Eff ectiveness of antipsychotic drugs in fi rst-episode schizophrenia and schizophreniform disorder : an open randomised clinical trial

Methods We did an open randomised controlled trial of haloperidol versus second-generation antipsychotic drugs in 50 sites, in 14 countries. Eligible patients were aged 18–40 years, and met diagnostic criteria for schizophrenia, schizophreniform disorder, or schizoaff ective disorder. 498 patients were randomly assigned by a web-based online system to haloperidol (1–4 mg per day; n=103), amisulpride (200–800 mg per day; n=104), olanzapine (5–20 mg per day; n=105), quetiapine (200–750 mg per day; n=104), or ziprasidone (40–160 mg per day; n=82); follow-up was at 1 year. The primary outcome measure was all-cause treatment discontinuation. Patients and their treating physicians were not blinded to the assigned treatment. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN68736636.