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 |
| Secondary identifying numbers | NTR25 |
- 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
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
| Study design | Multicentre, randomised active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2002 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
3508 GA
Netherlands
Sponsor information
European Group for Research in Schizophrenia (EGRIS) (Austria)
Research organisation
Research organisation
Department of Biological Psychiatry
Innsbruck University Clinics
Anichstrasse 35
Innsbruck
6020
Austria
Funders
Funder type
Industry
AstraZeneca (Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Pfizer (Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Sanofi-Aventis (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/10/2005 | Yes | No | |
| 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 |
