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 measure
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 (if study stopped)
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
Funders
Funder type
Industry
Funder name
AstraZeneca (Netherlands)
Alternative name(s)
AstraZeneca PLC
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Funder name
Pfizer (Netherlands)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list
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
-
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.
-
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.
-
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.
-
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.
-
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.