The European First Episode Schizophrenia Trial (EUFEST): Comparison of outcome in first episode schizophrenia with different low dose antipsychotic drug regimens

Completed

Conditions: Schizophrenia, schizophreniform, or schizoaffective disorder
Mental and Behavioural Disorders
Schizophrenia

Registration Number: ISRCTN68736636

Lead Sponsor: European Group for Research in Schizophrenia (EGRIS) (Austria)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
At regular time intervals patients are followed-up until 12 months after recruitment: <br>1. Psychopathology - positive symptoms, negative symptoms, depression, agitation-excitement, disorganisation<br>2. Side effects - extrapyramidal symptoms (EPS) side-effect profile, sexual side effects and weight gain<br>3. Compliance<br>4. Social needs<br>5. Quality of life<br>6. Substance abuse<br>7. Neurocognitive functioning<br>8. Genetic determinants of response to antipsychotic drugs<br>9. Natural history of schizophrenia