|- candidate number||0|
|- NTR Number||NTR25|
|- Date ISRCTN created||16-mei-2005|
|- date ISRCTN requested||12-apr-2005|
|- Date Registered NTR||2-mrt-2005|
|- Secondary IDs||N/A |
|- 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.
|- 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
|- Healt Condition(s) or Problem(s) studied||Schizophrenia, Schizophreniform disorder, Schizoaffective disorder|
|- Inclusion criteria||1. Diagnosis of schizophrenia;
2. Schizophreniform or schizoaffective disorder;
3. Age 18-40 years.
|- 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 antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime;
3. Intolerance to one of the drugs in this study;
4. The presence of one or more of the contraindications against any of the study drugs.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2002|
|- planned closingdate||1-dec-2006|
|- 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||Retention to allocated study drug, which is the time that the patient stays on the randomised drug within the study dose range. This outcome is assessed at regular time intervals until 12 months after recruitment.|
|- Secondary outcome||At regular time intervals patients are followed-up until 12 months after recruitment: psychopathology (positive symptoms, negative symptoms, depression, agitation-excitement, disorganisation), side effects (EPS side-effect profile, sexual side effects and weight gain), compliance, social needs, quality of life, substance abuse, neurocognitive functioning, and genetic determinants of response to antipsychotic drugs and natural history of schizophrenia.|
|- Trial web site||http://jc.med.uu.nl/eufest_demo/|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Han Boter|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Han Boter|
|- Sponsor/Initiator ||EGRIS (European Group for Research in Schizophrenia)|
(Source(s) of Monetary or Material Support)
|Pfizer, AstraZeneca, Sanofi-Aventis|
|- Publications||1. Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IPM, 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 for the EUFEST study group. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. The Lancet 2008; 371: 1085-1097.|
Fleischhacker WW, Keet IP, Kahn RS. The European First Episode
Schizophrenia Trial (EUFEST): Rationale and design of the trial.
Schizophr Res 2005;78:147-56.
|- Brief summary||In the European First Episode Schizophrenia Trial (EUFEST) we study the effectiveness of antipsychotic drugs in patients with recent onset schizophrenia. EUFEST assesses the effectiveness of a low dose of haloperidol versus regular doses of 4 second generation antipsychotics: amisulpride, olanzapine, quetiapine, and ziprasidone on loss of retention. We focus on the real world treatment of first episode patients by enrolling heterogeneous patient populations, including patients who show comorbid drug abuse or who are aggressive or suicidal or less likely to be compliant with treatment.
The principal investigators are Prof.dr. René S Kahn and Prof.dr. W Wolfgang Fleischhacker.|
|- Main changes (audit trail)|
|- RECORD||5-jul-2005 - 3-apr-2008|