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22 May 2012
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| [ Print-friendly version ] |
| The European First Episode Schizophrenia Trial (EUFEST): Comparison of outcome in first episode schizophrenia with different low dose antipsychotic drug regimens |
| ISRCTN | ISRCTN68736636 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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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| © 2012 ISRCTN unless otherwise stated. | |
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