	No
Protocol article	protocol	15/10/2005		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes