No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
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.
Background 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.
Study objective
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?
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
P.O. Box 85500
Han Boter
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509046
h.boter@azu.nl
P.O. Box 85500
Han Boter
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509046
h.boter@azu.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL10 |
| NTR-old | NTR25 |
| Other | : N/A |
| ISRCTN | ISRCTN68736636 |
Summary results
<br>
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.